808bits

ICU Medical CE3.0 OpenSSL Cryptographic Module

FIPS 140-2 certificate #2805 · ICU Medical, Inc. · data as of 2026-10-21

ICU Medical CE3.0 OpenSSL Cryptographic Module, from ICU Medical, Inc., holds FIPS 140-2 certificate #2805 at overall level 1. The validation is historical: agencies may keep the module in existing systems but not buy it new. Below are its validation history, algorithm certificates and security policy, drawn from the NIST CMVP entry.

Historical. Moved to historical list due to sunsetting. Federal agencies may reference historical validations for existing systems only, not for new procurement.
Caveat: When operated in FIPS mode. No assurance of the minimum strength of generated keys. The module generates cryptographic keys whose strengths are modified by available entropy.

Certificate

Certificate number2805
StandardFIPS 140-2
Statushistorical
Overall level1
Module typeSoftware
EmbodimentMulti-Chip Stand Alone
VendorICU Medical, Inc. · website
Software versions2.0.9

Module description

Quoted from the NIST CMVP entry for this certificate.

ICU Medical CE3.0 OpenSSL Cryptographic Module 2.0.9 is used within various ICU Medical Infusion Pumps for providing secure communication between Infusion pumps and external server.

Security level exceptions

  • Physical Security: N/A
  • Mitigation of Other Attacks: N/A

Approved algorithms (9)

AlgorithmCAVP certificates
AES3930
CVL781
DRBG1139
DSA1073
ECDSA860
HMAC2553
RSA2007
SHS3240
Triple-DES2157

Other algorithms

EC Diffie-Hellman (CVL Cert. #781, key agreement, key establishment methodology provides between 112 and 256 bit of encryption strength; non-compliant less than 112 bits of encryption strength); RSA (key wrapping; key establishment methodology provides between 112 and 270 bits of encryption strength; non-compliant less than 112 bits of encryption strength); Dual EC DRBG; RNG

Tested configurations

  • Android 2.3.7 running on ICUMedical Plum360 Infusion System with an i.MX53 Arm Cortex-A8 (single user mode)

Validation history

DateTypeLab
2016-12-13InitialUL Verification Services, Inc.
2020-07-23UpdateUL Verification Services, Inc.
2021-04-14UpdateUL Verification Services, Inc.

Status timeline

As observed by this tracker's snapshots. NIST publishes no dates for list moves; observation began 2026-08-21, so earlier changes carry no date.

  • 2026-08-21: first observed by this tracker, status historical
  • Validation dates on record: 2016-12-13, 2020-07-23, 2021-04-14

Source documents