ICU Medical CE3.0 OpenSSL Cryptographic Module
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 number | 2805 |
|---|---|
| Standard | FIPS 140-2 |
| Status | historical |
| Overall level | 1 |
| Module type | Software |
| Embodiment | Multi-Chip Stand Alone |
| Vendor | ICU Medical, Inc. · website |
| Software versions | 2.0.9 |
Module description
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
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
| Date | Type | Lab |
|---|---|---|
| 2016-12-13 | Initial | UL Verification Services, Inc. |
| 2020-07-23 | Update | UL Verification Services, Inc. |
| 2021-04-14 | Update | UL 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