ICU Medical FIPS Module for OpenSSL 3

Certificate details

Certificate ID #5073
Status active
Validation dates 26.09.2025 , 26.11.2025 , 02.04.2026
Sunset date 10-07-2029
Standard FIPS 140-3
Security level 1
Type Software
Embodiment Multi-Chip Stand Alone
Caveat No assurance of the minimum strength of generated SSPs (e.g., keys).
Exceptions
  • Physical security: N/A
  • Non-invasive security: N/A
  • Life-cycle assurance: Level 3
Description The ICU Medical FIPS Module for OpenSSL is a general-purpose cryptographic module integrated in ICU Medical products (Plum Solo, Plum Duo, Plum 360, Medfusion 5000, CADD Solis) to provide FIPS 140-3 validated cryptography for the protection of sensitive information.
Vendor ICU Medical http://www.icumed.com
Lab Acumen Security
References

This certificate's webpage directly references 0 certificates, transitively this expands into 0 certificates.

Security policy

Extracted keywords

Symmetric Algorithms
AES-128, AES-192, AES-256, AES, CAST, HMAC, KMAC, CMAC
Asymmetric Algorithms
ECDSA, EdDSA, ECC, DHE, DSA
Hash functions
SHA-1, SHA2, SHA3-224, SHA3-256, SHA3-384, SHA3-512, SHA-3, SHA3, SHAKE128, SHAKE256, PBKDF
Schemes
MAC, Key agreement, Key Agreement, AEAD
Protocols
SSH, SSHv2, TLS v1.2, TLS v1.3, TLS 1.3, TLS, TLS 1.2
Randomness
DRBG, RBG
Libraries
OpenSSL
Elliptic Curves
P-224, P-256, P-384, P-521, P-192, B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, B-163, K-163
Block cipher modes
CTR, GCM, CCM

JavaCard API constants
ED25519, ED448
Trusted Execution Environments
PSP, SSC
Vendor
NXP

Security level
Level 1
Side-channel analysis
timing attacks

Automated analysis

Automated inference - use with caution

All attributes shown in this section (e.g., links between certificates, products, vendors, and known CVEs) are generated by automated heuristics and have not been reviewed by humans. These methods can produce false positives or false negatives and should not be treated as definitive without independent verification. This applies equally to the Cross-references section below. If you want to know more about how this data is computed and how reliable it is, see our documentation on automated analysis. If you believe any information here is inaccurate or harmful, please submit feedback.

No automatically derived data are available in this section.

Cross-references

No references are available for this certificate.

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Raw data

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  "cert_id": 5073,
  "dgst": "159ea0a601d6576a",
  "heuristics": {
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    "cpe_matches": null,
    "direct_transitive_cves": null,
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    "module_prunned_references": {
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    "policy_prunned_references": {
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    "related_cves": null,
    "verified_cpe_matches": null
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  "pdf_data": {
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    "keywords": {
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          "ECDSA": {
            "ECDSA": 23
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          "EdDSA": {
            "EdDSA": 4
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        "FF": {
          "DH": {
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          "DSA": {
            "DSA": 23
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      "certification_process": {},
      "cipher_mode": {
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        "CTR": {
          "CTR": 3
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        "GCM": {
          "GCM": 3
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      },
      "cplc_data": {},
      "crypto_engine": {},
      "crypto_library": {
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          "SSHv2": 2
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        "TLS": {
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            "TLS 1.2": 1,
            "TLS 1.3": 1,
            "TLS v1.2": 4,
            "TLS v1.3": 5
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        "KA": {
          "Key Agreement": 1,
          "Key agreement": 14
        },
        "MAC": {
          "MAC": 36
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      },
      "device_model": {},
      "ecc_curve": {
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          "B-409": 14,
          "B-571": 14,
          "K-163": 4,
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          "K-283": 14,
          "K-409": 14,
          "K-571": 14,
          "P-192": 8,
          "P-224": 32,
          "P-256": 30,
          "P-384": 28,
          "P-521": 28
        }
      },
      "eval_facility": {},
      "fips_cert_id": {},
      "fips_certlike": {
        "Certlike": {
          "AES-128": 7,
          "AES-192": 6,
          "AES-256": 6,
          "HMAC-SHA-1": 6,
          "PKCS 1": 4,
          "SHA-1": 15,
          "SHA-3": 3,
          "SHA2": 1,
          "SHA2- 256": 2,
          "SHA2-224": 19,
          "SHA2-256": 25,
          "SHA2-384": 20,
          "SHA2-512": 24,
          "SHA3": 1,
          "SHA3-224": 5,
          "SHA3-256": 9,
          "SHA3-384": 5,
          "SHA3-512": 8
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      "fips_security_level": {
        "Level": {
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      "hash_function": {
        "PBKDF": {
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        },
        "SHA": {
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            "SHA-1": 15
          },
          "SHA2": {
            "SHA2": 1
          },
          "SHA3": {
            "SHA-3": 3,
            "SHA3": 1,
            "SHA3-224": 5,
            "SHA3-256": 9,
            "SHA3-384": 5,
            "SHA3-512": 8
          }
        },
        "SHAKE": {
          "SHAKE128": 1,
          "SHAKE256": 1
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      },
      "ic_data_group": {},
      "javacard_api_const": {
        "curves": {
          "ED25519": 4,
          "ED448": 4
        }
      },
      "javacard_packages": {},
      "javacard_version": {},
      "os_name": {},
      "pq_crypto": {},
      "randomness": {
        "PRNG": {
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        },
        "RNG": {
          "RBG": 3
        }
      },
      "side_channel_analysis": {
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        }
      },
      "standard_id": {
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          "FIPS 180-4": 7,
          "FIPS 186-4": 13,
          "FIPS 186-5": 6,
          "FIPS 198-1": 11,
          "FIPS 202": 6,
          "FIPS186-4": 39,
          "FIPS186-5": 4
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        "ISO": {
          "ISO/IEC 19790:2012": 3
        },
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          "SP 800-108": 2,
          "SP 800-132": 7,
          "SP 800-133": 7,
          "SP 800-135": 9,
          "SP 800-140D": 1,
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          "SP 800-38B": 1,
          "SP 800-38C": 1,
          "SP 800-38D": 4,
          "SP 800-38E": 2,
          "SP 800-38F": 3,
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          "SP 800-56B": 8,
          "SP 800-56C": 7,
          "SP 800-57": 5,
          "SP 800-90A": 5,
          "SP 800-90B": 2
        },
        "PKCS": {
          "PKCS 1": 2
        },
        "RFC": {
          "RFC 5288": 1,
          "RFC 5647": 1,
          "RFC 8446": 1,
          "RFC7627": 3,
          "RFC8446": 1
        }
      },
      "symmetric_crypto": {
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            "AES-128": 7,
            "AES-192": 6,
            "AES-256": 6
          },
          "CAST": {
            "CAST": 73
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        "constructions": {
          "MAC": {
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            "HMAC": 20,
            "KMAC": 7
          }
        }
      },
      "tee_name": {
        "AMD": {
          "PSP": 12
        },
        "IBM": {
          "SSC": 1
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      },
      "tls_cipher_suite": {},
      "vendor": {
        "NXP": {
          "NXP": 3
        }
      },
      "vulnerability": {}
    },
    "policy_metadata": {
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      "/Comments": "",
      "/Company": "",
      "/ComplianceAssetId": "",
      "/ContentTypeId": "0x010100DCA90304BC368747933546DC38C49DF0",
      "/CreationDate": "D:20260331093023-04\u002700\u0027",
      "/Creator": "Acrobat PDFMaker 25 for Word",
      "/Keywords": "",
      "/MediaServiceImageTags": "",
      "/ModDate": "D:20260331093445-04\u002700\u0027",
      "/Order": "1084700.000000",
      "/Producer": "Adobe PDF Library 25.1.40",
      "/SourceModified": "",
      "/Subject": "",
      "/TemplateUrl": "",
      "/Title": "",
      "/TriggerFlowInfo": "",
      "/_ExtendedDescription": "",
      "/xd_ProgID": "",
      "/xd_Signature": "0",
      "pdf_file_size_bytes": 747568,
      "pdf_hyperlinks": {
        "_type": "Set",
        "elements": [
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      },
      "pdf_is_encrypted": false,
      "pdf_number_of_pages": 43
    }
  },
  "state": {
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    "module": {
      "_type": "sec_certs.sample.document_state.DocumentState",
      "convert_ok": true,
      "download_ok": true,
      "extract_ok": true,
      "json_hash": null,
      "source_hash": null,
      "txt_hash": null
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    "policy": {
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  "web_data": {
    "_type": "sec_certs.sample.fips.FIPSCertificate.WebData",
    "caveat": "No assurance of the minimum strength of generated SSPs (e.g., keys).",
    "certificate_pdf_url": "https://csrc.nist.gov/CSRC/media/projects/cryptographic-module-validation-program/documents/certificates/November 2025_181225_1202.pdf",
    "date_sunset": "2029-07-10",
    "description": "The ICU Medical FIPS Module for OpenSSL is a general-purpose cryptographic module integrated in ICU Medical products (Plum Solo, Plum Duo, Plum 360, Medfusion 5000, CADD Solis) to provide FIPS 140-3 validated cryptography for the protection of sensitive information.",
    "embodiment": "Multi-Chip Stand Alone",
    "exceptions": [
      "Physical security: N/A",
      "Non-invasive security: N/A",
      "Life-cycle assurance: Level 3"
    ],
    "fw_versions": null,
    "historical_reason": null,
    "hw_versions": null,
    "level": 1,
    "mentioned_certs": {},
    "module_name": "ICU Medical FIPS Module for OpenSSL 3",
    "module_type": "Software",
    "revoked_link": null,
    "revoked_reason": null,
    "standard": "FIPS 140-3",
    "status": "active",
    "sw_versions": null,
    "tested_conf": null,
    "validation_history": [
      {
        "_type": "sec_certs.sample.fips.FIPSCertificate.ValidationHistoryEntry",
        "date": "2025-09-26",
        "lab": "Acumen Security",
        "validation_type": "Initial"
      },
      {
        "_type": "sec_certs.sample.fips.FIPSCertificate.ValidationHistoryEntry",
        "date": "2025-11-26",
        "lab": "Acumen Security",
        "validation_type": "Update"
      },
      {
        "_type": "sec_certs.sample.fips.FIPSCertificate.ValidationHistoryEntry",
        "date": "2026-04-02",
        "lab": "Acumen Security",
        "validation_type": "Update"
      }
    ],
    "vendor": "ICU Medical",
    "vendor_url": "http://www.icumed.com"
  }
}