808bits

SapphirePlus OpenSSL Cryptographic Module

FIPS 140-2 certificate #3340 · Q Core Medical Ltd. · data as of 2026-10-09

SapphirePlus OpenSSL Cryptographic Module, from Q Core Medical Ltd., holds FIPS 140-2 certificate #3340 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. 186-2 transition. Federal agencies may reference historical validations for existing systems only, not for new procurement.
Caveat: When built, installed, protected and initialized as assumed by the Crypto Officer role and as specified in the provided Security Policy and operated in FIPS mode. Appendix A of the provided Security Policy specifies the actual distribution tar file containing the source code of this module. There shall be no additions, deletions or alterations to the tar file contents as used during module build. The distribution tar file shall be verified as specified in Appendix A of the provided Security Policy. Installation and protection shall be completed as specified in Appendix A of the provided Security Policy. Initialization shall be invoked as per Section 4 of the provided Security Policy. Any deviation from specified verification, protection, installation and initialization procedures will result in a non FIPS 140-2 compliant module. No assurance of the minimum strength of generated keys.

Certificate

Certificate number3340
StandardFIPS 140-2
Statushistorical
Overall level1
Module typeSoftware
EmbodimentMulti-Chip Stand Alone
VendorQ Core Medical Ltd. · website
Software versions2.0.9

Module description

Quoted from the NIST CMVP entry for this certificate.

The SapphirePlus infusion system provides a targeted solution for the Hospira MedNet users in the hospital market, offering the outstanding performance, ease of use and reliability of the entire Sapphire product family, with special concern for the clinical and ambulatory environments, as well as the pre-hospital medical ground transportation. With Q Core’s advanced software version implemented, the SapphirePlus pump offers a complete integration of the Sapphire infusion pump with Hospira MedNet system, used in hospitals across the US.

Security level exceptions

  • Roles, Services, and Authentication: Level 2
  • Physical Security: N/A
  • Mitigation of Other Attacks: N/A

Approved algorithms (9)

AlgorithmCAVP certificates
AES5643
CVL2038
DRBG2276
DSA1445
ECDSA1521
HMAC3758
RSA3035
SHS4525
Triple-DES2832

Allowed algorithms

EC Diffie-Hellman (key agreement; key establishment methodology provides between 112 and 256 bits of encryption strength); RSA (key wrapping; key establishment methodology provides between 112 and 256 bits of encryption strength)

Tested configurations

  • Custom Linux 2.6.35 running on SapphirePlus Infusion System with NXP-i.MX280-ARM (single user mode)

Validation history

DateTypeLab
2018-12-14InitialUL 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: 2018-12-14

Source documents