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Cryptographic Module Validation Program CMVP

Certificate #3340


Module Name
SapphirePlus OpenSSL Cryptographic Module
FIPS 140-2
 Historical Reason
186-2 transition
Overall Level
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.
Security Level Exceptions
  • Roles, Services, and Authentication: Level 2
  • Physical Security: N/A
  • Mitigation of Other Attacks: N/A
Module Type
Multi-Chip Stand Alone
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.
Tested Configuration(s)
  • Custom Linux 2.6.35 running on SapphirePlus Infusion System with NXP-i.MX280-ARM (single user mode)
Approved Algorithms
AES Cert. #5643
CVL Cert. #2038
DRBG Cert. #2276
DSA Cert. #1445
ECDSA Cert. #1521
HMAC Cert. #3758
RSA Cert. #3035
SHS Cert. #4525
Triple-DES Cert. #2832
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)
Software Versions


Q Core Medical Ltd.
Yad Harutzim 29
Netanya 4250529

Nimrod Schweitzer
Phone: 972.73.2388839
Fax: 972.73.2388800

Validation History

Date Type Lab