ICU Medical CE3.0 OpenSSL Cryptographic Module
ICU Medical CE3.0 OpenSSL Cryptographic Module, from ICU Medical, Inc., holds FIPS 140-2 certificate #4234 at overall level 1. The validation is historical: agencies may keep the module in existing systems but not buy it new. Below are its algorithm certificates, its validation history, and the list moves this tracker has observed, which NIST does not date.
Caveat: When operated in FIPS mode. No assurance of the minimum strength of generated keys
Certificate
| Certificate number | 4234 |
|---|---|
| Standard | FIPS 140-2 |
| Status | historical |
| Overall level | 1 |
| Module type | Software |
| Embodiment | Multi-Chip Stand Alone |
| Vendor | ICU Medical, Inc. · website |
| Software versions | 2.0.9.1 |
Module description
Quoted from the NIST CMVP entry for this certificate.
ICU Medical CE3.0 OpenSSL Cryptographic Module 2.0.9.1 is used within various ICU Medical Plum360 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 (10)
| Algorithm | CAVP certificates |
|---|---|
| AES | A1878 |
| CKG | vendor affirmed |
| CVL | A1878 |
| DRBG | A1878 |
| ECDSA | A1878 |
| HMAC | A1878 |
| KAS | |
| KAS-SSC | A1878 |
| RSA | A1878 |
| SHS | A1878 |
Tested configurations
- Android 2.3.7 running on ICU Medical Plum360 Infusion System with an i.MX53 Arm Cortex-A8 (single user mode)
Validation history
| Date | Type | Lab |
|---|---|---|
| 2022-05-24 | Initial | 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 at the time of the earliest snapshot
- 2026-09-22: observed moving from active to historical
- Validation dates on record: 2022-05-24