LifeCare PCA™ Infusion Pump
Caveat: When operated in FIPS mode
Certificate
| Certificate number | 4573 |
|---|---|
| Standard | FIPS 140-2 |
| Status | historical |
| Overall level | 1 |
| Module type | Hardware |
| Embodiment | Multi-Chip Stand Alone |
| Vendor | ICU Medical, Inc. · website |
| Hardware versions | P/Ns 20837-04-07 and 20837-04-08 with components 810-04505-039 and 810-11438-018 |
| Firmware versions | CE v1.90.1.4 and MCU v7.4.1.3 |
Module 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.
Security level exceptions
- Cryptographic Module Specification: Level 3
- Roles, Services, and Authentication: Level 3
- Mitigation of Other Attacks: N/A
Approved algorithms
| Algorithm | CAVP certificate |
|---|---|
| AES | A2736 |
| CKG | vendor affirmed |
| CVL | A2736 |
| DRBG | A2737 |
| ECDSA | A2736 |
| HMAC | A2736 |
| KAS | |
| KTS | |
| KTS | |
| RSA | A2736 |
| SHS | A2736 |
Allowed algorithms
NDRNG
Tested configurations
- N/A
Validation history
| Date | Type | Lab |
|---|---|---|
| 2023-08-31 | 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
- Validation dates on record: 2023-08-31