ICU Medical CE3.0 OpenSSL Cryptographic Module
Caveat: When operated in FIPS mode. No assurance of the minimum strength of generated keys
Certificate
| Certificate number | 4234 |
|---|---|
| Standard | FIPS 140-2 |
| Status | active |
| Sunset date | 2026-09-21 |
| Overall level | 1 |
| Module type | Software |
| Embodiment | Multi-Chip Stand Alone |
| Vendor | ICU Medical, Inc. · website |
| Software versions | 2.0.9.1 |
Module description
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
| Algorithm | CAVP certificate |
|---|---|
| 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 active
- Validation dates on record: 2022-05-24