| Standard | FIPS 140-3 |
|---|---|
| Overall level | 1 |
| Module type | Software |
| Embodiment | Multi-Chip Stand Alone |
| Status | Active |
| Sunset date | 7/10/2029 |
| Caveat | No assurance of the minimum strength of generated SSPs (e.g., keys). |
| Vendor | ICU Medical |
flowchart LR
%% Deterministic review-risk graph for ICU Medical FIPS Module for OpenSSL 3
%% Review prompts and evidence gaps, NOT vulnerability findings.
subgraph CMVP["CMVP-disclosed clues"]
C2["[low] Firmware update / recovery<br/>/ rollback (referenced in<br/>text)<br/><i>Recovery</i>"]
C3["[low] Self-test / status surface<br/>(referenced in text)<br/><i>Self-Test<br/>Unauth<br/>Status Output</i>"]
C5["[low] Protocol / secure-channel<br/>references (may be KDF<br/>names, not a live channel)<br/><i>TLS<br/>SSH<br/>DTLS</i>"]
C6["[low] Operating system / runtime<br/>referenced (boundary<br/>membership not asserted)<br/><i>operating system<br/>linux<br/>application</i>"]
end
subgraph Inference["Derived inference"]
I2["Possible only, trusted<br/>code is reachable through<br/>update and recovery paths."]
I3["Possible only, some<br/>services may process input<br/>before, or without,<br/>operator authentication."]
I5["Possible only, a protocol<br/>is referenced, but whether<br/>it is a live channel or<br/>only a KDF/algorithm name<br/>is unconfirmed."]
I6["Possible only, a<br/>runtime/OS is referenced,<br/>but its membership in the<br/>cryptographic boundary is<br/>not established."]
end
subgraph Risk["Reviewer question"]
R2["Are update images<br/>authenticated before<br/>parsing, and are<br/>downgrade/rollback paths<br/>constrained?"]
R3["Can unauthenticated<br/>services leak state,<br/>consume resources, or<br/>transition security state?"]
R5["If a live TLS/SSH/IKE<br/>channel exists, could<br/>library CVEs apply, or is<br/>this only a<br/>KDF/documentation name?"]
R6["If the OS/runtime is<br/>in-boundary, could its<br/>CVEs be hidden by<br/>firmware-only versioning?"]
end
subgraph Evidence["Evidence needed to close"]
E2["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>update image format ·<br/>signature-before-parse<br/>proof · anti-rollback /<br/>downgrade policy"]
E3["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>pre-auth reachability<br/>matrix · rate limits and<br/>output redaction ·<br/>abuse-case tests"]
E5["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>library identity and<br/>version ·<br/>certificate-validation<br/>behaviour · protocol-CVE<br/>disposition"]
E6["confirm the disclosure<br/>itself (keyword hit,<br/>context unverified) ·<br/>runtime identity and<br/>config · kernel/runtime<br/>hardening profile ·<br/>patch/backport manifest"]
end
C2 --> I2 --> R2 --> E2
C3 --> I3 --> R3 --> E3
C5 --> I5 --> R5 --> E5
C6 --> I6 --> R6 --> E6
classDef clue fill:#eef3f9,stroke:#6f7f91,color:#1f3a5f;
classDef infer fill:#fff7e6,stroke:#b98500,color:#6b4e00;
classDef risk fill:#fbe9e9,stroke:#b02a2a,color:#7a1f1f;
classDef evidence fill:#e6f4ea,stroke:#1e7d34,color:#14532d;
class C2,C3,C5,C6 clue;
class I2,I3,I5,I6 infer;
class R2,R3,R5,R6 risk;
class E2,E3,E5,E6 evidence;flowchart LR
%% Deterministic clue tier for ICU Medical FIPS Module for OpenSSL 3
%% confidence: high = structured record field; medium = structured but soft; low (dashed) = bare keyword hit, context unverified
subgraph CMVP["CMVP-disclosed clues (deterministic)"]
C2["[low] Firmware update / recovery / rollback (referenced in text)<br/><i>Recovery</i><br/>src: text:keyword"]
C3["[low] Self-test / status surface (referenced in text)<br/><i>Self-Test<br/>Unauth<br/>Status Output</i><br/>src: text:keyword"]
C5["[low] Protocol / secure-channel references (may be KDF names, not a live channel)<br/><i>TLS<br/>SSH<br/>DTLS</i><br/>src: text:keyword"]
C6["[low] Operating system / runtime referenced (boundary membership not asserted)<br/><i>operating system<br/>linux<br/>application</i><br/>src: text:keyword"]
end
classDef clueHigh fill:#eef3f9,stroke:#2f6fb0,stroke-width:2px,color:#1f3a5f;
classDef clueMedium fill:#eef3f9,stroke:#6f7f91,color:#1f3a5f;
classDef clueLow fill:#f7f7f7,stroke:#999,stroke-dasharray:4 4,color:#444;
class C2,C3,C5,C6 clueLow;ICU Medical ICU Medical FIPS Module for OpenSSL 3 Document Version 1.2 January 30, 2026 Prepared for: Prepared by: ICU Medical KeyPair Consulting Inc.
San Clemente, CA 92673 San Luis Obispo, CA 93401 icumed.com keypair.us +1 805.316.5024
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Table of Contents
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 List of Tables List of Figures
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
denoted the Module. The Module meets FIPS 140-3 overall Level 1 requirements, with security levels as shown in Section 1.2. In accordance with AS02.05, ISO/IEC 19790:2012 §7.7 Physical Security is optional and does not apply to the Module.
Section Title Security Level
Overall Level 1 Table 1: Security Levels
Purpose and Use: The Module is a cryptographic software library, intended for use by US and Canadian Federal agencies and other markets that require FIPS 140-3 validated cryptographic functionality. The Module design corresponds to the Module security rules. Security rules enforced by the Module are described in the appropriate context of this document. Module Type: Software Module Embodiment: Multi-Chip Standalone
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Cryptographic Boundary: Figure 1 depicts the Module operational environment, with the cryptographic boundary highlighted in red inclusive of all Module entry points (API calls). The Module is defined as a Software module per AS02.03. The pre-operational approved integrity test is performed over all components within the cryptographic boundary. Tested Operational Environment’s Physical Perimeter (TOEPP): The General Purpose Computer is the TOEPP. Figure 1: Block Diagram
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
Tested Module Identification
Modes List and Description: Mode Description Type Status Name Indicator Nominal Approved mode of operation Approved Table 5: Modes List and Description
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 The Module only supports an Approved mode of operation. The conditions for using the Module in the Approved mode of operation are:
Approved Algorithms: Algorithm CAVP Cert Properties Reference AES-CBC A7142 Direction - Decrypt, Encrypt SP 800-38A Key Length - 128, 192, 256 AES-CBC-CS1 A7142 Direction - decrypt, encrypt SP 800-38A Key Length - 128, 192, 256 Payload Length - Payload Length: 128-512 Increment 8 AES-CBC-CS2 A7142 Direction - decrypt, encrypt SP 800-38A Key Length - 128, 192, 256 Payload Length - Payload Length: 128-512 Increment 8 AES-CBC-CS3 A7142 Direction - decrypt, encrypt SP 800-38A Key Length - 128, 192, 256 Payload Length - Payload Length: 136-512 Increment 8 AES-CCM A7142 Key Length - 128, 192, 256 SP 800-38C Tag Length - 112, 128, 32, 48, 64, 80, 96 IV Length - IV Length: 56-104 Increment 8 Payload Length - Payload Length: 0-256 Increment 8 AAD Length - AAD Length: 0-524288 Increment 8
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference AES-CFB1 A7142 Direction - Decrypt, Encrypt SP 800-38A Key Length - 128, 192, 256 AES-CFB128 A7142 Direction - Decrypt, Encrypt SP 800-38A Key Length - 128, 192, 256 AES-CFB8 A7142 Direction - Decrypt, Encrypt SP 800-38A Key Length - 128, 192, 256 AES-CMAC A7142 Direction - Generation, Verification SP 800-38B Key Length - 128, 192, 256 MAC Length - MAC Length: 128 Message Length - Message Length: 0-524288 Increment 8 AES-CTR A7142 Direction - Decrypt, Encrypt SP 800-38A Key Length - 128, 192, 256 Payload Length - Payload Length: 8-128 Increment 8 Supports Counter larger than maximum value - No Incremental Counter - Yes Counter Tests Performed - Yes AES-ECB A7142 Direction - Decrypt, Encrypt SP 800-38A Key Length - 128, 192, 256 AES-GCM A7142 Direction - Decrypt, Encrypt SP 800-38D IV Generation - External, Internal IV Generation Mode - 8.2.1 Key Length - 128, 192, 256 Tag Length - 104, 112, 120, 128, 32, 64, 96 IV Length - IV Length: 96-1024 Increment 8 Payload Length - Payload Length: 8-65536 Increment 8 AAD Length - AAD Length: 0-65536 Increment 8 AES-GMAC A7142 Direction - Decrypt, Encrypt SP 800-38D IV Generation - External, Internal IV Generation Mode - 8.2.1 Key Length - 128, 192, 256 Tag Length - 104, 112, 120, 128, 32, 64, 96 IV Length - IV Length: 96 AAD Length - AAD Length: 0-65536 Increment 8 AES-KW A7142 Direction - Decrypt, Encrypt SP 800-38F Cipher - Cipher, Inverse Key Length - 128, 192, 256 Payload Length - Payload Length: 128-4096 Increment 128 AES-KWP A7142 Direction - Decrypt, Encrypt SP 800-38F Cipher - Cipher, Inverse
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference Key Length - 128, 192, 256 Payload Length - Payload Length: 8-4096 Increment 8 AES-OFB A7142 Direction - Decrypt, Encrypt SP 800-38A Key Length - 128, 192, 256 AES-XTS Testing Revision A7142 Direction - Decrypt, Encrypt SP 800-38E
Payload Length - Payload Length: 128-65536 Increment 128 Tweak Mode - Hex Data Unit Length Matches Payload Length - Yes Counter DRBG A7142 Prediction Resistance - Yes SP 800-90A Supports Reseed - Yes Rev. 1 Mode - AES-128, AES-192, AES-256 Derivation Function Enabled - No, Yes Additional Input - Additional Input: 0-256 Increment 256, Additional Input: 256, Additional Input: 320, Additional Input: 384 Entropy Input - Entropy Input: 128-256 Increment 128, Entropy Input: 256, Entropy Input: 256-512 Increment 128, Entropy Input: 320, Entropy Input: 384 Nonce - Nonce: 0, Nonce: 128 Personalization String Length - Personalization String Length: 0-256 Increment 256, Personalization String Length: 256, Personalization String Length: 320, Personalization String Length: 384 Returned Bits - 256 DSA KeyGen (FIPS186-4) A7142 L - 2048, 3072 FIPS 186-4 N - 224, 256 DSA PQGGen (FIPS186-4) A7142 P/Q Generation Methods - Probable FIPS 186-4 G Generation Methods - Canonical, Unverifiable L - 2048, 3072 N - 224, 256 Hash Algorithm - SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256 DSA PQGVer (FIPS186-4) A7142 P/Q Generation Methods - Probable FIPS 186-4 G Generation Methods - Canonical, Unverifiable L - 1024, 2048, 3072 N - 160, 224, 256 Hash Algorithm - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256 DSA SigGen (FIPS186-4) A7142 L - 2048, 3072 FIPS 186-4 N - 224, 256 Hash Algorithm - SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256 DSA SigVer (FIPS186-4) A7142 L - 1024, 2048, 3072 FIPS 186-4 N - 160, 224, 256 Hash Algorithm - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference ECDSA KeyGen (FIPS186- A7142 Curve - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-224, P-256, P-384, P-521 FIPS 186-4
Nonce - Nonce: 128-160 Increment 32, Nonce: 96-128 Increment 32 Personalization String Length - Personalization String Length: 0-256 Increment 128 Additional Input - Additional Input: 0-256 Increment 128 Returned Bits - 160, 224, 256, 384, 512 HMAC DRBG A7142 Prediction Resistance - Yes SP 800-90A Supports Reseed - Yes Rev. 1 Mode - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256 Entropy Input - Entropy Input: 160-256 Increment 32, Entropy Input: 192-256 Increment 64, Entropy Input: 256-
512 Increment 64, Entropy Input: 384-512 Increment 64, Entropy Input: 512-1024 Increment 64
Nonce - Nonce: 128, Nonce: 64, Nonce: 96 Personalization String Length - Personalization String Length: 0-192 Increment 64, Personalization String Length: 0-256 Increment 128 Additional Input - Additional Input: 0-256 Increment 128, Additional Input: 192 Returned Bits - 160, 224, 256, 384, 512 HMAC-SHA-1 A7142 MAC - MAC: 32-160 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference HMAC-SHA2-224 A7142 MAC - MAC: 32-224 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA2-256 A7142 MAC - MAC: 32-256 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA2-384 A7142 MAC - MAC: 32-384 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA2-512 A7142 MAC - MAC: 32-512 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA2-512/224 A7142 MAC - MAC: 32-224 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA2-512/256 A7142 MAC - MAC: 32-256 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA3-224 A7142 MAC - MAC: 32-224 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA3-256 A7142 MAC - MAC: 32-256 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA3-384 A7142 MAC - MAC: 32-384 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 HMAC-SHA3-512 A7142 MAC - MAC: 32-512 Increment 8 FIPS 198-1 Key Length - Key Length: 112-2048 Increment 8 KAS-ECC CDH- A7142 Curve - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-224, P-256, P-384, P-521 SP 800-56A Component SP800-56Ar3 Rev. 3 (CVL) KAS-ECC-SSC Sp800- A7142 Domain Parameter Generation Methods - B-233, B-283, B-409, B-571, K-233, K-283, K-409, K-571, P-224, P-256, SP 800-56A 56Ar3 P-384, P-521 Rev. 3 Scheme ephemeralUnified KAS Role - initiator, responder KAS-FFC-SSC Sp800- A7142 Domain Parameter Generation Methods - FB, FC, ffdhe2048, ffdhe3072, ffdhe4096, ffdhe6144, ffdhe8192, SP 800-56A 56Ar3 modp-2048, modp-3072, modp-4096, modp-6144, modp-8192 Rev. 3 Scheme dhEphem KAS Role - initiator, responder KAS-IFC-SSC A7142 Modulo - 2048, 3072, 4096, 6144, 8192 SP 800-56A Key Generation Methods - rsakpg1-basic, rsakpg1-crt, rsakpg1-prime-factor, rsakpg2-basic, rsakpg2-crt, rsakpg2- Rev. 3 prime-factor Scheme KAS1 -
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference KAS Role - initiator, responder KAS2 KAS Role - initiator, responder Fixed Public Exponent - 010001 KDA HKDF SP800-56Cr2 A7142 Fixed Info Pattern - algorithmId||l||uPartyInfo||vPartyInfo SP 800-56C Fixed Info Encoding - concatenation Rev. 2 Derived Key Length - 2048 Shared Secret Length - Shared Secret Length: 224-8192 Increment 8 HMAC Algorithm - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256, SHA3-224, SHA3-256, SHA3-384, SHA3-512 Perform Multiple Expansion Tests - No Uses Hybrid Shared Secret - No KDA OneStep SP800- A7142 Auxiliary Function Methods - SP 800-56C 56Cr2 Auxiliary Function Name - SHA2-512 Rev. 2 MAC Salting Methods - default, random Fixed Info Pattern - algorithmId||l||uPartyInfo||vPartyInfo Fixed Info Encoding - concatenation Derived Key Length - 2048 Shared Secret Length - Shared Secret Length: 224-8192 Increment 8 KDA TwoStep SP800- A7142 MAC Salting Methods - default, random SP 800-56C 56Cr2 Fixed Info Pattern - algorithmId||l||uPartyInfo||vPartyInfo Rev. 2 Fixed Info Encoding - concatenation KDF Mode - feedback MAC Modes - HMAC-SHA-1, HMAC-SHA2-224, HMAC-SHA2-256, HMAC-SHA2-384, HMAC-SHA2-512, HMACSHA2-512/224, HMAC-SHA2-512/256, HMAC-SHA3-224, HMAC-SHA3-256, HMAC-SHA3-384, HMAC-SHA3-512 Fixed Data Order - after fixed data Counter Lengths - 8 The KDF supports an empty IV - Yes The KDF requires an empty IV - Yes Supported Lengths - Supported Lengths: 2048 Derived Key Length - 2048 Shared Secret Length - Shared Secret Length: 224-8192 Increment 8 Perform Multiple Expansion Tests - No Uses Hybrid Shared Secret - No KDF ANS 9.42 (CVL) A7142 KDF Type - DER SP 800-135 Hash Algorithm - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256, SHA3-224, Rev. 1 SHA3-256, SHA3-384, SHA3-512 Other Info Length - Other Info Length: 0-4096 Increment 8 zz Length - zz Length: 8-4096 Increment 8
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference Key Data Length - Key Data Length: 8-4096 Increment 8 Supplemental Information Length - Supplemental Information Length: 0-120 Increment 8 OID - AES-128-KW, AES-192-KW, AES-256-KW KDF ANS 9.63 (CVL) A7142 Hash Algorithm - SHA2-224, SHA2-256, SHA2-384, SHA2-512 SP 800-135 Field Size - 224, 571 Rev. 1 Shared Info Length - Shared Info Length: 0, 1024 Key Data Length - Key Data Length: 128, 4096 KDF SP800-108 A7142 KDF Mode - Counter, Feedback SP 800-108 MAC Mode - CMAC-AES128, CMAC-AES192, CMAC-AES256, HMAC-SHA-1, HMAC-SHA2-224, HMAC-SHA2-256, Rev. 1 HMAC-SHA2-384, HMAC-SHA2-512 Supported Lengths - Supported Lengths: 8, 72, 128, 776, 3456, 4096 Fixed Data Order - Before Fixed Data Counter Length - 32 Supports Empty IV - No, Yes Custom Key In Length - 0 Requires Empty IV - Yes KDF SSH (CVL) A7142 Cipher - AES-128, AES-192, AES-256 SP 800-135 Hash Algorithm - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512 Rev. 1 KMAC-128 A7142 Message Length - Message Length: 0-65536 Increment 8 SP 800-185 MAC Length - MAC Length: 32-65536 Increment 8 Key Data Length - Key Data Length: 128-1024 Increment 8 Hex Customization - No Supports eXtendable-Output Functions - No, Yes KMAC-256 A7142 Message Length - Message Length: 0-65536 Increment 8 SP 800-185 MAC Length - MAC Length: 32-65536 Increment 8 Key Data Length - Key Data Length: 128-1024 Increment 8 Hex Customization - No Supports eXtendable-Output Functions - No, Yes KTS-IFC A7142 Function - keyPairGen, partialVal SP 800-56B IUT ID - CAFEFACE Rev. 2 Modulo - 2048, 3072, 4096, 6144 Key Generation Methods - rsakpg1-basic, rsakpg1-crt, rsakpg1-prime-factor, rsakpg2-basic, rsakpg2-crt, rsakpg2prime-factor Fixed Public Exponent - 010001 Scheme KTS-OAEP-basic KAS Role - initiator, responder Key Transport Method Hash Algorithms - SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256, SHA3-224, SHA3-
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference 256, SHA3-384, SHA3-512 Supports Null Associated Data - Yes Associated Data Encoding - concatenation Key Length - 1024 PBKDF A7142 Iteration Count - Iteration Count: 1-10000 Increment 1 SP 800-132 HMAC Algorithm - SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512, SHA2-512/224, SHA2-512/256 Password Length - Password Length: 8-128 Increment 8 Salt Length - Salt Length: 128-4096 Increment 8 Key Data Length - Key Data Length: 112-4096 Increment 8 RSA KeyGen (FIPS186-4) A7142 Key Generation Mode - B.3.3 FIPS 186-4 Modulo - 2048, 3072, 4096 Primality Tests - Table C.2 Info Generated By Server - Yes Public Exponent Mode - Random Private Key Format - Standard RSA SigGen (FIPS186-4) A7142 Signature Type - ANSI X9.31, PKCS 1.5, PKCSPSS FIPS 186-4 Modulo - 2048, 3072, 4096 Hash Pair Hash Algorithm - SHA2-256 RSA SigGen (FIPS186-5) A7142 Hash Pair - FIPS 186-5 Hash Algorithm - SHA2-224 Modulo - 2048, 3072, 4096 Signature Type - pkcs1v1.5, pss Mask Function - MGF1 RSA Signature Primitive A7142 Private Key Format - crt FIPS 186-4 (CVL) Public Exponent Mode - fixed Fixed Public Exponent - 010001 RSA SigVer (FIPS186-4) A7142 Signature Type - ANSI X9.31, PKCS 1.5, PKCSPSS FIPS 186-4 Modulo - 1024, 2048, 3072, 4096 Hash Pair Hash Algorithm - SHA-1 Public Exponent Mode - Random RSA SigVer (FIPS186-5) A7142 Hash Pair - FIPS 186-5 Hash Algorithm - SHA2-224 Modulo - 2048, 3072, 4096 Signature Type - pkcs1v1.5, pss Mask Function - MGF1 Public Exponent Mode - random
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm CAVP Cert Properties Reference Safe Primes Key A7142 Safe Prime Groups - ffdhe2048, ffdhe3072, ffdhe4096, ffdhe6144, ffdhe8192, modp-2048, modp-3072, modp- SP 800-56A Generation 4096, modp-6144, modp-8192 Rev. 3 Safe Primes Key A7142 Safe Prime Groups - ffdhe2048, ffdhe3072, ffdhe4096, ffdhe6144, ffdhe8192, modp-2048, modp-3072, modp- SP 800-56A Verification 4096, modp-6144, modp-8192 Rev. 3 SHA-1 A7142 Message Length - Message Length: 0-65528 Increment 8 FIPS 180-4 SHA2-224 A7142 Message Length - Message Length: 0-65528 Increment 8 FIPS 180-4 SHA2-256 A7142 Message Length - Message Length: 0-65528 Increment 8 FIPS 180-4 SHA2-384 A7142 Message Length - Message Length: 0-65528 Increment 8 FIPS 180-4 SHA2-512 A7142 Message Length - Message Length: 0-65528 Increment 8 FIPS 180-4 SHA2-512/224 A7142 Message Length - Message Length: 0-65528 Increment 8 FIPS 180-4 SHA2-512/256 A7142 Message Length - Message Length: 0-65528 Increment 8 FIPS 180-4 SHA3-224 A7142 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 SHA3-256 A7142 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 SHA3-384 A7142 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 SHA3-512 A7142 Message Length - Message Length: 0-65536 Increment 8 FIPS 202 SHAKE-128 A7142 Supports Bit-Oriented Messages - No FIPS 202 Supports Empty Message - Yes Supports Bit-Oriented Output - No Output Length - Output Length: 16-65536 Increment 8 SHAKE-256 A7142 Supports Bit-Oriented Messages - No FIPS 202 Supports Empty Message - Yes Supports Bit-Oriented Output - No Output Length - Output Length: 16-65536 Increment 8 TLS v1.2 KDF RFC7627 A7142 Hash Algorithm - SHA2-256, SHA2-384, SHA2-512 SP 800-135 (CVL) Key Block Length - Key Block Length: 1024 Rev. 1 TLS v1.3 KDF (CVL) A7142 HMAC Algorithm - SHA2-256, SHA2-384 SP 800-135 KDF Running Modes - DHE, PSK, PSK-DHE Rev. 1 Table 6: Approved Algorithms Vendor-Affirmed Algorithms: Name Properties Implementation Reference CKG Section 4 KeyPair FIPS Provider for OpenSSL 3 NIST, SP 800-133 Rev. 2 CKG Section 5 KeyPair FIPS Provider for OpenSSL 3 NIST, SP 800-133 Rev. 2 CKG Section 6.2 KeyPair FIPS Provider for OpenSSL 3 NIST, SP 800-133 Rev. 2 Hash DRBG with SHA3-256, SHA3-512 KeyPair FIPS Provider for OpenSSL 3 NIST, SP 800-90A Rev. 1 HMAC DRBG with SHA3-256, SHA3-512 KeyPair FIPS Provider for OpenSSL 3 NIST, SP 800-90A Rev. 1 Table 7: Vendor-Affirmed Algorithms
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Non-Approved, Allowed Algorithms: N/A for this module. Non-Approved, Allowed Algorithms with No Security Claimed: N/A for this Module. Non-Approved, Not Allowed Algorithms: N/A for this Module.
Name Type Description Properties Algorithms Cipher (Unauth) BC-UnAuth AES ciphers AES-CBC: (A7142) AES-CBC-CS1: (A7142) AES-CBC-CS2: (A7142) AES-CBC-CS3: (A7142) AES-CFB1: (A7142) AES-CFB128: (A7142) AES-CFB8: (A7142) AES-CTR: (A7142) AES-ECB: (A7142) AES-OFB: (A7142) AES-XTS Testing Revision 2.0: (A7142) Cipher (Auth) BC-Auth Authenticated ciphers AES-CCM: (A7142) AES-GCM: (A7142) AES-KW: (A7142) AES-KWP: (A7142) CKG Section 4 CKG Using the Output of a Random CKG Section 4: () Bit Generator CKG Section 5 CKG Generation of Key Pairs for CKG Section 5: () Asymmetric-Key Algorithms CKG Section 6.2 CKG Derivation of Symmetric Keys CKG Section 6.2: () Key agreement KAS-SSC Key agreement KAS:KAS-ECC-SSC provides KAS-ECC CDH-Component between 112 and 256 bits of SP800-56Ar3: (A7142) encryption strength; KAS-FFC- KAS-ECC-SSC Sp800-56Ar3: SSC provides between 112 and (A7142)
KAS-IFC-SSC provides between (A7142) KAS-IFC-SSC: (A7142)
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Type Description Properties Algorithms
strength Key derivation KAS-135KDF KAS-KDF HKDF SP800-56Cr2: KAS-56CKDF (A7142) KBKDF KAS-KDF OneStep SP800-56Cr2: PBKDF (A7142) KAS-KDF TwoStep SP800-56Cr2: (A7142) KDF ANS 9.42: (A7142) KDF ANS 9.63: (A7142) KDF SP800-108: (A7142) KDF SSH: (A7142) PBKDF: (A7142) TLS v1.2 KDF RFC7627: (A7142) TLS v1.3 KDF: (A7142) Key management ECC AsymKeyPair-KeyGen ECDSA KeyGen (FIPS186-4): AsymKeyPair-KeyVer (A7142) ECDSA KeyVer (FIPS186-4): (A7142) Key management Edwards AsymKeyPair-KeyGen EDDSA KeyGen: (A7142) AsymKeyPair-KeyVer EDDSA KeyVer: (A7142) Key management FFC AsymKeyPair-KeyGen DSA KeyGen (FIPS186-4): (A7142) DSA PQGGen (FIPS186-4): (A7142) DSA PQGVer (FIPS186-4): (A7142) Safe Primes Key Generation: (A7142) Safe Primes Key Verification: (A7142) Key management IFC AsymKeyPair-KeyGen RSA KeyGen (FIPS186-4): (A7142) Key transport KTS-Encap KTS:2048, 3072, 4096 or 6144- KTS-IFC: (A7142) bit keys provide between 112 and 176 bits of encryption strength
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Type Description Properties Algorithms KTS (Cipher w/ CMAC, GMAC, BC-Auth SP 800-38F Section 3.1 KTS:128, 192 or 256-bit keys AES-CBC: (A7142) HMAC, KMAC) BC-UnAuth Provisions provide between 128 and 256 AES-CBC-CS1: (A7142) MAC bits of encryption strength AES-CBC-CS2: (A7142) AES-CBC-CS3: (A7142) AES-CFB1: (A7142) AES-CFB128: (A7142) AES-CFB8: (A7142) AES-CTR: (A7142) AES-ECB: (A7142) AES-OFB: (A7142) AES-CCM: (A7142) AES-GCM: (A7142) AES-GMAC: (A7142) AES-CMAC: (A7142) HMAC-SHA-1: (A7142) HMAC-SHA2-224: (A7142) HMAC-SHA2-256: (A7142) HMAC-SHA2-384: (A7142) HMAC-SHA2-512: (A7142) HMAC-SHA2-512/224: (A7142) HMAC-SHA2-512/256: (A7142) HMAC-SHA3-224: (A7142) HMAC-SHA3-256: (A7142) HMAC-SHA3-384: (A7142) HMAC-SHA3-512: (A7142) KMAC-128: (A7142) KMAC-256: (A7142) KTS (AES KW, KWP) BC-Auth KTS:128, 192 or 256-bit keys AES-KW: (A7142) provide between 128 and 256 AES-KWP: (A7142) bits of encryption strength MAC AES (CMAC, GMAC) MAC AES-GMAC: (A7142) AES-CMAC: (A7142) MAC HMAC MAC HMAC-SHA-1: (A7142) HMAC-SHA2-224: (A7142) HMAC-SHA2-256: (A7142) HMAC-SHA2-384: (A7142) HMAC-SHA2-512: (A7142) HMAC-SHA2-512/224: (A7142) HMAC-SHA2-512/256: (A7142)
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Type Description Properties Algorithms HMAC-SHA3-224: (A7142) HMAC-SHA3-256: (A7142) HMAC-SHA3-384: (A7142) HMAC-SHA3-512: (A7142) MAC KMAC (XOF) XOF KMAC-128: (A7142) KMAC-256: (A7142) Message Digest SHA SHA-1: (A7142) SHA2-224: (A7142) SHA2-256: (A7142) SHA2-384: (A7142) SHA2-512: (A7142) SHA2-512/224: (A7142) SHA2-512/256: (A7142) SHA3-224: (A7142) SHA3-256: (A7142) SHA3-384: (A7142) SHA3-512: (A7142) Message Digest (XOF SHAKE) XOF SHAKE-128: (A7142) SHAKE-256: (A7142) Random DRBG Counter DRBG: (A7142) Hash DRBG: (A7142) HMAC DRBG: (A7142) Signature DSA DigSig-SigGen DSA SigGen (FIPS186-4): DigSig-SigVer (A7142) DSA SigVer (FIPS186-4): (A7142) Signature ECDSA DigSig-SigGen ECDSA SigGen (FIPS186-4): DigSig-SigVer (A7142) ECDSA SigVer (FIPS186-4): (A7142) Signature EDDSA DigSig-SigGen EDDSA SigGen: (A7142) DigSig-SigVer EDDSA SigVer: (A7142) Signature RSA DigSig-SigGen RSA SigGen (FIPS186-4): DigSig-SigVer (A7142) RSA SigGen (FIPS186-5): (A7142) RSA Signature Primitive: (A7142) RSA SigVer (FIPS186-4): (A7142) RSA SigVer (FIPS186-5): (A7142)
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Table 8: Security Function Implementations
AES-GCM: The Module supports internal IV generation using the Approved DRBG. The IV is at least 96 bits in length per SP 800-38D Section 8.2.2, and the Approved DRBG generates outputs such that the (key, IV) pair collision probability is less than 2-32 per SP 800-38D Section 8. AES-GCM IVs shall be used in compliance with FIPS 140-3 IG C.H scenario 1a (TLS/DTLS 1.2, per RFC 5288), 1d (SSHv2, per RFC 5647) and 5 (TLS 1.3, per RFC 8446). The Module is compatible with TLS/DTLS 1.2 protocol and provides the primitives to support the AES GCM ciphersuites from SP 800-52 Rev. 1 Section 3.3.1. The Module’s implementation of AES-GCM is used together with one or more applications outside the Module’s cryptographic boundary that implement the specified protocols; these protocols have not been reviewed or tested by the CAVP and CMVP. In each of the protocols, if the Module’s power is lost and then restored, the key used for the AES GCM encryption/decryption shall be re-distributed. This condition is not enforced by the Module but is met implicitly. The Module does not retain any state across reset or power-cycles: AES-GCM key/IVs are not stored in non-volatile persistent memory (i.e., disk), hence no re-connection can occur without a fresh key establishment operation and the associated SSPs. The Module explicitly ensures that the counter (the nonce_explicit part of the IV) does not exhaust the maximum number of possible values of 264-1 for a given session key. If this exhaustion condition is observed, the Module returns an error indication to the calling application, which will then need to either abort the connection, or trigger a handshake to establish a new encryption key. XTS-AES: In accordance with SP 800-38E, the XTS-AES algorithm is to be used for confidentiality on storage devices. The Module complies with FIPS 140-3 IG C.I by:
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 The strength of the Data Protection Key is based on the strength of the Password and/or Passphrase used in key derivation. SP 800-132 does not impose any strictly defined requirements on the strength of a password. It says that “passwords should be strong enough so that it is infeasible for attackers to get access by guessing a password.” The choice to use the PBKDF with a password or passphrase is entirely outside the scope of the Module, managed by the calling application
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 SHA-3 and SHAKE: The Module complies with FIPS 140-3 IG C.C as follows:
N/A for this Module. The calling application is responsible for use of a SP 800-90B compliant entropy source outside the Module boundary providing at least 256 bits of security strength. Entropy is supplied to the Module via callback functions. The following caveat applies per FIPS 140-3 IG 9.3.A: No assurance of the minimum strength of generated SSPs (e.g., keys).
The Module:
The Module implements key agreement methods compliant with FIPS 140-3 IG D.F and key transport methods compliant with FIPS 140-3 IG D.G. Strengths are provided in Section 2.6.
The Module conforms to FIPS 140-3 IG D.C References to the Support of Industry Protocols: while it provides SP 800-56A Rev. 3 conformant schemes and API entry points oriented to TLS usage, the Module does not contain the full implementation of TLS. The following caveat is required: No parts of the TLS protocol, other than the approved cryptographic algorithms and the KDFs, have been tested by the CAVP and CMVP.
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
Physical Port Logical Data That Passes Interface(s) N/A (API - input) Control Input API input: stack frame including non-sensitive parameters. Data Input N/A (API - output) Data Output API output: output parameters and return value resulting from call execution. Status Output Table 9: Ports and Interfaces The Module does not interact with physical ports. The Control Output interface is not applicable, as the Module does not control other components.
Name Type Operator Type Authentication Methods CO Role CO Table 10: Roles The Module supports the mandatory Cryptographic Officer (CO) operational role only (implicitly identified), and does not support a maintenance role or a bypass capability. The Module does not provide an authentication or identification method of its own. The CO role is assumed by meeting the conditions of Section 11 of this document and in associated Guidance Documentation.
Name Description Indicator Inputs Outputs Security SSP Access Functions Cipher Encrypt or decrypt data, FIPS_OK Encryption or decryption key; Status return. Plaintext Cipher (Unauth) CO including AEAD modes (CCM, plaintext or ciphertext data; flags. or ciphertext data. Cipher (Auth) - SC_EDK_AES: W,E GCM). - SC_EDK_XTS: W,E Get capabilities Reports information on the FIPS_OK Provider context, capability, Description of requested capabilities. callback pointer and arguments. capabilities. Initialize Module initialization, FIPS_OK Core handle, dispatch in and out, Initialization status (1 = Random CO including instantiation of the provider context. pass, 0 = fail). MAC HMAC - DRBG_EI: W,E,Z
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Indicator Inputs Outputs Security SSP Access Functions opaque (managed within the - DRBG_Seed: G,E,Z module) Counter DRBG - DRBG_Key: G,W,E instance. - DRBG_V: G,W,E Key agreement Perform key agreement FIPS_OK Key structs (key agreement keys); Status return; key CKG Section 5 CO primitives on behalf of the flags. agreement shared Key agreement - KAS_Private_ECC: calling process (does not secret. W,E establish keys into the - KAS_Public_ECC: W,E module). - KAS_Private_FFC: W,E - KAS_Public_FFC: W,E - KAS_Private_IFC: W,E - KAS_Public_IFC: W,E - KAS_SS_ECC: G,R - KAS_SS_FFC: G,R - KAS_SS_IFC: G,R Key derivation Derive keying material from a FIPS_OK Key agreement shared secret; Status return; derived Key derivation CO shared secret. flags. keying material. CKG Section 6.2 - KD_DKM_KDF: G,R - KD_PW_PBKDF: W,E - KD_DKM_PBKDF: G,R - KD_SK: W,E Key management Generate asymmetric key FIPS_OK ECDSA, EdDSA: curve identifier. Status return; general Key management CO pairs. DSA, RSA: domain parameter digital signature ECC - DRBG_C: G,W,E targets. private and public Key management - DRBG_Key: W,G,E keys. Edwards - DRBG_V: W,G,E Key management - GKP_Private_ECC: G,R FFC - GKP_Public_ECC: G,R Key management IFC GKP_Private_Edwards: CKG Section 4 G,R - GKP_Public_Edwards: G,R - GKP_Private_FFC: G,R - GKP_Public_FFC: G,R - GKP_Private_IFC: G,R - GKP_Public_IFC: G,R Key transport Encapsulate or decapsulate FIPS_OK Key encapsulation/decapsulation Status return; key CKG Section 5 CO key material on behalf of the key or Key wrap/unwrap key. transport shared Key transport - KTS_KDK_IFC: W,E calling process. secret. KTS (Cipher w/ - KTS_KEK_IFC: W,E CMAC, GMAC, - KTS_SS_IFC: G,R
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Indicator Inputs Outputs Security SSP Access Functions HMAC, KMAC) KTS (AES KW, KWP) Message Generate or verify data FIPS_OK Keyed hash key. Status return; MAC MAC AES (CMAC, CO authentication integrity. output value. GMAC) - KH_Key_AES-CMAC: MAC HMAC W,E MAC KMAC (XOF) - KH_Key_AES-GMAC: W,E - KH_Key_HMAC: W,E - KH_Key_KMAC: W,E Message digest Generate a message digest. FIPS_OK Message; flags. Status return; Hash Message Digest output value. Message Digest (XOF SHAKE) Query Report available crypto FIPS_OK Provider context, operation ID. Array of available operations. operations. Random Generate random bits using FIPS_OK DRBG struct (RBG State); Status return; Random Random CO the DRBG. DRBG_Seed. value. CKG Section 4 - DRBG_C: W,E - DRBG_EI: W,E,Z - DRBG_Seed: G,E,Z - DRBG_Key: W,E - DRBG_V: W,E Self-test Perform the self-test FIPS_OK Provider context. Status (1 = pass, 0 = sequence. fail). Show module Return module name and FIPS_OK Provider context, parameter types Parameter types name and versioning information. (array). (array) with: Name, versioning Version. information Show status OpenSSL core metadata FIPS_OK Provider context, parameter types Parameter types with: (Gettable parameters; Get (array). BuildInfo, Status, parameters). SecurityChecks; Status return. Signature Generate or verify digital FIPS_OK Sign: signing key; message. Verify: Status return; CKG Section 5 CO signatures. (SSPs are passed in signature value; flags; sizes. Signature value. Signature DSA - DS_SGK_ECC: W,E by the calling process.) Signature ECDSA - DS_SVK_ECC: W,E Signature EDDSA - DS_SGK_Edwards: Signature RSA W,E - DS_SVK_Edwards: W,E
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Indicator Inputs Outputs Security SSP Access Functions - DS_SGK_FFC: W,E - DS_SVK_FFC: W,E - DS_SGK_IFC: W,E - DS_SVK_IFC: W,E Teardown Uninstantiate the module; FIPS_OK Provider context. None. CO zeroizes internal CTR DRBG - DRBG_Key: Z state (DRBG_Key, DRBG_V). - DRBG_V: Z Zeroize Zeroization of allocated key FIPS_OK Memory pointer. Void. CO structures using - DRBG_C: Z openssl_cleanse. - DRBG_EI: Z - DRBG_Key: Z - DRBG_Seed: Z - DRBG_V: Z - DS_SGK_ECC: Z - DS_SGK_Edwards: Z - DS_SGK_FFC: Z - DS_SGK_IFC: Z - DS_SVK_ECC: Z - DS_SVK_Edwards: Z - DS_SVK_FFC: Z - DS_SVK_IFC: Z - GKP_Private_ECC: Z GKP_Private_Edwards: Z - GKP_Private_FFC: Z - GKP_Private_IFC: Z - GKP_Public_ECC: Z - GKP_Public_Edwards: Z - GKP_Public_FFC: Z - GKP_Public_IFC: Z - KAS_Private_ECC: Z - KAS_Private_FFC: Z - GKP_Private_ECC: Z - KAS_Private_IFC: Z - KAS_Public_ECC: Z - KAS_Public_FFC: Z
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Indicator Inputs Outputs Security SSP Access Functions - KAS_Public_IFC: Z - KAS_SS_ECC: Z - KD_DKM_KDF: Z - KD_DKM_PBKDF: Z - KD_SK: Z - KH_Key_AES-CMAC: Z - KH_Key_AES-GMAC: Z - KH_Key_HMAC: Z - KH_Key_KMAC: Z - KTS_KDK_IFC: Z - KTS_KEK_IFC: Z - KTS_SS_IFC: Z - KAS_SS_ECC: Z - SC_EDK_AES: Z - SC_EDK_XTS: Z Table 11: Approved Services All services implemented by the Module correspond to the functionality described by the fips_query function, which returns available services based on an operation_id input. The fips_get_params function provides access to the current status of the Module as well as the name and version; this information correlates to the validation listing. A 1 value returned in status indicates the Module is running without error (FIPS_OK); a 0 return indicates an error (with additional error details indicated as described in the release specific API documentation). Services are only operational in the running state. Any attempts to access services in any other state will result in an error being returned. If the integrity test or any CAST fails then any attempt to access any service will result in an error being returned. The OpenSSL toolkit OSSL_PROVIDER_get_params function is used to invoke fips_get_params, when called with the Module’s global handle and a pointer to a parameter structure (initialized using provider_gettable_params or the equivalent). Regarding the Indicator of approved security services, the Module conforms to FIPS 140-3 IG 2.4.C Approved Security Service Indicator, similar to example 2. Each service provides context sensitive status responses as described in the OpenSSL 3 API manual pages; generally, functions of return type int return the value 1 for success with other error codes as appropriate for the call (described in API documentation). The Module’s name and version parameters (as cited in Section 2) along with the Module’s internal indicators of the security-check and conditional-errors settings are used to confirm the Module is the validated Module operating in the approved mode with only approved security services. Note that the caller provides the KAS_Private and KAS_Public keys for shared secret computation; the caller’s exchange and assurance of PSPs with the remote participant is outside the scope of the Module.
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
The Module uses HMAC-SHA2-256 as the approved integrity technique; the file fips.so.mac contains the integrity reference value. The Module is provided in an executable form (as fips.so shared object for use in Linux environments).
The operator can initiate the integrity test on demand by calling fips_self_test (invoked using OSSL_PROVIDER_self_test called with the Module’s global handle) or reloading the Module.
In accordance with ISO/IEC 19790:2012 Annex B, as the Module is open source, the tools used to build the Module as tested are:
Type of Operational Environment: Modifiable No operational environment restrictions are required for operation in the approved mode. All conditions for operation of the Module in the approved mode are given in Section 2.4. The Module conforms to FIPS 140-3 IG 2.3.C Processor Algorithm Accelerators (PAA) and Processor Algorithm Implementation (PAI). The AES-NI functions are identified by FIPS 140-3 IG 2.3.C as a known PAA.
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
Storage Description Persistence Area Type Name RAM R: Random access memory Dynamic Table 12: Storage Areas
Name From To Format Distribution Entry SFI or Type Type Type Algorithm I Calling process Call stack (API) input parameters Plaintext Manual Electronic O Call stack (API) output parameters Calling process Plaintext Manual Electronic Table 13: SSP Input-Output Methods
Zeroization Description Rationale Operator Initiation Method C C (Cleanse): Caller invocation of openssl_cleanse. Overwrites with zeros Caller invocation of openssl_cleanse T T (Teardown): Module unload - invokes cleanse internally. Overwrites with zeros Occurs when module is unloaded Table 14: SSP Zeroization Methods All SSPs are zeroized (overwritten with 0s) when they are no longer needed:
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
Name Description Size - Strength Type - Category Generated By Established Used By By DRBG_C Element of Hash DRBG Size: 440-888 - Hash_DRBG_C - CSP Random Random state. Strength: 160 = s = 256 DRBG_EI Entropy input from an Size: 128-2^35 - Other - CSP Random external source used Strength: 128 = s = 256 for DRBG seeding. DRBG_Key Element of CTR DRBG Size: 128-256, 128-256 - CTR_DRBG_Key, HMAC_DRBG_Key Random Random or HMAC DRBG state. Strength: 128 = s = 256, 160 = s = - CSP DRBG_Seed Seed used for DRBG Size: 128-256 - Other - CSP Random Random Instantiation and Strength: 128 = s = 256 Reseed. DRBG_V Element of CTR, Hash Size: 128-256, 128-256, 128-256 CTR_DRBG_Key, Hash_DRBG_Key, Random Random or HMAC DRBG state. - HMAC_DRBG_Key - CSP Strength: 128 = s = 256, 128 = s = 256, 128 = s = 256 DS_SGK_ECC SigGen (private) key. Size: 233, 283, 409, 571, 233, B-233, B-283, B-409, B-571, K-233, Signature 283, 409, 571, 224, 256, 384, K-283, K-409, K-571, P-224, P-256, ECDSA
Strength: s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256 DS_SGK_Edwards SigGen (private) key. Size: 255, 448 - Edwards25519, Edwards448 - CSP Signature Strength: s = 128, s = 224 EDDSA DS_SGK_FFC SigGen (private) key. Size: 2048, 2048, 3072 - L=2048/N=224, L=2048/N=256, Signature DSA Strength: s = 112, s = 112, s = L=3072/N=256 - CSP DS_SGK_IFC SigGen (private) key. Size: 2048, 3072, 4096, 6144, k=2048, k=3072, k=4096, k=6144, Signature RSA
Strength: s = 112, s = 128, s = 152, s = 176, s = 200 DS_SVK_ECC SigVer (public) key. Size: 163, 233, 283, 409, 571, B-163, B-233, B-283, B-409, B-571, Signature 163, 233, 283, 409, 571, 192, K-163, K-233, K-283, K-409, K-571, ECDSA 224, 256, 384, 521 - P-192, P-224, P-256, P-384, P-521 Strength: s < 112, s = 112, s = PSP 128, s = 192, s = 256, s < 112, s =
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Size - Strength Type - Category Generated By Established Used By By 112, s = 128, s = 192, s = 256, s < 112, s = 112, s = 128, s = 192, s = DS_SVK_Edwards SigVer (public) key. Size: 255, 448 - Edwards25519, Edwards448 - PSP Signature Strength: s = 128, s = 224 EDDSA DS_SVK_FFC SigVer (public) key. Size: 1024, 2048, 2048, 3072 - L=1024/N=160, L=2048/N=224, Signature DSA Strength: s < 112, s = 112, s = L=2048/N=256, L=3072/N=256 112, s = 128 PSP DS_SVK_IFC SigVer (public) key. Size: 1024, 2048, 3072, 4096, k=1024, k=2048, k=3072, k=4096, Signature RSA 6144, 8192 - k=6144, k=8192 - PSP Strength: s = 112, s = 112, s = 128, s = 152, s = 176, s = 200 GKP_Private_ECC General ECDSA Size: 233, 283, 409, 571, 233, B-233, B-283, B-409, B-571, K-233, Key Key (private) key. 283, 409, 571, 224, 256, 384, K-283, K-409, K-571, P-224, P-256, management management
521 - P-384, P-521 - CSP ECC ECC
Strength: s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256 GKP_Private_Edwards General EdDSA Size: 255, 448 - Edwards25519, Edwards448 - CSP Key Key (private) key. Strength: s = 128, s = 224 management management Edwards Edwards GKP_Private_FFC General FFC (private) Size: 2048, 2048, 3072 - L=2048/N=224, L=2048/N=256, Key Key key. Strength: s = 112, s = 112, s = L=3072/N=256 - CSP management management
128 FFC FFC
GKP_Private_IFC General RSA (private) Size: 2048, 3072, 4096, 6144, k=2048, k=3072, k=4096, k=6144, Key Key key. 8192 - k=8192 - CSP management management Strength: s = 112, s = 128, s = IFC IFC 152, s = 176, s = 200 GKP_Public_ECC General ECDSA (public) Size: 233, 283, 409, 571, 233, B-233, B-283, B-409, B-571, K-233, Key Key key. 283, 409, 571, 224, 256, 384, K-283, K-409, K-571, P-224, P-256, management management
521 - P-384, P-521 - PSP ECC ECC
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Size - Strength Type - Category Generated By Established Used By By GKP_Public_Edwards General EdDSA (public) Size: 255, 448 - Edwards25519, Edwards448 - PSP Key Key key. Strength: s = 128, s = 224 management management Edwards Edwards GKP_Public_FFC General FFC (public) Size: 2048, 2048, 3072 - L=2048/N=224, L=2048/N=256, Key Key key. Strength: s = 112, s = 112, s = L=3072/N=256 - PSP management management
128 FFC FFC
GKP_Public_IFC General RSA (public) Size: 2048, 3072, 4096, 6144, k=2048, k=3072, k=4096, k=6144, Key Key key. 8192 - k=8192 - PSP management management Strength: s = 112, s = 128, s = IFC IFC 152, s = 176, s = 200 KAS_Private_ECC Key pair component Size: 233, 283, 409, 571, 233, B-233, B-283, B-409, B-571, K-233, Key agreement used for shared secret 283, 409, 571, 224, 256, 384, K-283, K-409, K-571, P-224, P-256, generation. 521 - P-384, P-521 - CSP Strength: s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256 KAS_Private_FFC Key pair component Size: 2048, 3072, 4096, 6144, ffdhe2048, ffdhe3072, ffdhe4096, Key agreement used for shared secret 8192 - ffdhe6144, ffdhe8192 - CSP generation. Strength: s = 112, 112 = s = 128,
= s = 200 KAS_Private_IFC Key pair component Size: 2048, 3072, 4096, 6144, k=2048, k=3072, k=4096, k=6144, Key agreement used for shared secret 8192 - k=8192 - CSP generation. Strength: s = 112, s = 128, s = 152, s = 176, s = 200 KAS_Public_ECC Peer key pair Size: 233, 283, 409, 571, 233, B-233, B-283, B-409, B-571, K-233, Key agreement component used for 283, 409, 571, 224, 256, 384, K-283, K-409, K-571, P-224, P-256, shared secret 521 - P-384, P-521 - PSP generation. Strength: s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256, s = 112, s = 128, s = 192, s = 256 KAS_Public_FFC Peer key pair Size: 2048, 3072, 4096, 6144, ffdhe2048, ffdhe3072, ffdhe4096, Key agreement component used for 8192 - ffdhe6144, ffdhe8192 - PSP shared secret Strength: s = 112, 112 = s = 128, generation. 112 = s = 152, 112 = s = 176, 112 = s = 200
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Size - Strength Type - Category Generated By Established Used By By KAS_Public_IFC Peer key pair Size: 2048, 3072, 4096, 6144, k=2048, k=3072, k=4096, k=6144, Key agreement component used for 8192 - k=8192 - PSP shared secret Strength: s = 112, s = 128, s = generation. 152, s = 176, s = 200 KAS_SS_ECC Shared secret Size: 112 - 256 - Other - CSP Key Key agreement calculation z output Strength: 112 - 256 agreement value (for KDF). KAS_SS_FFC Shared secret Size: 112 - 256 - Other - CSP Key Key agreement calculation z output Strength: 112 - 200 agreement value (for KDF). KAS_SS_IFC Shared secret Size: 112 - 256 - Other - CSP Key Key agreement calculation z output Strength: 112 - 200 agreement value (for KDF). KD_DKM_KDF Key derivation derived Size: 128 - 256 - Other - CSP Key derivation Key derivation keying material. Strength: 128 - 256 KD_DKM_PBKDF PBKDF derived key Size: 128 - Other - CSP Key derivation Key derivation material Strength: 128 KD_PW_PBKDF PBKDF password input. Size: 128 - Other - CSP Key derivation Key derivation Strength: 128 KD_SK Key derivation source Size: 128 - 256 - Other - CSP Key derivation key material. Strength: 128 - 256 KH_Key_AES-CMAC Keyed Hash key. Size: 128, 192, 256 - AES-128, AES-192, AES-256 - CSP MAC AES Strength: s = 128, s = 192, s = (CMAC, GMAC) KH_Key_AES-GMAC Keyed Hash key. Size: 128, 192, 256 - AES-128, AES-192, AES-256 - CSP MAC AES Strength: s = 128, s = 192, s = (CMAC, GMAC) KH_Key_HMAC Keyed Hash key. Size: 112 - 2048 - Other - CSP MAC HMAC Strength: 112 - 256 KH_Key_KMAC Keyed Hash key. Size: 128, 256 - KMAC128, KMAC256 - CSP MAC KMAC Strength: 112 = s = 128, 112 = s = (XOF) KTS_KDK_IFC RSA key de- Size: 2048, 3072, 4096, 6144 - Other - CSP Key transport encapsulation Key (key Strength: s = 112, s = 128, s = transport). 152, s = 176
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Description Size - Strength Type - Category Generated By Established Used By By KTS_KEK_IFC RSA key encapsulation Size: 2048, 3072, 4096, 6144 - Other - PSP Key transport Key (key transport). Strength: s = 112, s = 128, s = 152, s = 176 KTS_SS_IFC RSA key transport Size: 112 - 256 - Other - CSP Key Key transport shared secret. Strength: s = 112 - s = 176 transport SC_EDK_AES Symmetric encryption Size: 128, 192, 256 - AES-128, AES-192, AES-256 - CSP Cipher and decryption. Strength: s = 128, s = 192, s = (Unauth)
256 Cipher (Auth)
SC_EDK_XTS Symmetric encryption Size: 256, 512 - XTS-128, XTS-256 - CSP Cipher and decryption. Strength: s = 128, s = 256 (Unauth) Table 15: SSP Table 1 Name Input - Storage Storage Duration Zeroization Related SSPs Output DRBG_C I RAM:Plaintext Call lifetime C DRBG_Seed:Derived From O DRBG_V:Used with DRBG_EI I RAM:Plaintext Call lifetime C DRBG_Seed:Constituent DRBG_Key I RAM:Plaintext Call lifetime (module up time for internal DRBG) C DRBG_Seed:Derived From O T DRBG_V:Used with DRBG_Seed RAM:Plaintext Call lifetime C DRBG_C:Derives DRBG_Key:Derives DRBG_V:Derives DRBG_EI:Incorporates DRBG_V I RAM:Plaintext Call lifetime (module up time for internal DRBG) C DRBG_Seed:Derived From O T DRBG_Key:Used with DS_SGK_ECC I RAM:Plaintext Call lifetime C DS_SVK_ECC:Paired With DS_SGK_Edwards I RAM:Plaintext Call lifetime C DS_SVK_Edwards:Paired With DS_SGK_FFC I RAM:Plaintext Call lifetime C DS_SVK_FFC:Paired With DS_SGK_IFC I RAM:Plaintext Call lifetime C DS_SVK_IFC:Paired With DS_SVK_ECC I RAM:Plaintext Call lifetime C DS_SGK_ECC:Paired With DS_SVK_Edwards I RAM:Plaintext Call lifetime C DS_SGK_Edwards:Paired With DS_SVK_FFC I RAM:Plaintext Call lifetime C DS_SGK_FFC:Paired With DS_SVK_IFC I RAM:Plaintext Call lifetime C DS_SGK_IFC:Paired With GKP_Private_ECC O RAM:Plaintext Call lifetime C GKP_Public_ECC:Paired With GKP_Private_Edwards O RAM:Plaintext Call lifetime C GKP_Public_Edwards:Paired With GKP_Private_FFC O RAM:Plaintext Call lifetime C GKP_Public_FFC:Paired With
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Name Input - Storage Storage Duration Zeroization Related SSPs Output GKP_Private_IFC O RAM:Plaintext Call lifetime C GKP_Public_IFC:Paired With GKP_Public_ECC O RAM:Plaintext Call lifetime C GKP_Private_ECC:Paired With GKP_Public_Edwards O RAM:Plaintext Call lifetime C GKP_Private_Edwards:Paired With GKP_Public_FFC O RAM:Plaintext Call lifetime C GKP_Private_FFC:Paired With GKP_Public_IFC O RAM:Plaintext Call lifetime C GKP_Private_IFC:Paired With KAS_Private_ECC I RAM:Plaintext Call lifetime C KAS_Public_ECC:Paired With KAS_Private_FFC I RAM:Plaintext Call lifetime C KAS_Public_FFC:Paired With KAS_Private_IFC I RAM:Plaintext Call lifetime C KAS_Public_IFC:Paired With KAS_Public_ECC I RAM:Plaintext Call lifetime C KAS_Private_ECC:Paired With KAS_Public_FFC I RAM:Plaintext Call lifetime C KAS_Private_FFC:Paired With KAS_Public_IFC I RAM:Plaintext Call lifetime C KAS_Private_IFC:Paired With KAS_SS_ECC O RAM:Plaintext Call lifetime C KAS_Private_ECC:Calculated From KAS_Public_ECC:Calculated From KAS_SS_FFC O RAM:Plaintext Call lifetime C KAS_Private_FFC:Calculated From KAS_Public_FFC:Calculated From KAS_SS_IFC O RAM:Plaintext Call lifetime C KAS_Private_IFC:Calculated From KAS_Public_IFC:Calculated From KD_DKM_KDF O RAM:Plaintext Call lifetime C KD_SK:Derived From KD_DKM_PBKDF O RAM:Plaintext Call lifetime C KD_PW_PBKDF:Derived From KD_PW_PBKDF I RAM:Plaintext Call lifetime C KD_DKM_PBKDF:Derives KD_SK I RAM:Plaintext Call lifetime C KD_DKM_KDF:Derives KH_Key_AES-CMAC I RAM:Plaintext Call lifetime C KH_Key_AES-GMAC I RAM:Plaintext Call lifetime C KH_Key_HMAC I RAM:Plaintext Call lifetime C KH_Key_KMAC I RAM:Plaintext Call lifetime C KTS_KDK_IFC I RAM:Plaintext Call lifetime C KTS_SS_IFC:Unwraps KTS_KEK_IFC I RAM:Plaintext Call lifetime C KTS_SS_IFC:Wraps KTS_SS_IFC O RAM:Plaintext Call lifetime C KTS_KDK_IFC:Unwrapped By KTS_KEK_IFC:Wrapped By SC_EDK_AES I RAM:Plaintext Call lifetime C SC_EDK_XTS I RAM:Plaintext Call lifetime C Table 16: SSP Table 2 Keys used for CASTs and the temporary value used in the integrity test are not SSPs; however, the latter is deleted after use as required by AS05.10.
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 The Module maintains only the Counter DRBG state used for key generation as a persistent CSP; this DRBG instance is used exclusively for approved services.
Key/Algorithm Type Equivalent Strengths: Reference sources for the strengths provided in SSP Table 1 are specified below. Equivalent strength is given for each key or algorithm type (as some algorithms do not use or produce keys). Block Cipher (and related functions): • AES (AES-128, AES-192, AES-256): SP 800-57 Part 1 Rev. 5 Table
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
Algorithm Test Properties Test Method Test Type Indicator Details or Test SW Integrity HMAC-SHA2-256 #A7142 HMAC over the complete module file image SW/FW Integrity FIPS_OK or PROV_R_FIPS_MODULE_IN_ERROR_STATE Table 17: Pre-Operational Self-Tests
Algorithm or Test Properties Test Test Indicator Details Conditions Test Method Type AES-ECB 128-bit KAT CAST FIPS_OK Encrypt Performed on module load. AES-ECB 128-bit KAT CAST FIPS_OK Decrypt Performed on module load. AES-GCM 256-bit KAT CAST FIPS_OK Encrypt Performed on module load. AES-GCM 256-bit KAT CAST FIPS_OK Decrypt Performed on module load. Counter DRBG AES-128 with derivation KAT CAST FIPS_OK Instantiate, Generate, Reseed Performed on module load. function DSA SigGen 2048-bit with SHA2-384 KAT CAST FIPS_OK Sign Performed on module load. (FIPS186-4) DSA SigVer 2048-bit with SHA2-384 KAT CAST FIPS_OK Verify Performed on module load. (FIPS186-4) ECDSA SigGen P-224 with SHA2-512 KAT CAST FIPS_OK Sign Performed on module load. (FIPS186-4) ECDSA SigVer P-224 with SHA2-512 KAT CAST FIPS_OK Verify Performed on module load. (FIPS186-4) EDDSA ED448 Edwards448 SigGen with SHA2- KAT CAST FIPS_OK Sign Performed on module load. SigGen 256 EDDSA ED448 Edwards448 SigVer with SHA2- KAT CAST FIPS_OK Verify Performed on module load. SigVer 256 EDDSA ED25519 Edwards25519 SigGen with KAT CAST FIPS_OK Sign Performed on module load. SigGen SHA2-512 EDDSA ED25519 Edwards25519 SigVer with KAT CAST FIPS_OK Verify Performed on module load. SigVer SHA2-512 Hash DRBG SHA2-256 KAT CAST FIPS_OK Instantiate, Generate, Reseed Performed on module load. HMAC DRBG SHA-1 KAT CAST FIPS_OK Instantiate, Generate, Reseed Performed on module load. HMAC-SHA2-256 SHA2-256 with a 256-bit key KAT CAST FIPS_OK Generate Performed on module load.
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm or Test Properties Test Test Indicator Details Conditions Test Method Type KAS-ECC-SSC P-256 KAT CAST FIPS_OK Ephemeral Unified Shared Secret Performed on module load. Sp800-56Ar3 (Z) Computation KAS-FFC-SSC L=2048/N=256 KAT CAST FIPS_OK dhEphem Shared Secret (Z) Performed on module load. Sp800-56Ar3 Computation KAS-IFC-SSC k=2048 KAT CAST FIPS_OK SP 800-56B Rev. 2 Section 8.2.2 RSA Performed on module load. Primitive Computation KAS-KDF SHA2-224 KAT CAST FIPS_OK SP 800-56C Rev. 2 Section 4 Performed on module load. OneStep SP800- OneStep KDF (AKA OpenSSL single56Cr2 step or SS-KDF) KAS-KDF SHA2-256 KAT CAST FIPS_OK SP 800-56C Rev. 2 Section 5 Performed on module load. TwoStep SP800- TwoStep KDF (HKDF variant) 56Cr2 KDF ANS 9.42 Fixed input KAT KAT CAST FIPS_OK SP 800-135 Rev. 1 Section 5.1 ANSI Performed on module load. X9.42-2001 KDF KAT KDF ANS 9.63 Fixed input KAT KAT CAST FIPS_OK SP 800-135 Rev. 1 Section 5.1 Performed on module load. X9.63-2001 KDF KAT KDF SP800-108 HMAC-SHA2-256 KAT CAST FIPS_OK SP 800-108 Rev. 1 Section 4.1 KAT Performed on module load. for a Counter Mode KDF KDF SSH Fixed input KAT KAT CAST FIPS_OK SP 800-135 Rev. 1 Section 5.2 Performed on module load. SSHv2 KDF KAT KTS-IFC k=2048 KAT CAST FIPS_OK SP 800-56B Rev. 2 Decrypt for CRT Performed on module load. KTS-IFC k=2048 KAT CAST FIPS_OK SP 800-56B Rev. 2 Encrypt for Basic Performed on module load. KTS-IFC k=2048 KAT CAST FIPS_OK SP 800-56B Rev. 2 Decrypt for Basic Performed on module load. PBKDF SHA2-256, 24-byte password, KAT CAST FIPS_OK SP 800-132 Section 5.3 KAT of Performed on module load. 36-byte salt, iteration count of Master Key derivation 4096 RSA SigGen k=2048 with SHA2-256 KAT CAST FIPS_OK Sign Performed on module load. (FIPS186-4) RSA SigVer k=2048 with SHA2-256 KAT CAST FIPS_OK Verify Performed on module load. (FIPS186-4) SHA-1 SHA-1 KAT CAST FIPS_OK Simple SHA KAT Performed on module load. SHA2-512 SHA2-512 KAT CAST FIPS_OK Simple SHA KAT Performed on module load. SHA3-256 SHA3-256 KAT CAST FIPS_OK Simple SHA KAT Performed on module load. TLS v1.2 KDF Fixed input KAT KAT CAST FIPS_OK SP 800-135 Rev. 1 Section 4.2.2 TLS Performed on module load. RFC7627 1.2 KAT
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm or Test Properties Test Test Indicator Details Conditions Test Method Type TLS v1.3 KDF Fixed input KAT KAT CAST FIPS_OK RFC8446 Section 7.1 TLS v1.3 KDF Performed on module load. KAT DSA KeyGen PCT performed using the PCT PCT FIPS_OK Sign, Verify Performed on FFC (DSA, KAS-FFC-SSC) key pair (FIPS186-4) generated key pair generation, prior to returning the key pair on conclusion of the call. ECDSA KeyGen PCT performed using the PCT PCT FIPS_OK Sign, Verify Performed on ECC (ECDSA) key pair generation, (FIPS186-4) generated key pair prior to returning the key pair on conclusion of the call. EDDSA KeyGen PCT performed using the PCT PCT FIPS_OK Sign, Verify Performed on Edwards (EdDSA) key pair generated key pair generation, prior to returning the key pair on conclusion of the call. RSA KeyGen PCT performed using the PCT PCT FIPS_OK Sign, Verify Performed on IFC (RSA, KAS-IFC-SSC, KTS-IFC) key (FIPS186-4) generated key pair pair generation, prior to returning the key pair on conclusion of the call. Table 18: Conditional Self-Tests The intended usage of asymmetric key pairs generated by the Module is not known at the time when the key pair is generated and the pairwise consistency test (PCT) is performed. In all cases, a sign and verify PCT is performed.
Algorithm or Test Test Method Test Type Period Periodic Method SW Integrity HMAC over the complete SW/FW Integrity On demand Module load module file image Table 19: Pre-Operational Periodic Information Algorithm or Test Test Method Test Type Period Periodic Method AES-ECB KAT CAST On demand On power on or reset AES-ECB KAT CAST On demand On power on or reset AES-GCM KAT CAST On demand On power on or reset AES-GCM KAT CAST On demand On power on or reset Counter DRBG KAT CAST On demand On power on or reset DSA SigGen (FIPS186-4) KAT CAST On demand On power on or reset DSA SigVer (FIPS186-4) KAT CAST On demand On power on or reset ECDSA SigGen (FIPS186-4) KAT CAST On demand On power on or reset ECDSA SigVer (FIPS186-4) KAT CAST On demand On power on or reset EDDSA ED448 SigGen KAT CAST On demand On power on or reset
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3 Algorithm or Test Test Method Test Type Period Periodic Method EDDSA ED448 SigVer KAT CAST On demand On power on or reset EDDSA ED25519 SigGen KAT CAST On demand On power on or reset EDDSA ED25519 SigVer KAT CAST On demand On power on or reset Hash DRBG KAT CAST On demand On power on or reset HMAC DRBG KAT CAST On demand On power on or reset HMAC-SHA2-256 KAT CAST On demand On power on or reset KAS-ECC-SSC Sp800-56Ar3 KAT CAST On demand On power on or reset KAS-FFC-SSC Sp800-56Ar3 KAT CAST On demand On power on or reset KAS-IFC-SSC KAT CAST On demand On power on or reset KAS-KDF OneStep SP800-56Cr2 KAT CAST On demand On power on or reset KAS-KDF TwoStep SP800-56Cr2 KAT CAST On demand On power on or reset KDF ANS 9.42 KAT CAST On demand On power on or reset KDF ANS 9.63 KAT CAST On demand On power on or reset KDF SP800-108 KAT CAST On demand On power on or reset KDF SSH KAT CAST On demand On power on or reset KTS-IFC KAT CAST On demand On power on or reset KTS-IFC KAT CAST On demand On power on or reset KTS-IFC KAT CAST On demand On power on or reset PBKDF KAT CAST On demand On power on or reset RSA SigGen (FIPS186-4) KAT CAST On demand On power on or reset RSA SigVer (FIPS186-4) KAT CAST On demand On power on or reset SHA-1 KAT CAST On demand On power on or reset SHA2-512 KAT CAST On demand On power on or reset SHA3-256 KAT CAST On demand On power on or reset TLS v1.2 KDF RFC7627 KAT CAST On demand On power on or reset TLS v1.3 KDF KAT CAST On demand On power on or reset DSA KeyGen (FIPS186-4) PCT PCT On demand On power on or reset ECDSA KeyGen (FIPS186-4) PCT PCT On demand On power on or reset EDDSA KeyGen PCT PCT On demand On power on or reset RSA KeyGen (FIPS186-4) PCT PCT On demand On power on or reset Table 20: Conditional Periodic Information
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
Name Description Conditions Recovery Method Indicator Self-test The self-test failure error If one of the KATs fails or integrity test Reload the Module into PROV_R_FIPS_MODULE_IN_ERROR_STATE failure state fails memory Table 21: Error States
Each time the Module is powered up it tests that the cryptographic algorithms still operate correctly and that sensitive data has not been damaged. The pre-operational self-tests are available on demand by reloading the Module. On instantiation, the Module performs the pre-operational self-test and all CASTs. All KATs must complete successfully prior to any other use of cryptography by the Module. The fips_self_test function (inclusive of software integrity verification) can also be called on demand, fulfilling AS05.11.
During the manufacturing process, ICU Medical executes the build and installation instructions for the Module. The Module is pre-installed and configured in supported ICU Medical solutions. The approved mode is enabled by default. There are no additional installation, configuration, or usage instructions for operators intending to use the Module.
Guidance Documentation is inclusive of all information required per ISO/IEC 19790:2012 Section 7.11.9.
The inherent properties of the Module are:
FIPS 140-3 Security Policy ICU Medical FIPS Module for OpenSSL 3
The Module implements mitigations for constant-time implementations and blinding attacks.
Constant-time implementations protect cryptographic implementations in the Module against timing analysis since such attacks exploit differences in execution time depending on the cryptographic operation, and constant-time implementations ensure that the variations in execution time cannot be traced back to the key, CSP or secret data. Numeric blinding protects the RSA, DSA and ECDSA algorithms from timing attacks. These algorithms are vulnerable to such attacks since attackers can measure the time of signature operations or RSA decryption. To mitigate this, the Module generates a random blinding factor which is provided as an input to the decryption/signature operation and is discarded once the operation has completed and resulted in an output. This makes it difficult for attackers to attempt timing attacks on such operations without the knowledge of the blinding factor, and therefore the execution time cannot be correlated to the RSA/DSA/ECDSA key.
The mitigation mechanisms described in Section 12.2 are inherent within the validated algorithms. No other guidance or constraints are specified.