LifeCare PCA™ Infusion Pump

Certificate #4573

Webpage information

Status historical
Historical reason Moved to historical list due to sunsetting
Validation dates 31.08.2023
Standard FIPS 140-2
Security level 1
Type Hardware
Embodiment Multi-Chip Stand Alone
Caveat When operated in FIPS mode
Exceptions
  • Cryptographic Module Specification: Level 3
  • Roles, Services, and Authentication: Level 3
  • Mitigation of Other Attacks: N/A
Description LifeCare PCA™ is a Patient-Controlled Analgesia Infusion System with Full IV-EHR Interoperability.With the ICU Medical LifeCare PCA patient-controlled analgesia infusion system, you can be confident you are safely delivering the right drug at the right dose to the right patient in the right concentration. As the first and only PCA system with an integrated barcode reader and full IV-EHR interoperability, LifeCare PCA offers streamlined programming.
Version (Hardware) P/Ns 20837-04-07 and 20837-04-08 with components 810-04505-039 and 810-11438-018
Version (Firmware) CE v1.90.1.4 and MCU v7.4.1.3
Vendor ICU Medical, Inc.
References

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

Security policy

Security target PDF TXT

Symmetric Algorithms
AES, AES-128, AES-256, AES-192, Triple-DES, TDEA, HMAC, HMAC-SHA-384, HMAC-SHA-256
Asymmetric Algorithms
RSA 2048, ECDHE, ECDH, ECDSA, DH, Diffie-Hellman, DSA
Hash functions
SHA-1, SHA-512, SHA-256, SHA-384, SHA256, SHA-224
Schemes
Key Exchange, Key Agreement, AEAD
Protocols
SSL, TLS, TLS 1.2, TLS v1.2
Randomness
PRNG, DRBG, RNG
Libraries
OpenSSL
Elliptic Curves
P-224, P-256, P-384, P-521, curve P-224, P-512
Block cipher modes
ECB, CBC, GCM, XTS
TLS cipher suites
TLS_ECDHE_RSA_WITH_AES_256_GCM_SHA384

Standards
FIPS 140-2, FIPS140-2, FIPS PUB 140-2, SP 800-135, SP 800-90A, SP 800-56A

File metadata

Subject FIPS 140-2 Security Policy Template
Author Gerrit Kruitbosch
Creation date D:20220902114116-07'00'
Modification date D:20220902114142-07'00'
Pages 27
Creator Acrobat PDFMaker 22 for Word
Producer Adobe PDF Library 22.2.223

Heuristics

No heuristics are available for this certificate.

References

No references are available for this certificate.

Updates

  • The certificate data changed.
  • The certificate data changed.
  • The certificate was first processed.

Raw data 

{
  "_type": "sec_certs.sample.fips.FIPSCertificate",
  "cert_id": 4573,
  "dgst": "f3a6399711da0b03",
  "heuristics": {
    "_type": "sec_certs.sample.fips.FIPSCertificate.Heuristics",
    "algorithms": {
      "_type": "Set",
      "elements": [
        "AES#A2736",
        "KAS#A2736",
        "RSA#A2736",
        "CVL#A2736",
        "SHS#A2736",
        "DRBG#A2737",
        "HMAC#A2736",
        "ECDSA#A2736",
        "KTS#A2736"
      ]
    },
    "cpe_matches": null,
    "direct_transitive_cves": null,
    "extracted_versions": {
      "_type": "Set",
      "elements": [
        "7.4.1.3",
        "1.90.1.4"
      ]
    },
    "indirect_transitive_cves": null,
    "module_processed_references": {
      "_type": "sec_certs.sample.certificate.References",
      "directly_referenced_by": null,
      "directly_referencing": null,
      "indirectly_referenced_by": null,
      "indirectly_referencing": null
    },
    "module_prunned_references": {
      "_type": "Set",
      "elements": []
    },
    "policy_processed_references": {
      "_type": "sec_certs.sample.certificate.References",
      "directly_referenced_by": null,
      "directly_referencing": null,
      "indirectly_referenced_by": null,
      "indirectly_referencing": null
    },
    "policy_prunned_references": {
      "_type": "Set",
      "elements": []
    },
    "related_cves": null,
    "verified_cpe_matches": null
  },
  "pdf_data": {
    "_type": "sec_certs.sample.fips.FIPSCertificate.PdfData",
    "keywords": {
      "asymmetric_crypto": {
        "ECC": {
          "ECDH": {
            "ECDH": 14,
            "ECDHE": 13
          },
          "ECDSA": {
            "ECDSA": 22
          }
        },
        "FF": {
          "DH": {
            "DH": 1,
            "Diffie-Hellman": 5
          },
          "DSA": {
            "DSA": 1
          }
        },
        "RSA": {
          "RSA 2048": 3
        }
      },
      "certification_process": {},
      "cipher_mode": {
        "CBC": {
          "CBC": 19
        },
        "ECB": {
          "ECB": 2
        },
        "GCM": {
          "GCM": 20
        },
        "XTS": {
          "XTS": 1
        }
      },
      "cplc_data": {},
      "crypto_engine": {},
      "crypto_library": {
        "OpenSSL": {
          "OpenSSL": 4
        }
      },
      "crypto_protocol": {
        "TLS": {
          "SSL": {
            "SSL": 1
          },
          "TLS": {
            "TLS": 41,
            "TLS 1.2": 1,
            "TLS v1.2": 24
          }
        }
      },
      "crypto_scheme": {
        "AEAD": {
          "AEAD": 9
        },
        "KA": {
          "Key Agreement": 3
        },
        "KEX": {
          "Key Exchange": 4
        }
      },
      "device_model": {},
      "ecc_curve": {
        "NIST": {
          "P-224": 27,
          "P-256": 24,
          "P-384": 24,
          "P-512": 1,
          "P-521": 22,
          "curve P-224": 1
        }
      },
      "eval_facility": {},
      "fips_cert_id": {},
      "fips_certlike": {
        "Certlike": {
          "AES 128": 2,
          "AES 256": 1,
          "AES [197": 1,
          "AES-128": 14,
          "AES-192": 1,
          "AES-256": 14,
          "HMAC - SHA-224": 1,
          "HMAC SHA-(1": 1,
          "HMAC [198": 1,
          "HMAC-SHA-1": 16,
          "HMAC-SHA-1, 256": 2,
          "HMAC-SHA-256": 8,
          "HMAC-SHA-384": 8,
          "HMAC-SHA1": 2,
          "RSA 2048": 3,
          "SHA- 1": 1,
          "SHA-(1": 5,
          "SHA-(256": 11,
          "SHA-1": 6,
          "SHA-224": 1,
          "SHA-256": 10,
          "SHA-384": 5,
          "SHA-512": 4,
          "SHA256": 1,
          "SHS [180": 1
        }
      },
      "fips_security_level": {},
      "hash_function": {
        "SHA": {
          "SHA1": {
            "SHA-1": 6
          },
          "SHA2": {
            "SHA-224": 1,
            "SHA-256": 11,
            "SHA-384": 4,
            "SHA-512": 5,
            "SHA256": 1
          }
        }
      },
      "ic_data_group": {},
      "javacard_api_const": {},
      "javacard_packages": {},
      "javacard_version": {},
      "os_name": {},
      "pq_crypto": {},
      "randomness": {
        "PRNG": {
          "DRBG": 9,
          "PRNG": 1
        },
        "RNG": {
          "RNG": 1
        }
      },
      "side_channel_analysis": {},
      "standard_id": {
        "FIPS": {
          "FIPS 140-2": 38,
          "FIPS PUB 140-2": 1,
          "FIPS140-2": 1
        },
        "NIST": {
          "SP 800-135": 1,
          "SP 800-56A": 1,
          "SP 800-90A": 2
        }
      },
      "symmetric_crypto": {
        "AES_competition": {
          "AES": {
            "AES": 18,
            "AES-128": 14,
            "AES-192": 1,
            "AES-256": 14
          }
        },
        "DES": {
          "3DES": {
            "TDEA": 1,
            "Triple-DES": 4
          }
        },
        "constructions": {
          "MAC": {
            "HMAC": 7,
            "HMAC-SHA-256": 4,
            "HMAC-SHA-384": 4
          }
        }
      },
      "tee_name": {},
      "tls_cipher_suite": {
        "TLS": {
          "TLS_ECDHE_RSA_WITH_AES_256_GCM_SHA384": 1
        }
      },
      "vendor": {},
      "vulnerability": {}
    },
    "policy_metadata": {
      "/Author": "Gerrit Kruitbosch",
      "/Comments": "",
      "/Company": "Microsoft",
      "/CreationDate": "D:20220902114116-07\u002700\u0027",
      "/Creator": "Acrobat PDFMaker 22 for Word",
      "/Keywords": "",
      "/ModDate": "D:20220902114142-07\u002700\u0027",
      "/Producer": "Adobe PDF Library 22.2.223",
      "/SourceModified": "D:20220902184058",
      "/Subject": "FIPS 140-2 Security Policy Template",
      "/Title": "",
      "pdf_file_size_bytes": 652408,
      "pdf_hyperlinks": {
        "_type": "Set",
        "elements": []
      },
      "pdf_is_encrypted": false,
      "pdf_number_of_pages": 27
    }
  },
  "state": {
    "_type": "sec_certs.sample.fips.FIPSCertificate.InternalState",
    "module_download_ok": true,
    "module_extract_ok": true,
    "policy_convert_ok": true,
    "policy_download_ok": true,
    "policy_extract_ok": true,
    "policy_json_hash": null,
    "policy_pdf_hash": "71bdea63b6d768c4a190233de53f5c53b448191ac05c63be465fcdc4b2213529",
    "policy_txt_hash": "719e8e04071037c1b8399d6010cc694a3f9f9e57d09a3ed3dd00d4a424be43bb"
  },
  "web_data": {
    "_type": "sec_certs.sample.fips.FIPSCertificate.WebData",
    "caveat": "When operated in FIPS mode",
    "certificate_pdf_url": "https://csrc.nist.gov/CSRC/media/projects/cryptographic-module-validation-program/documents/certificates/August 2023_010923_0844.pdf",
    "date_sunset": null,
    "description": "LifeCare PCA\u2122 is a Patient-Controlled Analgesia Infusion System with Full IV-EHR Interoperability.With the ICU Medical LifeCare PCA patient-controlled analgesia infusion system, you can be confident you are safely delivering the right drug at the right dose to the right patient in the right concentration. As the first and only PCA system with an integrated barcode reader and full IV-EHR interoperability, LifeCare PCA offers streamlined programming.",
    "embodiment": "Multi-Chip Stand Alone",
    "exceptions": [
      "Cryptographic Module Specification: Level 3",
      "Roles, Services, and Authentication: Level 3",
      "Mitigation of Other Attacks: N/A"
    ],
    "fw_versions": "CE v1.90.1.4 and MCU v7.4.1.3",
    "historical_reason": "Moved to historical list due to sunsetting",
    "hw_versions": "P/Ns 20837-04-07 and 20837-04-08 with components 810-04505-039 and 810-11438-018",
    "level": 1,
    "mentioned_certs": {},
    "module_name": "LifeCare PCA\u2122 Infusion Pump",
    "module_type": "Hardware",
    "revoked_link": null,
    "revoked_reason": null,
    "standard": "FIPS 140-2",
    "status": "historical",
    "sw_versions": null,
    "tested_conf": null,
    "validation_history": [
      {
        "_type": "sec_certs.sample.fips.FIPSCertificate.ValidationHistoryEntry",
        "date": "2023-08-31",
        "lab": "UL Verification Services, Inc.",
        "validation_type": "Initial"
      }
    ],
    "vendor": "ICU Medical, Inc.",
    "vendor_url": "http://www.icumed.com/"
  }
}