Stryker Corporation Stryker Badge Cryptographic Module Version: 3.4.0 FIPS 140-3 Non-Proprietary Security Policy FIPS Security Level: 1 Document Version: 1.0 Prepared for: Prepared by: Stryker Corporation Corsec Security, Inc. 3030 Orchard Parkway 12600 Fair Lakes Circle, Suite 210 San Jose, CA 95134 Fairfax, VA 22033 United States of America United States of America Phone: +1 800 331 6356 Phone: +1 703 267 6050 www.stryker.com www.corsec.com FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 2 of 51 Table of Contents 1. General..................................................................................................................................................5 1.1 Overview.................................................................................................................................................5 1.2 Security Levels.........................................................................................................................................6 2. Cryptographic Module Specification .......................................................................................................7 2.1 Description..............................................................................................................................................7 2.2 Tested and Vendor Affirmed Module Version and Identification ..........................................................8 2.3 Excluded Components ............................................................................................................................9 2.4 Modes of Operation................................................................................................................................9 2.5 Algorithms............................................................................................................................................ 10 2.6 Security Function Implementations..................................................................................................... 13 2.7 Algorithm Specific Information............................................................................................................ 19 2.8 RNG and Entropy ................................................................................................................................. 21 2.9 Key Generation .................................................................................................................................... 21 2.10 Key Establishment................................................................................................................................ 22 2.11 Industry Protocols................................................................................................................................ 22 3. Cryptographic Module Interfaces .........................................................................................................23 3.1 Ports and Interfaces............................................................................................................................. 23 4. Roles, Services, and Authentication......................................................................................................24 4.1 Authentication Methods...................................................................................................................... 24 4.2 Roles..................................................................................................................................................... 24 4.3 Approved Services ............................................................................................................................... 24 4.4 Non-Approved Services ....................................................................................................................... 30 4.5 External Software/Firmware Loaded................................................................................................... 30 5. Software/Firmware Security ................................................................................................................31 5.1 Integrity Techniques ............................................................................................................................ 31 5.2 Initiate on Demand .............................................................................................................................. 31 6. Operational Environment.....................................................................................................................32 6.1 Operational Environment Type and Requirements............................................................................. 32 7. Physical Security ..................................................................................................................................33 8. Non-Invasive Security ..........................................................................................................................34 9. Sensitive Security Parameters Management.........................................................................................35 9.1 Storage Areas....................................................................................................................................... 35 9.2 SSP Input-Output Methods.................................................................................................................. 35 9.3 SSP Zeroization Methods..................................................................................................................... 35 9.4 SSPs...................................................................................................................................................... 36 9.5 Transitions............................................................................................................................................ 41 10. Self-Tests.............................................................................................................................................42 10.1 Pre-Operational Self-Tests................................................................................................................... 42 10.2 Conditional Self-Tests .......................................................................................................................... 42 FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 3 of 51 10.3 Periodic Self-Test Information............................................................................................................. 44 10.4 Error States .......................................................................................................................................... 45 10.5 Operator Initiation of Self-Tests .......................................................................................................... 45 11. Life-Cycle Assurance.............................................................................................................................46 11.1 Installation, Initialization, and Startup Procedures ............................................................................. 46 11.2 Administrator Guidance....................................................................................................................... 46 11.3 Non-Administrator Guidance............................................................................................................... 47 11.4 Design and Rules.................................................................................................................................. 47 12. Mitigation of Other Attacks..................................................................................................................48 12.1 Attack List............................................................................................................................................. 48 12.2 Mitigation Effectiveness ...................................................................................................................... 48 12.3 Guidance and Constraints.................................................................................................................... 48 Appendix A. Acronyms and Abbreviations..........................................................................................49 FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 4 of 51 List of Tables Table 1: Security Levels ..............................................................................................................................................6 Table 2: Tested Module Identification – Software, Firmware, Hybrid (Executable Code Sets) .................................9 Table 3: Tested Operational Environments - Software, Firmware, Hybrid................................................................9 Table 4: Modes List and Description ....................................................................................................................... 10 Table 5: Approved Algorithms - Approved.............................................................................................................. 12 Table 6: Approved Algorithms - Legacy................................................................................................................... 12 Table 7: Vendor-Affirmed Algorithms ..................................................................................................................... 12 Table 8: Security Function Implementations........................................................................................................... 18 Table 9: Ports and Interfaces................................................................................................................................... 23 Table 10: Roles ........................................................................................................................................................ 24 Table 11: Approved Services ................................................................................................................................... 30 Table 12: Storage Areas........................................................................................................................................... 35 Table 13: SSP Input-Output Methods...................................................................................................................... 35 Table 14: SSP Zeroization Methods......................................................................................................................... 35 Table 15: SSP Table 1............................................................................................................................................... 39 Table 16: SSP Table 2............................................................................................................................................... 41 Table 17: Pre-Operational Self-Tests....................................................................................................................... 42 Table 18: Conditional Self-Tests .............................................................................................................................. 44 Table 19: Pre-Operational Periodic Information..................................................................................................... 44 Table 20: Conditional Periodic Information ............................................................................................................ 45 Table 21: Error States.............................................................................................................................................. 45 Table 22: Acronyms and Abbreviations................................................................................................................... 49 List of Figures Figure 1: Module Block Diagram ................................................................................................................................8 FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 5 of 51 1. General 1.1 Overview This is a non-proprietary Cryptographic Module Security Policy for the Stryker Badge Cryptographic Module (firmware version: 3.4.0) from Stryker Corporation (Stryker). This Security Policy describes how the Stryker Badge Cryptographic Module meets the security requirements of Federal Information Processing Standards (FIPS) Publication 140-3, which details the U.S. and Canadian government requirements for cryptographic modules. More information about the FIPS 140-3 standard and validation program is available on the Cryptographic Module Validation Program (CMVP) website, which is maintained by the National Institute of Standards and Technology (NIST) and the Canadian Centre for Cyber Security (CCCS). This document also describes how to run the module in a secure Approved mode of operation. This policy was prepared as part of the Level 1 FIPS 140-3 validation of the module. The Stryker Badge Cryptographic Module is referred to in this document as “Stryker Badge Crypto Module” or “module”. 1.1.1 References This document deals only with operations and capabilities of the module in the technical terms of a FIPS 140-3 cryptographic module security policy. More information is available on the module from the following sources: • The Stryker website (www.stryker.com) contains information on the full line of products from Stryker. • The search page on the CMVP website (https://csrc.nist.gov/Projects/cryptographic-module-validation- program/Validated-Modules/Search) can be used to locate and obtain vendor contact information for technical or sales-related questions about the module. 1.1.2 Document Organization ISO/IEC 19790 Annex B uses the same section naming convention as ISO/IEC 19790 section 7 - Security requirements. For example, Annex B section B.2.1 is named “General” and B.2.2 is named “Cryptographic module specification,” which is the same as ISO/IEC 19790 section 7.1 and section 7.2, respectively. Therefore, the format of this Security Policy is presented in the same order as indicated in Annex B, starting with “General” and ending with “Mitigation of other attacks.” If sections are not applicable, they have been marked as such in this document. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 6 of 51 1.2 Security Levels The Stryker Badge Cryptographic Module is validated at the FIPS 140-3 section levels shown in the table below. Section Title Security Level 1 General 1 2 Cryptographic module specification 1 3 Cryptographic module interfaces 1 4 Roles, services, and authentication 1 5 Software/Firmware security 1 6 Operational environment 1 7 Physical security 1 8 Non-invasive security N/A 9 Sensitive security parameter management 1 10 Self-tests 1 11 Life-cycle assurance 1 12 Mitigation of other attacks 1 Overall Level 1 Table 1: Security Levels FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 7 of 51 2. Cryptographic Module Specification 2.1 Description 2.1.1 Purpose and Use Stryker Corporation is a global leader in medical technologies, offering innovative products and services in medsurg, neurotechnology, orthopedics, and spine that help improve patient and healthcare outcomes. Stryker’s Vocera Badges are wearable communication devices that enable clinician agility and accelerate patient care. Small and lightweight, the Vocera Badges redefine healthcare communications by bringing together voice calling, secure messaging, alerts, and alarms in a lightweight wearable. Communications are protected via industry- standard secure wireless communications protocols. The Stryker Badge Cryptographic Module is a firmware module that is installed on the badge, and badge applications can leverage the module’s cryptographic services (including encryption/decryption, hashing, digital signature functions, and random number generation) needed to support secure communications. 2.1.2 Module Type The Stryker Badge Cryptographic Module 3.4.0 is a Firmware module. 2.1.3 Module Embodiment The Stryker Badge Cryptographic Module has a Multi-Chip Standalone embodiment. 2.1.4 Cryptographic Boundary The cryptographic boundary is the contiguous perimeter that surrounds all memory-mapped functionality provided by the module when loaded and stored in the host platform’s memory. The cryptographic boundary of the module consists of the following executable file and digest file listed below: • fips.so (module binary) • fipsmodule.cnf (digest for module integrity test) Figure 1 is a block diagram of the module executing in memory and its interactions with surrounding firmware components, as well as the module’s cryptographic boundary and Tested Operational Environment’s Physical Perimeter (TOEPP). FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 8 of 51 Application Calling Function Operating System CPU Memory Storage Ports Caller CSPs Stryker Badge Cryptographic Module KEY: Cryptographic Boundary TOEPP Data Input Data Output Control Input Control Output Status Output System Calls System Calls, Data System calls C Runtime Libraries Figure 1: Module Block Diagram The module is entirely contained within the physical perimeter. 2.1.5 Tested Operational Environment’s Physical Perimeter (TOEPP) As a firmware cryptographic module, the TOEPP of the cryptographic module is defined by each host platform (Stryker’s Vocera Badges) on which the module is installed. 2.2 Tested and Vendor Affirmed Module Version and Identification 2.2.1 Tested Module Identification – Hardware This section is only applicable for hardware modules. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 9 of 51 2.2.2 Tested Module Identification – Software, Firmware, Hybrid (Executable Code Sets) The table below lists the executable code sets of the module. Package or File Name Software/ Firmware Version Features Integrity Test fips.so 3.4.0 HMAC-SHA2-256 (Single Encompassing) Table 2: Tested Module Identification – Software, Firmware, Hybrid (Executable Code Sets) 2.2.3 Tested Module Identification – Hybrid Disjoint Hardware This section is only applicable to hybrid modules. 2.2.4 Tested Operational Environments – Software, Firmware, Hybrid The module was tested and found to be compliant with FIPS 140-3 requirements on the environments listed in the table below. Operating System Hardware Platform Processors PAA/PAI Hypervisor or Host OS Version(s) BadgeOS 5 V5000 ARM Cortex-A7 No 3.4.0 BadgeOS 7 B7000 ARM Cortex-A53 No 3.4.0 Table 3: Tested Operational Environments - Software, Firmware, Hybrid 2.2.5 Vendor-Affirmed Operational Environments – Software, Firmware, Hybrid There are no vendor-affirmed operational environments claimed. 2.3 Excluded Components The module does not exclude any components from the requirements. 2.4 Modes of Operation 2.4.1 Modes List and Description The table below lists the modes of operation supported by the module. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 10 of 51 Mode Name Description Type Status Indicator Approved The Approved mode of operation Approved EVP_default_properties_is_fips_enabled() returns 1 Table 4: Modes List and Description 2.5 Algorithms 2.5.1 Approved Algorithms Validation certificates for each Approved algorithm are listed in the table below. Approved Algorithm CAVP Cert Properties Reference AES-CBC A7294 Direction - Decrypt, Encrypt Key Length - 128, 192, 256 SP 800-38A AES-CCM A7294 Key Length - 128, 192, 256 SP 800-38C AES-CMAC A7294 Direction - Generation, Verification Key Length - 128, 192, 256 SP 800-38B AES-CTR A7294 Direction - Decrypt, Encrypt Key Length - 128, 192, 256 SP 800-38A AES-ECB A7294 Direction - Decrypt, Encrypt Key Length - 128, 192, 256 SP 800-38A AES-GCM A7294 Direction - Decrypt, Encrypt IV Generation - Internal IV Generation Mode - 8.2.1 Key Length - 128, 192, 256 SP 800-38D AES-KW A7294 Direction - Decrypt, Encrypt Key Length - 128, 192, 256 SP 800-38F AES-KWP A7294 Direction - Decrypt, Encrypt Key Length - 128, 192, 256 SP 800-38F Counter DRBG A7294 Prediction Resistance - Yes Mode - AES-128, AES-192, AES-256 Derivation Function Enabled - No, Yes SP 800-90A Rev. 1 DSA KeyGen (FIPS186-4) A7294 L - 2048 N - 224, 256 FIPS 186-4 ECDSA KeyGen (FIPS186-5) A7294 Curve - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-224, P- 256, P-384, P-521 Secret Generation Mode - testing candidates FIPS 186-5 ECDSA KeyVer (FIPS186-5) A7294 Curve - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-224, P- 256, P-384, P-521 FIPS 186-5 ECDSA SigGen (FIPS186-5) A7294 Curve - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-224, P- 256, P-384, P-521 Hash Algorithm - SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA3-224, SHA3-256, SHA3-384, SHA3-512 FIPS 186-5 ECDSA SigVer (FIPS186-5) A7294 Curve - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-224, P- 256, P-384, P-521 Hash Algorithm - SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA3-224, SHA3-256, SHA3-384, SHA3-512 FIPS 186-5 Hash DRBG A7294 Prediction Resistance - Yes Mode - SHA-1, SHA2-256, SHA2-512 SP 800-90A Rev. 1 HMAC DRBG A7294 Prediction Resistance - Yes Mode - SHA-1, SHA2-256, SHA2-512 SP 800-90A Rev. 1 HMAC-SHA-1 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 HMAC-SHA2-224 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 11 of 51 Algorithm CAVP Cert Properties Reference HMAC-SHA2-256 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 HMAC-SHA2-384 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 HMAC-SHA2-512 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 HMAC-SHA3-224 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 HMAC-SHA3-256 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 HMAC-SHA3-384 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 HMAC-SHA3-512 A7294 Key Length - Key Length: 8-524288 Increment 8 FIPS 198-1 KAS-ECC-SSC Sp800-56Ar3 A7294 Domain Parameter Generation Methods - B-233, B-283, B-409, B-571, K- 233, K-283, K-409, K-571, P-224, P-256, P-384, P-521 Scheme - ephemeralUnified - KAS Role - initiator, responder SP 800-56A Rev. 3 KAS-FFC-SSC Sp800-56Ar3 A7294 Domain Parameter Generation Methods - FB, FC, ffdhe2048, ffdhe3072, ffdhe4096, ffdhe6144, ffdhe8192 Scheme - dhEphem - KAS Role - initiator, responder SP 800-56A Rev. 3 KDF SRTP (CVL) A7294 AES Key Length - 128, 192, 256 SP 800-135 Rev. 1 KTS-IFC A7294 Modulo - 2048, 3072, 4096, 6144 Key Generation Methods - rsakpg1-basic , rsakpg1-crt , rsakpg1-prime- factor, rsakpg2-basic , rsakpg2-crt , rsakpg2-prime-factor Scheme - KTS-OAEP-basic - KAS Role - initiator, responder Key Transport Method - Key Length - 1024 SP 800-56B Rev. 2 PBKDF A7294 Iteration Count - Iteration Count: 1-10000000 Increment 1 Password Length - Password Length: 8-128 Increment 8 SP 800-132 RSA Decryption Primitive Sp800-56Br2 (CVL) A7294 Modulo - 2048, 3072, 4096 SP 800-56B Rev. 2 RSA KeyGen (FIPS186-5) A7294 Key Generation Mode - probableWithProbableAux Modulo - 2048, 3072, 4096, 8192 Primality Tests - 2powSecStr Private Key Format - standard FIPS 186-5 RSA SigGen (FIPS186-5) A7294 Modulo - 2048, 3072, 4096 Signature Type - pkcs1v1.5, pss FIPS 186-5 RSA SigVer (FIPS186-5) A7294 Modulo - 2048, 3072, 4096 Signature Type - pkcs1v1.5, pss FIPS 186-5 Safe Primes Key Generation A7294 Safe Prime Groups - ffdhe2048, ffdhe3072, ffdhe4096, ffdhe6144, ffdhe8192 SP 800-56A Rev. 3 Safe Primes Key Verification A7294 Safe Prime Groups - ffdhe2048, ffdhe3072, ffdhe4096, ffdhe6144, ffdhe8192 SP 800-56A Rev. 3 SHA-1 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 180-4 SHA2-224 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 180-4 SHA2-256 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 180-4 SHA2-384 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 180-4 SHA2-512 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 180-4 SHA3-224 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 SHA3-256 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 SHA3-384 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 SHA3-512 A7294 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 TLS v1.2 KDF RFC7627 (CVL) A7294 Hash Algorithm - SHA2-256, SHA2-384, SHA2-512 SP 800-135 Rev. 1 TLS v1.3 KDF (CVL) A7294 HMAC Algorithm - SHA2-256, SHA2-384 KDF Running Modes - DHE, PSK, PSK-DHE SP 800-135 Rev. 1 FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 12 of 51 Table 5: Approved Algorithms - Approved Legacy Algorithm CAVP Cert Properties Reference DSA PQGGen (FIPS186-4) A7294 L - 2048 N - 224, 256 Hash Algorithm - SHA2-224, SHA2-256, SHA2-384, SHA2-512 FIPS 186-4 ECDSA KeyVer (FIPS186-4) A7294 Curve - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-192, P- 224, P-256, P-384, P-521 FIPS 186-4 ECDSA SigVer (FIPS186-4) A7294 Curve - B-163, B-233, B-283, B-409, B-571, K-163, K-233, K-283, K-409, K- 571, P-192, P-224, P-256, P-384, P-521 Hash Algorithm - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA3- 224, SHA3-256, SHA3-384, SHA3-512 FIPS 186-4 RSA SigVer (FIPS186-2) A7294 Signature Type - PKCS 1.5, PKCSPSS Modulo - 1024, 1536, 2048, 3072, 4096 FIPS 186-4 RSA SigVer (FIPS186-4) A7294 Signature Type - PKCS 1.5, PKCSPSS Modulo - 1024, 2048, 3072, 4096 FIPS 186-4 Table 6: Approved Algorithms - Legacy 2.5.2 Vendor-Affirmed Algorithms The vendor affirms the following cryptographic security methods: • Cryptographic key generation – In compliance with section 4 of NIST SP 800-133rev2, the module uses its Approved DRBG to generate random values and seeds used for asymmetric key generation. The generated seed is an unmodified output from the DRBG. Name Properties Implementation Reference CKG Section 4 Key Type:Asymmetric N/A SP 800-133r2 Section 4, example 1: U is output directly without XORing V Table 7: Vendor-Affirmed Algorithms 2.5.3 Non-Approved, Allowed Algorithms The module does not support the use of non-Approved algorithms that are allowed for use in the Approved mode of operation. N/A for this module. 2.5.4 Non-Approved, Allowed Algorithms with No Security Claimed The module does not support the use of non-Approved algorithms that are allowed in the Approved mode of operation for which no security is claimed. N/A for this module. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 13 of 51 2.5.5 Non-Approved, Not Allowed Algorithms The module does not support the use of non-Approved/non-allowed algorithms in the Approved mode of operation. N/A for this module. 2.6 Security Function Implementations The table below lists the security function implementations for this module. Name Type Description Properties Algorithms AES for Symmetric Encryption BC-UnAuthEncrypt AES Key is used for symmetric encryption AES-CBC: (A7294) AES-CTR: (A7294) AES-ECB: (A7294) AES for Symmetric Decryption BC-UnAuthDecrypt AES Key is used for symmetric decryption AES-CBC: (A7294) AES-CTR: (A7294) AES-ECB: (A7294) AES for Authenticated Symmetric Encryption BC-AuthEncrypt AES CCM Key or AES GCM Key is used for authenticated symmetric encryption AES-GCM: (A7294) AES-CCM: (A7294) AES-KW: (A7294) AES-KWP: (A7294) AES for Authenticated Symmetric Decryption BC-AuthDecrypt AES CCM Key or AES GCM Key is used for authenticated symmetric decryption AES-GCM: (A7294) AES-CCM: (A7294) AES-KW: (A7294) AES-KWP: (A7294) AES-CMAC for Message Authentication MAC AES CMAC Key is used for generating and verifying symmetric digests AES-CMAC: (A7294) AES-ECB: (A7294) DRBG DRBG DRBG for generating random bits Counter DRBG: (A7294) Hash DRBG: (A7294) HMAC DRBG: (A7294) ECDSA for Key Generation AsymKeyPair-KeyGen Used to generate the ECDSA asymmetric key pair ECDSA KeyGen (FIPS186-5): (A7294) Counter DRBG: (A7294) CKG Section 4: () Key Type: Asymmetric and Symmetric Hash DRBG: (A7294) HMAC DRBG: (A7294) ECDSA for Key Verification AsymKeyPair-KeyVer Used for verifying the ECDSA Public ECDSA KeyVer (FIPS186- 5): (A7294) ECDSA for Key Verification (Legacy) AsymKeyPair-KeyVer Used for verifying the ECDSA public key using legacy parameters Publication:FIPS 186-4, IG C.M ECDSA KeyVer (FIPS186- 4): (A7294) FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 14 of 51 Name Type Description Properties Algorithms ECDSA for Signature Generation DigSig-SigGen ECDSA Private Key is used for generating digital signatures. ECDSA SigGen (FIPS186- 5): (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) Counter DRBG: (A7294) Hash DRBG: (A7294) HMAC DRBG: (A7294) ECDSA for Signature Verification DigSig-SigVer ECDSA Public Key is used for verifying digital signatures ECDSA SigVer (FIPS186- 5): (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) ECDSA for Signature Verification (Legacy) DigSig-SigVer ECDSA Public Key is used for verifying digital signatures using legacy parameters ECDSA SigVer (FIPS186- 4): (A7294) SHA-1: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) RSA for Key Generation AsymKeyPair-KeyGen Used to generate the RSA asymmetric key pair RSA KeyGen (FIPS186- 5): (A7294) Counter DRBG: (A7294) CKG Section 4: () Key Type: Asymmetric and Symmetric Hash DRBG: (A7294) HMAC DRBG: (A7294) RSA for Signature Generation DigSig-SigGen RSA Private Key is used for generating digital signatures RSA SigGen (FIPS186-5): (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-512: (A7294) Counter DRBG: (A7294) FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 15 of 51 Name Type Description Properties Algorithms RSA for Signature Verification DigSig-SigVer RSA Public Key is used for verifying digital signatures RSA SigVer (FIPS186-5): (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) RSA for Signature Verification (Legacy) DigSig-SigVer RSA Public Key is used for verifying digital signatures using legacy parameters RSA SigVer (FIPS186-2): (A7294) RSA SigVer (FIPS186-4): (A7294) SHA-1: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) RSA for Key Encapsulation AsymKeyPair-Encap RSA-OAEP used for key encapsulation KTS-IFC: (A7294) RSA KeyGen (FIPS186- 5): (A7294) RSA Decryption Primitive Sp800-56Br2: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) CKG Section 4: () Key Type: Asymmetric Counter DRBG: (A7294) AES-CTR: (A7294) Hash DRBG: (A7294) SHA-1: (A7294) HMAC DRBG: (A7294) HMAC-SHA-1: (A7294) HMAC-SHA2-256: (A7294) HMAC-SHA2-512: (A7294) FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 16 of 51 Name Type Description Properties Algorithms RSA for Key Decapsulation AsymKeyPair-Decap RSA-OAEP used for key decapsulation Publication:SP 800-56B Rev. 2 KTS-IFC: (A7294) RSA KeyGen (FIPS186- 5): (A7294) RSA Decryption Primitive Sp800-56Br2: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) CKG Section 4: () Key Type: Asymmetric Counter DRBG: (A7294) AES-CTR: (A7294) Hash DRBG: (A7294) SHA-1: (A7294) HMAC DRBG: (A7294) HMAC-SHA-1: (A7294) HMAC-SHA2-256: (A7294) HMAC-SHA2-512: (A7294) SHA for Message Digest SHA SHA used for generating message digests SHA-1: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) Safe Primes for Key Generation AsymKeyPair-KeyGen CKG Used to generate the DHE asymmetric key pair Safe Primes Key Generation: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) Counter DRBG: (A7294) AES-CTR: (A7294) Hash DRBG: (A7294) SHA-1: (A7294) HMAC DRBG: (A7294) HMAC-SHA-1: (A7294) HMAC-SHA2-256: (A7294) HMAC-SHA2-512: (A7294) CKG Section 4: () Key Type: Asymmetric FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 17 of 51 Name Type Description Properties Algorithms Safe Primes for Key Verification AsymKeyPair-KeyVer Used to verify the DHE Public Key Safe Primes Key Verification: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) Counter DRBG: (A7294) AES-CTR: (A7294) Hash DRBG: (A7294) SHA-1: (A7294) HMAC DRBG: (A7294) HMAC-SHA-1: (A7294) HMAC-SHA2-256: (A7294) HMAC-SHA2-512: (A7294) HMAC for Message Authentication MAC HMAC Key is used for performing keyed hash operations HMAC-SHA-1: (A7294) HMAC-SHA2-224: (A7294) HMAC-SHA2-256: (A7294) HMAC-SHA2-384: (A7294) HMAC-SHA2-512: (A7294) HMAC-SHA3-224: (A7294) HMAC-SHA3-256: (A7294) HMAC-SHA3-384: (A7294) HMAC-SHA3-512: (A7294) SHA-1: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) PBKDF PBKDF Used for deriving key from Passphrase PBKDF: (A7294) SHA-1: (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 18 of 51 Name Type Description Properties Algorithms DH Shared Secret Computation CKG KAS-SSC Used to compute the shared secret "Z" KAS-FFC-SSC Sp800- 56Ar3: (A7294) Safe Primes Key Generation: (A7294) Safe Primes Key Verification: (A7294) DSA KeyGen (FIPS186- 4): (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) CKG Section 4: () Key Type: Asymmetric Counter DRBG: (A7294) DSA PQGGen (FIPS186- 4): (A7294) ECDH Shared Secret Computation CKG KAS-SSC Used to compute the shared secret "Z" KAS-ECC-SSC Sp800- 56Ar3: (A7294) ECDSA KeyGen (FIPS186-5): (A7294) ECDSA KeyVer (FIPS186- 5): (A7294) SHA2-224: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SHA3-224: (A7294) SHA3-256: (A7294) SHA3-384: (A7294) SHA3-512: (A7294) CKG Section 4: () Key Type: Asymmetric Counter DRBG: (A7294) TLS Key Derivation KAS-135KDF TLS v1.2/1.3 KDF used to derive keying material TLS v1.2 KDF RFC7627: (A7294) TLS v1.3 KDF: (A7294) HMAC-SHA2-256: (A7294) HMAC-SHA2-384: (A7294) HMAC-SHA2-512: (A7294) SHA2-256: (A7294) SHA2-384: (A7294) SHA2-512: (A7294) SRTP Key Derivation KAS-135KDF SRTP KDF used to derive keying material KDF SRTP: (A7294) AES-ECB: (A7294) Table 8: Security Function Implementations FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 19 of 51 2.7 Algorithm Specific Information 2.7.1 AES-CTR The operator is responsible must not reuse a counter value under the same key. Otherwise, the operator may compromise the confidentiality of the ciphertext. 2.7.2 AES-GCM The module does not implement the TLS protocol. However, the operator may AES GCM in the context of the TLS protocol versions 1.2 and 1.3. To meet the AES GCM (key/IV) pair uniqueness requirements from NIST SP 800-38D, the module complies with FIPS 140-3 IG C.H as follows: • For TLS v1.2, the module supports acceptable AES GCM cipher suites from section 3.3.1.1 of NIST SP 800- 52rev2. The protocol’s implementation is contained within the boundary of the module, and the generated IV is only used in the context of the AES GCM encryption executing the provisions of the TLS 1.2 protocol. The mechanism for IV generation falls into scenario 1 in FIPS 140-3 IG C.H and is compliant with RFC 5288. The counter portion of the IV is strictly increasing. When the IV exhausts the maximum number of possible values for a given session key, a failure in encryption will occur and a handshake to establish a new encryption key will be required. It is the responsibility of the module operator (i.e., the first party, client, or server) to trigger this handshake in accordance with RFC 5246 when this condition is encountered. • For TLS v1.3, the module supports acceptable AES GCM cipher suites from section 3.3.1.2 of NIST SP 800- 52rev2. The protocol’s implementation is contained within the boundary of the module, and the generated IV is only used in the context of the AES GCM encryption executing the provisions of the TLS 1.3 protocol. The mechanism for IV generation falls into scenario 5 in FIPS 140-3 IG C.H and is compliant with RFC 8446. Each session employs a “per-record nonce”, a 64-bit sequence number (or IV) maintained separately for reading and writing records. Each sequence number is set to 0 at the beginning of a connection and whenever the key is changed (the first record transmitted under a particular traffic key uses sequence number 0), and the appropriate sequence number is incremented by one after reading or writing each record. Because the size of sequence numbers is 64 bits, they should not wrap. If a sequence number needs to wrap, it is the responsibility of the module operator to either rekey or terminate the connection. The module also supports internal IV generation using the module’s Approved DRBG. As specified in section 8.2.1 of NIST SP 800-38D, internally generated IVs are constructed deterministically, with a length of at least 96 bits. Per NIST SP 800-38D and scenario 2 of FIPS 140-3 IG C.H, the DRBG generates outputs such that the (key/IV) pair collision probability is less than 2-32 . If power to the module is lost and subsequently restored, the calling application must ensure that any AES GCM keys used for encryption or decryption are re-distributed. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 20 of 51 2.7.3 Counter DRBG Counter DRBG defaults to using a derivation function. However, if the operator chooses to use Counter DRBG without a derivation function, an approved entropy source within the TOEPP is required. 2.7.4 DSA FIPS 140-3 IG C.K, Resolution 3 allows DSA KeyGen (FIPS186-4) to be used exclusively in a scheme compliant with SP 800-56A Rev. 3. The module prohibits external applications from invoking DSA KeyGen (FIPS186-4) for other purposes. 2.7.5 ECDSA ECDSA SigVer (FIPS186-4) includes legacy parameters, which include curves with ≤ 112 bits of security strength (B- 163, K-163, and P-192) and SHA-1 for the underlying hash algorithm. FIPS 140-3 IG C.K, Resolution 6 and Additional Comment 2 allow FIPS 186-4 parameters to only be used for verifying ECDSA signatures generated prior to February 5, 2024. 2.7.6 RSA RSA SigVer (FIPS186-2) legacy parameters, which include keys with ≤ 112 bits of security strength (1024 and 1538 bits) and SHA-1 for the underlying hash algorithm. FIPS 140-3 IG C.K, Resolution 6 and Additional Comment 2 allow FIPS 186-2 parameters to only be used for verifying RSA signatures generated prior to September 2020. RSA SigVer (FIPS186-4) legacy parameters, which include keys with ≤ 112 bits of security strength (1024 bits) and SHA-1 for the underlying hash algorithm. FIPS 140-3 IG C.K, Resolution 6 and Additional Comment 2 allow FIPS 186-4 parameters to only be used for verifying RSA signatures generated prior to February 5, 2024. 2.7.7 KAS The module performs assurances for its key agreement schemes as specified in the following sections of NIST SP 800-56Arev3: • Section 5.5.2 (for assurances of domain parameter validity) • Section 5.6.2.1 (for assurances required by the key pair owner) The module includes the capability to provide the required recipient assurance of ephemeral public key validity specified in section 5.6.2.2.2 of NIST SP 800-56Arev3. However, since public keys from other modules are not received directly by this module (those keys are received by the calling application), the module has no knowledge of when a public key is received. Invocation of the proper module services to validate another module’s public key is the responsibility of the calling application. The module implements the following Approved key agreement methods which have been CAVP tested and validated: • KAS-ECC-SSC (FIPS 140-3 IG D.F, Scenario 2 path 1) FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 21 of 51 • KAS-FFC-SSC (FIPS 140-3 IG D.F, Scenario 2 path 1) The module does not establish SSPs using an approved key agreement scheme (KAS). However, it does offer some or all of the underlying KAS cryptographic functionality to be used by an external operator/application as part of an approved KAS. 2.7.8 KTS The module does not establish SSPs using an approved key transport scheme (KTS). However, it does offer approved authentication algorithms that can be used by an external operation/application as part of an approved KTS. Please see Section 2.10.2 for the list of approved authentication algorithms that the module offers. 2.7.9 PBKDF2 The module uses PBKDF2 option 1a from section 5.4 of NIST SP 800-132. The iteration count shall be selected as large as possible, as long as the time required to generate the resultant key is acceptable for module operators. The minimum iteration count shall be 1000. The length of the password/passphrase used in the PBKDF shall be of at least 20 characters, and shall consist of lower-case, upper-case, and numeric characters. The upper bound for the probability of guessing the value is estimated to be 1/6220 = 10-36 , which is less than 2-112 . As specified in NIST SP 800-132, keys derived from passwords/passphrases may only be used in storage applications. 2.8 RNG and Entropy The cryptographic module invokes a GET command to obtain entropy for random number generation (the module requests 256 bits of entropy from the calling application per request), and then passively receives entropy from the calling application while having no knowledge of the entropy source and exercising no control over the amount or the quality of the obtained entropy. The calling application and its entropy sources are located within the operational environment inside the module’s physical perimeter but outside the cryptographic boundary. Thus, there is no assurance of the minimum strength of the generated keys. 2.9 Key Generation The cryptographic module uses its counter-based DRBG to generate seeds used for asymmetric key generation. The generated seed is an unmodified output from the DRBG. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 22 of 51 2.10 Key Establishment 2.10.1 Key Agreement Information The cryptographic module provides the following shared secret computation and key derivation cryptographic primitives necessary to support the DH and ECDH key agreement schemes utilized by the calling application to establish keys. • KAS-ECC-SSC (Elliptic-curve Diffie-Hellman) with TLS v1.2 KDF RFC7627 • KAS-ECC-SSC (Elliptic-curve Diffie-Hellman) with TLS v1.3 KDF • KAS-FFC-SSC (Diffie-Hellman) with TLS v1.2 KDF RFC7627 • KAS-FFC-SSC (Diffie-Hellman) with TLS v1.3 KDF These methods are not used to establish keys into the module. 2.10.2 Key Transport Information The cryptographic module provides the following cryptographic algorithms necessary to support AES-based key transport mechanisms utilized by the calling application to establish keys. • Any approved mode of AES with any approved MAC • AES-CCM • AES-GCM • AES-KW • AES-KWP • KTS-IFC These methods are not used to establish keys into the module. 2.11 Industry Protocols The module uses the following industry protocols: • SRTP • TLS 1.2 (with the extended master secret per RFC 7627) • TLS 1.3 No parts of these protocols, other than the Approved cryptographic algorithms and the KDFs, have been tested by the CAVP and CMVP. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 23 of 51 3. Cryptographic Module Interfaces 3.1 Ports and Interfaces The module supports the following four logical interfaces: • Data Input • Data Output • Control Input • Status Output As a firmware library, the cryptographic module has no direct access to any of the host platform’s physical ports, as it communicates only to the calling application via its well-defined API. A mapping of the FIPS-defined interface to the module’s physical ports and logical interfaces can be found in the table below. The module does not output control information and thus has no specified control output interface. Physical Port Logical Interface(s) Data That Passes N/A Data Input Logical interface is defined as API input arguments that provide input data for processing. This includes data to be encrypted, decrypted, signed, verified, and hashed, keys to be used in cryptographic services, random seed material for the DRBG of the module, keying material used as input to key establishment services, and intermediate data required for services. N/A Data Output Logical interface is defined as API output arguments that return generated or processed data back to the caller. This includes data that has been encrypted/decrypted/verified, digital signatures, hashes, random values generated by the DRBG of the module, keys established using key establishment methods of the module, and key components/intermediate data/traffic (client and server data and messages). N/A Control Input Logical interface is defined as API input arguments that are used to initialize and control the operation of the module. This includes API commands invoking cryptographic services, modes, key sizes, etc. used with cryptographic services. N/A Status Output Logical interface is defined as API call return values. This includes status information regarding the module or invoked service/operation. N/A Power None. Table 9: Ports and Interfaces FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 24 of 51 4. Roles, Services, and Authentication 4.1 Authentication Methods The module does not support authentication methods; roles are implicitly assumed by the application accessing services implemented by the module. 4.2 Roles The table below lists the supported roles. Name Type Operator Type Authentication Methods Crypto Officer Role CO None User Role User None Table 10: Roles The operator implicitly assumes the Crypto Officer role to execute the “Show status”, “Perform self-tests on demand”, “Zeroize”, and “Show versioning information” services. The User role implicitly assumes the User role to execute the other approved services listed in the table in Section 4.3 below. The module does not support multiple concurrent operators. The calling application that loaded the module is its only operator. 4.3 Approved Services This module is a firmware library that provides cryptographic functionality to calling applications. As such, the security functions provided by the module are considered the module’s security services. As allowed per section 2.4.C of FIPS 140-3 Implementation Guidance, the module provides indicators for the use of Approved services through a combination of an explicit indication (via a global Approved mode indicator) and an implicit indication (via the successful completion of the service). The keys and Sensitive Security Parameters (SSPs) listed in the table indicate the type of access required using the following notation: • G = Generate: The module generates or derives the SSP. • R = Read: The SSP is read from the module (e.g., the SSP is output). • W = Write: The SSP is updated, imported, or written to the module. • E = Execute: The module uses the SSP in performing a cryptographic operation. • Z = Zeroize: The module zeroizes the SSP. Descriptions of the services available are provided in the table below. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 25 of 51 Name Description Indicator Inputs Outputs Security Functions SSP Access Show status Shows the status of the module None API call Status output None Crypto Officer Perform self-tests on-demand Performs the self-tests on demand when invoking the OSSL_PROVIDER_self_tes t() API command None API call Status output None Crypto Officer FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 26 of 51 Zeroize Zeroizes the SSPs of the module when calling OPENSSL_cleanse() or re- instantiating the module None API call Status output None Crypto Officer - AES Key: Z - AES GCM Key: Z - AES CCM Key: Z - HMAC Key: Z - DHE Private Key: Z - DHE Public Key: Z - ECDHE Private Key: Z - ECDHE Public Key: Z - ECDSA Private Key: Z - ECDSA Public Key: Z - RSA Private Key: Z - RSA Public Key: Z - Passphrase : Z - DRBG Entropy Input: Z - DRBG Seed: Z - DRBG 'Key' Value: Z - DRBG 'C' Value: Z - DRBG 'V' Value: Z - DHE Shared Secret: Z - Derived Keying Material: Z - ECDHE Shared Secret: Z - AES FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 27 of 51 Name Description Indicator Inputs Outputs Security Functions SSP Access CMAC Key: Z Show versioning information Shows the name and version of the module by executing the OSSL_PROVIDER_get_par ams() API function None API call Status output None Crypto Officer Perform symmetric encryption Uses the AES Key to encrypt plaintext into ciphertext Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, AES Key, plaintext Status output, cipherte xt AES for Symmetric Encryption User - AES Key: W,E Perform symmetric decryption Uses the AES Key to decrypt ciphertext into plaintext Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, AES Key, plaintext Status output, plaintex t AES for Symmetric Decryption User - AES Key: W,E Perform authenticat ed symmetric encryption Uses the AES GCM Key or AES CCM Key to encrypt plaintext into ciphertext Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, AES Key, plaintext Status output, cipherte xt AES for Authenticat ed Symmetric Encryption User - AES GCM Key: W,E - AES CCM Key: W,E Perform authenticati on symmetric decryption Uses the AES GCM Key or AES CCM Key to decrypt ciphertext into plaintext Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, AES Key, plaintext Status output, plaintex t AES for Authenticat ed Symmetric Decryption User - AES GCM Key: W,E - AES CCM Key: W,E Generate keyed hash (HMAC) Computes a message authentication code Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, HMAC key, message Status output, MAC HMAC for Message Authenticati on User - HMAC Key: W,E Generate symmetric digest (CMAC) Generates symmetric digest Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, key, plaintext Status output, digest AES-CMAC for Message Authenticati on User - AES CMAC Key: W,E Perform key encapsulati on Performs RSA key encapsulation Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, encryptio n key, key Status output, encrypt ed key RSA for Key Encapsulati on User - RSA Public Key: W,E - Encapsulat ed Key: R,W Perform key decapsulati on Performs RSA key decapsulation Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, decryptio n key, key Status output, decrypt ed key RSA for Key Decapsulati on User - RSA Private Key: W,E - Decapsulat ed Key: R,W FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 28 of 51 Name Description Indicator Inputs Outputs Security Functions SSP Access Generate asymmetric key pair Generates a public and private key pair Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs Status output, key ECDSA for Key Generation RSA for Key Generation Safe Primes for Key Generation User - DHE Private Key: G,R - DHE Public Key: G,R - ECDSA Private Key: G,R - ECDSA Public Key: G,R - ECDHE Private Key: G,R - ECDHE Public Key: G,R - RSA Private Key: G,R - RSA Public Key: G,R - DRBG 'Key' Value: E - DRBG 'C' Value: E - DRBG 'V' Value: E Verify public key Verifies a DHE, ECDSA, or ECDHE public key Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, key Status output ECDSA for Key Verification ECDSA for Key Verification (Legacy) Safe Primes for Key Verification User - DHE Public Key: W,E - ECDHE Private Key: E - ECDSA Public Key: E Generate random number Uses the DRBG to generate random bits Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call Status output, random bits DRBG User - DRBG Entropy Input: W,E - DRBG Seed: G,E - DRBG 'Key' Value: G,E - DRBG 'C' Value: G,E - DRBG 'V' Value: G,E FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 29 of 51 Name Description Indicator Inputs Outputs Security Functions SSP Access Generate digital signature Generates a digital signature using the ECDSA Private Key or RSA Private Key Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, private key, message Status output, signatur e ECDSA for Signature Generation RSA for Signature Generation User - ECDSA Private Key: W,E - RSA Private Key: W,E - DRBG 'Key' Value: E - DRBG 'C' Value: E - DRBG 'V' Value: E Verify digital signature Verifies a digital signature using the ECDSA Public Key or RSA Public Key Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call paramete rs, public key, signature, message Status output ECDSA for Signature Verification ECDSA for Signature Verification (Legacy) RSA for Signature Verification RSA for Signature Verification (Legacy) User - ECDSA Public Key: W,E - RSA Public Key: W,E Generate message digest Uses SHA to hash a message into a message digest Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call, message Status output, hash SHA for Message Digest User Compute shared secret Computes DHE/ECDHE shared secret Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call, paramete rs Status output, shared secret DH Shared Secret Computatio n ECDH Shared Secret Computatio n User - DHE Private Key: W,E - DHE Peer Public Key: W,E - ECDHE Private Key: W,E - ECDHE Peer Public Key: W,E - DHE Shared Secret: G,R - ECDHE Shared Secret: G,R FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 30 of 51 Name Description Indicator Inputs Outputs Security Functions SSP Access Derive key via PBKDF2 Uses PBKDF2 to derive key Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call, passphras e Status output, derived key PBKDF User - Passphrase : W,E - Derived Keying Material: G,R Derive keying material via TLS KDF Uses TLS v1.2/v1.3 KDF to derive keying material Global FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call, master secret Status output, derived key(s). TLS Key Derivation User - Derived Keying Material: G,R - Master Secret: W Derive keying material via SRTP KDF Uses SRTP KDF to derive keying material lobal FIPS indicator: EVP_default_properties_is_fips_en abled() returns 1 API call, master secret Status output, derived key SRTP Key Derivation User - Derived Keying Material: G,R - Master Secret: W Table 11: Approved Services 4.4 Non-Approved Services The module does not support the use of any non-Approved services. N/A for this module. 4.5 External Software/Firmware Loaded The module does not provide the capability to load software from external sources. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 31 of 51 5. Software/Firmware Security 5.1 Integrity Techniques All firmware components within the cryptographic boundary are verified using an Approved integrity technique implemented within the cryptographic module itself. The module implements an HMAC SHA2-256 digest check to test the integrity of the library file; failure of the integrity test for the library file will cause the module to enter a critical error state. The module’s integrity check is performed automatically at module instantiation (i.e., when the module is loaded into memory for execution) without action from the module operator. 5.2 Initiate on Demand The CO can initiate the pre-operational test on demand by re-instantiating the module or issuing the OSSL_PROVIDER_self_test() API command. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 32 of 51 6. Operational Environment 6.1 Operational Environment Type and Requirements The module is a firmware cryptographic library that executes in a Non-Modifiable operational environment. The cryptographic module has control over its own SSPs. The process and memory management functionality of the host device’s OS prevents unauthorized access to plaintext private and secret keys, intermediate key generation values and other SSPs by external processes during module execution. The module only allows access to SSPs through its well-defined API. The operational environment provides the capability to separate individual application processes from each other by preventing uncontrolled access to CSPs and uncontrolled modifications of SSPs regardless of whether this data is in the process memory or stored on persistent storage within the operational environment. Processes that are spawned by the module are owned by the module and are not owned by external processes/operators. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 33 of 51 7. Physical Security The Stryker Badge Cryptographic Module is a multi-chip standalone firmware module contained within a production-grade enclosure that executes on Stryker’s Vocera Badge hardware devices. All components of these devices are made of production-grade materials, and all integrated circuits are coated with commercial standard passivation. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 34 of 51 8. Non-Invasive Security This section is not applicable. There are currently no approved non-invasive mitigation techniques references in Annex F of ISO/IEC 19790. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 35 of 51 9. Sensitive Security Parameters Management 9.1 Storage Areas There are no mechanisms within the module’s cryptographic boundary for the persistent storage of SSPs. The module stores DRBG state values for the lifetime of the DRBG instance. The module uses SSPs passed in on the stack by the calling application and does not store these SSPs beyond the lifetime of the API call. The table below lists sensitive security parameters (SSPs) storage areas for this module. Storage Area Name Description Persistence Type RAM SSPs are stored in RAM temporarily Dynamic Table 12: Storage Areas 9.2 SSP Input-Output Methods The table below lists input and output methods for the module’s SSPs. Section 9.4 below selects from the input and output methods listed and specifies the appropriate parameter in the “Inputs/Outputs” column if applicable to a specific SSP. Name From To Format Type Distribution Type Entry Type SFI or Algorithm API call input External RAM Plaintext Manual Electronic API call output RAM External Plaintext Manual Electronic Table 13: SSP Input-Output Methods 9.3 SSP Zeroization Methods The table below lists SSP zeroization methods for this module Section 9.4 below selects from the zeroization methods listed and specifies the appropriate parameter in the “Zeroization” column if applicable to a specific SSP. Zeroization Method Description Rationale Operator Initiation OPENSSL_cleanse() OPENSSL_cleanse() API call zeroizes SSPs OPENSSL_cleanse() API call zeroizes SSPs by replacing the pointer of the specified length with 0's, yielding the SSP irretrievable The operator calls OPENSSL_cleanse() Reboot Rebooting the host device zeroizes SSPs Rebooting the device clears SSPs in RAM, yielding them irretrievable The operator reboots the host device Table 14: SSP Zeroization Methods FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 36 of 51 9.4 SSPs The module supports the keys and other SSPs listed in the table below. All SSP imports and exports are electronic and performed within the TOEPP. Name Description Size - Strength Type - Category Generated By Established By Used By AES Key Used for symmetric encryption/decryption 128 - 256 - 128 - 256 Symmetric Key - CSP AES for Symmetric Encryption AES for Symmetric Decryption AES GCM Key Used for authenticated symmetric encryption/decryption 128 - 256 - 128 - 256 Symmetric Key - CSP AES for Authenticated Symmetric Encryption AES for Authenticated Symmetric Decryption AES CCM Key Used for authenticated symmetric encryption/decryption 128 - 256 - 128 - 256 Symmetric Key - CSP AES for Authenticated Symmetric Encryption AES for Authenticated Symmetric Decryption AES CMAC Key Used for generating and verifying message authentication 128 - 256 - 128 - 256 Authentication - CSP AES-CMAC for Message Authentication HMAC Key Used for keyed hash messages 160 - 512 - 160 - 512 Authentication - CSP HMAC for Message Authentication DHE Private Key Used for DHE shared secret computation [ffdhe] Between 224 and 400 bits [FB/FC] Between 224 and 256 bits [ffdhe] Between 2048 and 8192 bits - [ffdhe] Between 112 and 200 bits [FB/FC] Between 112 and 128 bits [ffdhe] Between 112 and 200 bits Private - CSP Safe Primes for Key Generation DSA KeyGen (FIPS186-4) (A7294) DH Shared Secret Computation DHE Public Key Sent to peer for DHE shared secret computation [ffdhe] Between 2048 and 8192 bits [FB/FC] 2048 bits - [ffdhe] Between 112 and 200 bits [FB/FC] 112 bits Public - PSP Safe Primes for Key Generation DSA KeyGen (FIPS186-4) (A7294) DH Shared Secret Computation FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 37 of 51 Name Description Size - Strength Type - Category Generated By Established By Used By DHE Peer Public Key Used for DHE shared secret computation. [ffdhe] Between 2048 and 8192 bits [FB/FC] 2048 bits - [ffdhe] Between 112 and 200 bits [FB/FC] 112 bits Public - PSP DHE Shared Secret Shared secret derived from the DHE Private Key and the DHE Public Key. [ffdhe] Between 2048 and 8192 bits [FB/FC] 2048 bits - [ffdhe] Between 112 and 200 bits [FB/FC] 112 bits Shared Secret - CSP DH Shared Secret Computation ECDHE Private Key Used for ECDHE shared secret computation Between 224 and 571 bits - Between 112 and 256 bits Private - CSP ECDSA for Key Generation ECDH Shared Secret Computation ECDHE Public Key Sent to peer for DHE shared secret computation Between 224 and 571 bits - Between 112 and 256 bits Public - PSP ECDSA for Key Generation ECDHE Peer Public Key Used for ECDHE shared secret computation. Between 224 and 571 bits - Between 112 and 256 bits Public - PSP ECDH Shared Secret Computation ECDHE Shared Secret Shared secret derived from the ECDHE Private Key and the ECDHE Public Key. Between 224 and 571 bits - Between 112 and 256 bits Shared Secret - CSP ECDH Shared Secret Computation ECDSA Private Key Used for ECDSA digital signature generation Between 224 and 571 bits - Between 112 and 256 bits Private - CSP ECDSA for Key Generation ECDSA for Signature Generation ECDSA Public Key Used for ECDSA digital signature verification Between 163 and 571 bits - Between 80 and 256 bits Public - PSP ECDSA for Key Generation ECDSA for Signature Verification ECDSA for Signature Verification (Legacy) RSA Private Key Used for RSA digital signature generation and key decapsulation [RSA SigGen] Between 2048 and 4096 bits [KTS-IFC] Between 2048 and 6144 bits - RSA SigGen] Between 112 and 150 bits [KTS-IFC] Between 112 and 176 bits Private - CSP RSA for Key Generation RSA for Signature Generation RSA for Key Decapsulation RSA Public Key Used for RSA digital signature verification and key encapsulation [RSA SigVer] Between 1024 and 4096 bits [KTS-IFC] Between 2048 and 6144 bits - [RSA SigVer] Between 80 and 150 bits [KTS- IFC] Between 112 and 176 bits Public - PSP RSA for Key Generation RSA for Signature Verification RSA for Key Encapsulation FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 38 of 51 Name Description Size - Strength Type - Category Generated By Established By Used By Master Secret Used to generate Derived Keying Material using SRTF KDF or TLS KDF 384 bits - 384 bits Shared Secret - CSP TLS Key Derivation SRTP Key Derivation Derived Keying Material Keying material derived from a key derivation function Between 128 and 256 bits - Between 128 and 256 bits Shared Secret - CSP PBKDF TLS Key Derivation SRTP Key Derivation Encapsulated Key Encapsulated by RSA Public Key. Between 112 and 5680 bits - Between 112 and 256 bits Key - CSP Decapsulated Key Decapsulated by the RSA Private Key. Between 112 and 5680 bits - Between 112 and 256 bits Key - CSP Passphrase Used as input for PBKDF Between 64 and 1024 bits - Between 64 and 1024 bits Passphrase - CSP PBKDF DRBG Entropy Input Entropy input used for the DRBG Seed [Counter DRBG] Between 128 and 512 bits [Hash DRBG] Between 128 and 320 bits [HMAC DRBG] Between 160 and 1024 bits - [Counter DRBG] Between 128 and 512 bits [Hash DRBG] Between 128 and 320 bits [HMAC DRBG] Between 160 and 1024 bits Entropy Input - CSP DRBG DRBG Seed Seed used for the DRBG DRBG] Between 256 and 384 bits [Hash DRBG] 440 or 888 bits [HMAC DRBG] 440 or 888 bits - DRBG] Between 256 and 384 bits [Hash DRBG] 440 or 888 bits [HMAC DRBG] 440 or 888 bits Seed - CSP DRBG DRBG DRBG 'Key' Value DRBG state value [Counter DRBG] Between 128 and 256 bits [HMAC DRBG] 160, 256, or 512 bits - [Counter DRBG] Between 128 and 256 bits [HMAC DRBG] 160, 256, or 512 bits State Value - CSP DRBG DRBG DRBG 'C' Value DRBG state value 440 or 888 bits - 440 or 888 bits State Value - CSP DRBG DRBG FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 39 of 51 Name Description Size - Strength Type - Category Generated By Established By Used By DRBG 'V' Value DRBG state value [Counter DRBG] 128 bits [Hash DRBG] 440 or 888 bits [HMAC DRBG] 160, 256, or 512 bits - [Counter DRBG] 128 bits [Hash DRBG] 440 or 888 bits [HMAC DRBG] 160, 256, or 512 bits State Value - CSP DRBG DRBG Table 15: SSP Table 1 Name Input - Output Storage Storage Duration Zeroization Related SSPs AES Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot AES GCM Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot AES CCM Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot AES CMAC Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot HMAC Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DHE Private Key API call input API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DHE Public Key:Paired With DHE Shared Secret:Derives DHE Peer Public Key:Used With DHE Public Key API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DHE Private Key:Paired With DHE Peer Public Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DHE Private Key:Used With DHE Shared Secret:Derives DHE Shared Secret API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DHE Private Key:Derived From DHE Peer Public Key:Derived From ECDHE Private Key API call input API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot ECDHE Public Key:Paired With ECDHE Public Key:Used With ECDHE Shared Secret:Derives FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 40 of 51 Name Input - Output Storage Storage Duration Zeroization Related SSPs ECDHE Public Key API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot ECDHE Private Key:Paired With ECDHE Peer Public Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot ECDHE Private Key:Used With ECDHE Shared Secret:Derives ECDHE Shared Secret API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted. OPENSSL_cleanse() Reboot ECDHE Private Key:Derived From ECDHE Peer Public Key:Derived From ECDSA Private Key API call input API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot ECDSA Public Key:Paired With ECDSA Public Key API call input API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot ECDSA Private Key:Paired With RSA Private Key API call input API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot RSA Public Key:Paired With Decapsulated Key:Decrypts RSA Public Key API call input API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot RSA Private Key:Paired With Encapsulated Key:Encrypts Master Secret API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot Derived Keying Material API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot Master Secret:Derived From Passphrase:Derived From Encapsulated Key API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot RSA Public Key:Encrypted By Decapsulated Key API call output RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot RSA Private Key:Decrypted By Passphrase API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DRBG Entropy Input API call input RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DRBG Seed RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DRBG Entropy Input:Derived From DRBG 'Key' Value RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DRBG Seed:Derived From DRBG 'C' Value RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DRBG Seed:Derived From FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 41 of 51 Name Input - Output Storage Storage Duration Zeroization Related SSPs DRBG 'V' Value RAM:Plaintext Stored in RAM until OPENSSL_cleanse() is called or the host device is rebooted OPENSSL_cleanse() Reboot DRBG Seed:Derived From Table 16: SSP Table 2 9.5 Transitions The following list specifies applicable transition periods or timeframes where an algorithm or key length transitions from Approved to non-Approved: • Key Sizes: In compliance with NIST SP 800-131A Rev. 2, the module supports algorithms and key lengths that provide a minimum of 112 bits of security strength for applying cryptographic protection. Starting January 1, 2031, the minimum security strength for applying cryptographic protection will be 128 bits, and security strengths between 112 bits and 128 bits will be allowed for legacy use only to process information that is already protected. • SHA-1: The module offers support for SHA-1 for hashing. This implementation will be non-Approved for all uses starting January 1, 2031. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 42 of 51 10. Self-Tests 10.1 Pre-Operational Self-Tests The module performs the pre-operational self-tests listed in the following table. Algorithm or Test Test Properties Test Method Test Type Indicator Details HMAC-SHA2- 256 SHA2-256 SW/FW Integrity SW/FW Integrity Returns 1 if the test succeeds. Returns 0 if the test fails HMAC-SHA2-256 integrity test on fips.so Table 17: Pre-Operational Self-Tests 10.2 Conditional Self-Tests The module performs the conditional self-tests listed in the following table. Algorithm or Test Test Properties Test Method Test Type Indicator Details Conditions AES-GCM Decrypt 256-bit KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Decrypt After pre-operational integrity test AES-GCM Encrypt 256-bit KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Encrypt After pre-operational integrity test AES-ECB 128-bit KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Decrypt After pre-operational integrity test ECDSA SigGen (FIPS186-5) #1 B-233; SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Sign After pre-operational integrity test ECDSA SigVer (FIPS186-5) #1 B-233; SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Verify After pre-operational integrity test ECDSA SigGen (FIPS186-5) #2 P-224; SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Sign After pre-operational integrity test ECDSA SigVer (FIPS186-5) #2 P-224; SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Verify After pre-operational integrity test ECDSA SigVer (Legacy) P-192; SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Verify After pre-operational integrity test FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 43 of 51 Algorithm or Test Test Properties Test Method Test Type Indicator Details Conditions RSA SigGen (FIPS186-5) 2048-bits; SHA2- 256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Sign After pre-operational integrity test RSA SigVer (FIPS186-5) 2048-bits; SHA2- 256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Verify After pre-operational integrity test RSA SigVer (Legacy) 1024/1536-bits; SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Verify After pre-operational integrity test Counter DRBG AES-128-CTR; with derivation function; KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Generate/Initiate/Reseed After pre-operational integrity test Hash DRBG SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Generate/Initiate/Reseed After pre-operational integrity test HMAC DRBG SHA-1 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Generate/Initiate/Reseed After pre-operational integrity test SHA2-512 SHA2-512 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Digest After pre-operational integrity test SHA3-256 SHA3-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Digest After pre-operational integrity test HMAC-SHA2- 256 SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Hashed Message After pre-operational integrity test KAS-ECC-SSC Sp800-56Ar3 P-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Shared Secret Computation After pre-operational integrity test KAS-FFC-SSC Sp800-56Ar3 ffdhe2048 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Shared Secret Computation After pre-operational integrity test PBKDF SHA2-256; 4096 iterations KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Derive After pre-operational integrity test KTS-IFC 2048-bits KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Encrypt After pre-operational integrity test TLS v1.2 KDF RFC7627 SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Derive After pre-operational integrity test FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 44 of 51 Algorithm or Test Test Properties Test Method Test Type Indicator Details Conditions TLS v1.3 KDF SHA2-256 KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Derive After pre-operational integrity test KDF SRTP AES-128-CTR KAT CAST Returns 1 if the test succeeds. Returns 0 if the test fails Derive After pre-operational integrity test ECDSA KeyGen (FIPS186-5) PCT PCT Returns 1 if the test succeeds. Returns 0 if the test fails Sign/Verify When the requested service requires the generation of an ECDH/ECDSA key pair RSA KeyGen (FIPS186-5) PCT PCT Returns 1 if the test succeeds. Returns 0 if the test fails Sign/Verify When the requested service requires the generation of an RSA key pair DSA KeyGen (FIPS186-4) PCT PCT Returns 1 if the test succeeds. Returns 0 if the test fails Key Generation When the requested service requires the generation of a DHE key pair Safe Primes Key Generation PCT PCT Returns 1 if the test succeeds. Returns 0 if the test fails Key Generation When the requested service requires the generation of an DHE key pair Table 18: Conditional Self-Tests 10.3 Periodic Self-Test Information The table below specifies the module’s periodic self-test information. Algorithm or Test Test Method Test Type Period Periodic Method HMAC-SHA2-256 SW/FW Integrity SW/FW Integrity On Demand Manually Table 19: Pre-Operational Periodic Information Algorithm or Test Test Method Test Type Period Periodic Method AES-GCM Decrypt KAT CAST On Demand Manually AES-GCM Encrypt KAT CAST On Demand Manually AES-ECB KAT CAST On Demand Manually ECDSA SigGen (FIPS186- 5) #1 KAT CAST On Demand Manually ECDSA SigVer (FIPS186- 5) #1 KAT CAST On Demand Manually ECDSA SigGen (FIPS186- 5) #2 KAT CAST On Demand Manually ECDSA SigVer (FIPS186- 5) #2 KAT CAST On Demand Manually ECDSA SigVer (Legacy) KAT CAST On Demand Manually RSA SigGen (FIPS186-5) KAT CAST On Demand Manually RSA SigVer (FIPS186-5) KAT CAST On Demand Manually RSA SigVer (Legacy) KAT CAST On Demand Manually Counter DRBG KAT CAST On Demand Manually Hash DRBG KAT CAST On Demand Manually FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 45 of 51 Algorithm or Test Test Method Test Type Period Periodic Method HMAC DRBG KAT CAST On Demand Manually SHA2-512 KAT CAST On Demand Manually SHA3-256 KAT CAST On Demand Manually HMAC-SHA2-256 KAT CAST On Demand Manually KAS-ECC-SSC Sp800- 56Ar3 KAT CAST On Demand Manually KAS-FFC-SSC Sp800- 56Ar3 KAT CAST On Demand Manually PBKDF KAT CAST On Demand Manually KTS-IFC KAT CAST On Demand Manually TLS v1.2 KDF RFC7627 KAT CAST On Demand Manually TLS v1.3 KDF KAT CAST On Demand Manually KDF SRTP KAT CAST On Demand Manually ECDSA KeyGen (FIPS186-5) PCT PCT RSA KeyGen (FIPS186-5) PCT PCT DSA KeyGen (FIPS186-4) PCT PCT Safe Primes Key Generation PCT PCT Table 20: Conditional Periodic Information 10.4 Error States The table below specifies the module’s error state information. Name Description Conditions Recovery Method Indicator Critical Error When the module enters this error state, the module inhibits all data output When the module fails the power-up integrity test, KATs, or conditional PCTs To recover from the Critical Error state, please power cycle the module. If the error persists after power cycling, the operator should contact Stryker Corporation for assistance EVP_get_error() returns PROV_R_FIPS_MODULE_IN_ERROR_STATE Table 21: Error States If the module continues to experience self-test failures after reinitializing, then the module will not be able to resume normal operations, and the CO should contact Stryker Corporation for assistance. 10.5 Operator Initiation of Self-Tests The CO can initiate the pre-operational self-tests and conditional CASTs on demand by re-instantiating the module or issuing the OSSL_PROVIDER_self_test() API command. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 46 of 51 11. Life-Cycle Assurance 11.1 Installation, Initialization, and Startup Procedures The Stryker Badge Cryptographic Module is not delivered to end-users as a standalone offering. Rather, it is a pre- built, integrated component of the Stryker badge application firmware, and these applications are the sole consumers of the cryptographic services provided by the module. The badge application firmware is delivered pre-installed on Stryker Badges. Stryker does not provide end-users with any mechanisms to directly access the module, its source code, its APIs, or any information sent to/from the module. There are no end-user procedures for module startup, and the application firmware starts when power is applied to the badge. The module’s integrity check is performed automatically at module startup (i.e., when the module is loaded into memory for execution) without action from the module operator, and end-users have no ability to bypass the automatic integrity check. No setup steps are required to be performed by end-users. 11.2 Administrator Guidance The OSSL_PROVIDER_get_params() API provides access to the current status of the module, as well as the name and version. • The OSSL_PROVIDER_get_params() API can be used to determine the module’s operational status. A return value of ‘1’ indicates that the module has passed all pre-operational self-tests and is currently in its Approved mode; a return value of ‘0’ indicates an error. • The OSSL_PROVIDER_get_params() API can be used to obtain the module’s versioning information. The API takes in OSSL_PARAM structure as an argument. This structure contains the “key” variable, which corresponds with the name of the parameter. If the OSSL_PARAM structure’s “key” variable is “name”, the API will return the module name. If the OSSL_PARAM structure’s “key” variable is “version”, the API will return the module version. Both values can be correlated with the module’s validation record. The expected output of OSSL_PROVIDER_get_params() when the “key” variable is “name” is Stryker Badge Cryptographic Module; the expected output of OSSL_PROVIDER_get_params() when the “key” variable is “version” is 3.4.0. The module is affected by CVE-2026-31790. To mitigate this vulnerability, the calling application must invoke EVP_PKEY_public_check() or EVP_PKEY_public_check_quick() to validate the public key before calling EVP_PKEY_encapsulate(). If any irregular activity is observed, or if the module is consistently reporting errors, then Stryker Customer Support should be contacted. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 47 of 51 11.3 Non-Administrator Guidance There is no specific guidance for module operators acting in a non-administrator capacity. 11.4 Design and Rules The module is a cryptographic library used by a calling application. The calling application is responsible for: • Use of the primitives in the correct sequence. • Use of keys in accordance with NIST SP 800‐140Drev2 (as the keys used by the module for cryptographic purposes are provided over the call stack by the calling application). • Use of a NIST SP 800‐90B compliant entropy source outside the module boundary with at least 256 bits of security strength. Entropy is supplied to the module via callback functions. The callback functions shall return an error if the minimum entropy strength cannot be met. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 48 of 51 12. Mitigation of Other Attacks 12.1 Attack List The Module implements mitigations for constant-time implementations and blinding attacks. 12.2 Mitigation Effectiveness Constant-time implementations protect cryptographic implementations in the Module against timing analysis since such attacks exploit differences in execution time depending on the cryptographic operation, and constant- time implementations ensure that the variations in execution time cannot be traced back to the key, CSP, or secret data. Numeric blinding protects the RSA, DSA and ECDSA algorithms from timing attacks. These algorithms are vulnerable to such attacks since attackers can measure the time of signature operations or RSA decryption. To mitigate this, the Module generates a random blinding factor which is provided as an input to the decryption/signature operation and is discarded once the operation has completed and resulted in an output. This makes it difficult for attackers to attempt timing attacks on such operations without the knowledge of the blinding factor, and therefore the execution time cannot be correlated to the RSA/DSA/ECDSA key. 12.3 Guidance and Constraints The mitigation mechanisms described in Section 12.2 are inherent within the validated algorithms. No other guidance or constraints are specified. FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 49 of 51 Appendix A. Acronyms and Abbreviations Table 22 provides definitions for the acronyms and abbreviations used in this document. Table 22: Acronyms and Abbreviations Term Definition AES Advanced Encryption Standard ANSI American National Standards Institute API Application Programming Interface CAST Cryptographic Algorithm Self-Test CBC Cipher Block Chaining CCCS Canadian Centre for Cyber Security CCM Counter with Cipher Block Chaining - Message Authentication Code CFB Cipher Feedback CKG Cryptographic Key Generation CMAC Cipher-Based Message Authentication Code CMVP Cryptographic Module Validation Program CO Cryptographic Officer CPU Central Processing Unit CSP Critical Security Parameter CTR Counter CVL Component Validation List DEP Default Entry Point DH Diffie-Hellman DRBG Deterministic Random Bit Generator DSA Digital Signature Algorithm ECB Electronic Code Book ECC Elliptic Curve Cryptography ECDH Elliptic Curve Diffie-Hellman ECDSA Elliptic Curve Digital Signature Algorithm FFC Finite Field Cryptography FIPS Federal Information Processing Standard GCM Galois/Counter Mode GMAC Galois Message Authentication Code HMAC (keyed-) Hash Message Authentication Code KAS Key Agreement Scheme FIPS 140-3 Non-Proprietary Security Policy, Version 1.0 June 8, 2026 Stryker Badge Cryptographic Module 3.4.0 ©2026 Stryker Corporation This document may be freely reproduced and distributed whole and intact including this copyright notice. Page 50 of 51 Term Definition KAT Known Answer Test KDF Key Derivation Function KTS Key Transport Scheme KW Key Wrap KWP Key Wrap with Padding NIST National Institute of Standards and Technology OCB Offset Codebook OFB Output Feedback OS Operating System PBKDF Password-Based Key Derivation Function PCT Pairwise Consistency Test PKCS Public Key Cryptography Standard PSS Probabilistic Signature Scheme PUB Publication RFC Request for Comment RNG Random Number Generator RSA Rivest Shamir Adleman SHA Secure Hash Algorithm SHAKE Secure Hash Algorithm KECCAK SHS Secure Hash Standard SRTP Secure Real-time Transport Protocol SP Special Publication TLS Transport Layer Security Prepared by: Corsec Security, Inc. 12600 Fair Lakes Circle, Suite 210 Fairfax, VA 22033 United States of America Phone: +1 703 267 6050 Email: info@corsec.com http://www.corsec.com