Masimo Cryptographic Module

Certificate

Approved Algorithms (63)

Derived Review-Risk Graph (review prompts, not findings)

flowchart LR
  %% Deterministic review-risk graph for Masimo Cryptographic Module
  %% Review prompts and evidence gaps, NOT vulnerability findings.
  subgraph CMVP["CMVP-disclosed clues"]
    C3["[low] Self-test / status surface<br/>(referenced in text)<br/><i>Self-Test<br/>Status Output</i>"]
    C5["[low] Protocol / secure-channel<br/>references (may be KDF<br/>names, not a live channel)<br/><i>TLS<br/>HTTPS<br/>library named: openssl</i>"]
    C6["[low] Operating system / runtime<br/>referenced (boundary<br/>membership not asserted)<br/><i>operating system<br/>linux<br/>kernel</i>"]
  end
  subgraph Inference["Derived inference"]
    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"]
    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"]
    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
  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 C3,C5,C6 clue;
  class I3,I5,I6 infer;
  class R3,R5,R6 risk;
  class E3,E5,E6 evidence;

flowchart LR
  %% Deterministic clue tier for Masimo Cryptographic Module
  %% confidence: high = structured record field; medium = structured but soft; low (dashed) = bare keyword hit, context unverified
  subgraph CMVP["CMVP-disclosed clues (deterministic)"]
    C3["[low] Self-test / status surface (referenced in text)<br/><i>Self-Test<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/>HTTPS<br/>library named: openssl</i><br/>src: text:keyword"]
    C6["[low] Operating system / runtime referenced (boundary membership not asserted)<br/><i>operating system<br/>linux<br/>kernel</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 C3,C5,C6 clueLow;

Security Policy, page by page

Masimo Corporation Masimo Cryptographic Module Software Version: 1.0 FIPS Security Level: 1 Document Version: 0.2 Prepared for: Prepared by: Masimo Corporation Corsec Security, Inc.

Irvine, CA 92618 Fairfax, VA 22033 United States of America United States of America Phone: +1 800 326 4890 Phone: +1 703 267 6050 www.masimo.com www.corsec.com

Abstract This is a non-proprietary Cryptographic Module Security Policy for the Masimo Cryptographic Module (software version: 1.0) from Masimo Corporation (Masimo). This Security Policy describes how the Masimo Cryptographic Module meets the security requirements of Federal Information Processing Standards (FIPS) Publication 140-3, which details the U.S. and Canadian government requirements for cryptographic modules. More information about the FIPS 140-3 standard and validation program is available on the Cryptographic Module Validation Program (CMVP) website, which is maintained by the National Institute of Standards and Technology (NIST) and the Canadian Centre for Cyber Security (CCCS). This document also describes how to run the module in an Approved mode of operation. This policy was prepared as part of the Level 1 FIPS 140-3 validation of the module. The Masimo Cryptographic Module is referred to in this document as Masimo Crypto Module or the module. References This document deals only with operations and capabilities of the module in the technical terms of a FIPS 140-3 cryptographic module security policy. More information is available on the module from the following sources:

• The Masimo website (www.masimo.com) contains information on the full line of products from Masimo.
• The search page on the CMVP website (https://csrc.nist.gov/Projects/cryptographic-module-validationprogram/Validated-Modules/Search) can be used to locate and obtain vendor contact information for technical or sales-related questions about the module. Document Organization ISO/IEC 19790 Annex B uses the same section naming convention as ISO/IEC 19790 section 7 - Security requirements. For example, Annex B section B.2.1 is named “General” and B.2.2 is named “Cryptographic module specification,” which is the same as ISO/IEC 19790 section 7.1 and section 7.2, respectively. Therefore, the format of this Security Policy is presented in the same order as indicated in Annex B, starting with “General” and ending with “Mitigation of other attacks.” If sections are not applicable, they have been marked as such in this document. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

1. General Masimo Corporation is a global medical technology company that develops and produces a wide array of industryleading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo’s Root® Patient Monitoring and Connectivity Platform was built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies. When connected to Masimo’s Radical-7 Pulse CO-Oximeter®, Root provides continuous monitoring using industryleading Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry. In addition, the platform can be upgraded to provide Masimo rainbow SET® technology, allowing clinicians to non-invasively monitor multiple additional physiologic parameters. The Masimo Cryptographic Module v1.0 is a software library providing a C language API 1 for use by Masimo products requiring cryptographic functionality. The Masimo Cryptographic Module v1.0 includes symmetric encryption/decryption, digital signature generation/verification, hashing, cryptographic key generation, random number generation, message authentication, and SSP establishment functions to secure data-at-rest/data-inflight and offers cryptographic support for secure communications protocols (including TLS2 1.2/1.3). The Masimo Cryptographic Module is validated at the FIPS 140-3 section levels shown in Table
2. Table 1 – Security Levels ISO/IEC 24579 Section
3. FIPS 140-3 Section Title Security Level [Number Below]

1 General 1

2 Cryptographic Module Specification 1

3 Cryptographic Module Interfaces 1

4 Roles, Services, and Authentication 1

5 Software/Firmware Security 1

6 Operational Environment 1

7 Physical Security N/A

8 Non-Invasive Security N/A

9 Sensitive Security Parameter Management 1

10 Self-tests 1

11 Life-Cycle Assurance 1

12 Mitigation of Other Attacks N/A

The module has an overall security level of 1. API

• Application Programming Interface

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

2. Cryptographic Module Specification The Masimo Cryptographic Module v1.0 is a software module with a multi-chip standalone embodiment. The module is designed to operate within a modifiable operational environment.

The module was tested and found to be compliant with FIPS 140-3 requirements on the environments listed in Table 2. Table 2

• Tested Operational Environments # Operating System Hardware Platform Processor PAA/Acceleration

1 Custom Linux OS with Linux Masimo Radical-7 ARM Cortex-A8 (ARMv7-A) Without PAA

2 Custom Linux OS with Linux Masimo Root ARM Cortex-A8 (ARMv7-A) Without PAA

kernel 4.9.43 The vendor affirms the module’s continued validation compliance when operating on the environments listed in Table 3. Table 3

• Vendor-Affirmed Operational Environments # Operating System Hardware Platform

1 Red Hat Enterprise Linux 8 Masimo Patient SafetyNet

3 Windows 10 Pro on VMware Workstation 15.x Masimo Patient SafetyNet View Station

8 Custom Linux OS using Yocto standard Masimo iSirona Connectivity Hub

9 Android 6.0.1 Masimo Uniview Media Hub

10 Android 7.0 Masimo Uniview 60 Tablet

11 Android 12.0 Masimo Zebra TC51-HC Phone

12 Custom Linux OS with Linux kernel 4.14.78 Masimo Radical-7 w/ ARM Cortex-A9 (ARMv7-A)

13 Custom Linux OS with Linux kernel 4.14.78 Masimo Root w/ ARM Cortex-A9 (ARMv7-A)

The cryptographic module maintains compliance when operating on a general-purpose computer (GPC) with any of the following supported bare metal and virtual environments: Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

• Red Hat Enterprise Linux 8 on VMware ESXi 5.x and 6.x
• Red Hat Enterprise Linux 8 on Linux KVM 7
• Windows Server 2019 on VMware ESXi 6.x
• Windows 10 Pro on VMware Workstation 15.x
• Android 5.x
• 12.x The cryptographic module also maintains validation compliance when operating on any GPC provided that the GPC uses any single-user operating system/mode specified on the validation certificate, or another compatible single-user operating system. The CMVP makes no statement as to the correct operation of the module or the security strengths of the generated keys when ported to an operational environment not listed on the validation certificate.

Validation certificates for each Approved security function are listed in Table 4. Note that there are algorithms, modes, and key/moduli sizes that have been CAVP-tested but are not used by any Approved service of the module. Only the algorithms, modes/methods, and key lengths/curves/moduli shown in Table 4 are used by an Approved service of the module. Table 4

• Approved Algorithms CAVP Algorithm and Mode / Method Description / Key Size(s) / Use / Function Certificate Standard Key Strengths A3595 AES CBC4, CFB15, CFB8, 128, 192, 256 Encryption/decryption FIPS PUB3 197 CFB128, CTR6, ECB7, OFB8 NIST SP 800-38A A3595 AES CMAC9 128, 192, 256 MAC generation/verification NIST SP 800-38B A3595 AES CCM10 128, 192, 256 Encryption/decryption NIST SP 800-38C A3595 AES GCM11 (internal IV) 128, 192, 256 Encryption/decryption NIST SP 80- 38D A3595 AES GMAC12 128, 192, 256 Encryption/decryption NIST SP 80- 38D A3595 AES XTS13,14,15 128, 256 Encryption/decryption NIST SP 800-38E

CMAC

• Cipher-Based Message Authentication Code

XEX

• XOR Encrypt XOR

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

CAVP Algorithm and Mode / Method Description / Key Size(s) / Use / Function Certificate Standard Key Strengths A3595 AES KW16, KWP17 128, 192, 256 Encryption/decryption NIST SP 800-38F A3595 CVL18 TLS v1.2 KDF RCF7627 - Key derivation RFC19 7627 No part of the TLS v1.2 protocol, other than the KDF, has been tested by the CAVP and CMVP. A3596 CVL TLS v1.3 KDF - Key derivation RFC 8446 No part of the TLS v1.3 protocol, other than the KDF, has been tested by the CAVP and CMVP. A3595 DRBG20 Counter-based AES-128, AES-192, AES-256 Deterministic random bit NIST SP 800-90Arev1 generation A3595 DSA21 - 2048/224, 2048/256, Domain parameter generation FIPS PUB 186-4 3072/256 (SHA2-224, SHA2-256, SHA2-384, SHA2-512) - 1024/160, 2048/224, Domain parameter verification 2048/256, 3072/256 (SHA1, SHA2-224, SHA2-256, SHA2-384, SHA2-512) - 2048/224, 2048/256, Key pair generation 3072/256 - 2048/224, 2048/256, Digital signature generation 3072/256 (SHA2-224, SHA2-256, SHA2-384, SHA2-512) - 1024/160, 2048/224, Digital signature verification 2048/256, 3072/256 (SHA1, SHA2-224, SHA2-256, SHA2-384, SHA2-512) A3595 ECDSA22 Secrets generation mode: B-233, B-283, B-409, B-571, Key pair generation FIPS PUB 186-4 Testing candidates K-233, K-283, K-409, K-571, P-224, P-256, P-384, P-521 - B-163, B-233, B-283, B-409, Public key validation B-571, K-163, K-233, K-283, K-409, K-571, P-192, P-224, P-256, P-384, P-521 KW

• Key Wrap

DSA

• Digital Signature Algorithm

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

CAVP Algorithm and Mode / Method Description / Key Size(s) / Use / Function Certificate Standard Key Strengths - B-233, B-283, B-409, B-571, Digital signature generation K-233, K-283, K-409, K-571, P-224, P-256, P-384, P-521 (SHA2-224, SHA2-256, SHA2-384, SHA2-512) - B-163, B-233, B-283, B-409, Digital signature verification B-571, K-163, K-233, K-283, K-409, K-571, P-192, P-224, P-256, P-384, P-521 (SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512) A3595 HMAC SHA-1, SHA2-224, SHA2- - Message authentication FIPS PUB 198-1 256, SHA2-384, SHA2-512, SHA3-224, SHA3-256, SHA3-384, SHA3-512 A3595 KAS23 KAS-ECC-SSC with KDFs B-233, B-283, B-409, B-571, Key agreement A3596 NIST SP 800-56Arev3 (TLS 1.2 RFC7627, TLS 1.3) K-233, K-283, K-409, K-571, P-224, P-256, P-384, P-521 SSP establishment methodology provides between 112 and 256 bits of encryption strength. KAS-FFC-SSC with KDFs FB, FC Key agreement (TLS 1.2 RFC7627, TLS 1.3) SSP establishment methodology provides

A3595 KAS-ECC-SSC24 ephemeralUnified B-233, B-283, B-409, B-571, Shared secret computation25 NIST SP 800-56Arev3 K-233, K-283, K-409, K-571, P-224, P-256, P-384, P-521 A3595 KAS-FFC-SSC26 dhEphem FB, FC Shared secret computation27 NIST SP 800-56Arev3 A3595 KTS AES-CCM 128, 192, 256 Key wrap/unwrap (authenticated NIST SP 800-38C encryption)28 SSP establishment methodology provides between 128 and 256 bits of encryption strength A3595 KTS AES-GCM 128, 192, 256 Key wrap/unwrap (authenticated NIST SP 800-38D encryption)29 SSP establishment methodology provides between 128 and 256 bits of encryption strength KAS

• Key Agreement Scheme

24 KAS-ECC-SSC

• Key Agreement Scheme - Elliptic Curve Cryptography - Shared Secret Computation

25 Key agreement method complies with FIPS 140-3 Implementation Guidance D.F, scenario 2(1).

26 KAS-FFC-SSC

• Key Agreement Scheme - Finite Field Cryptography - Shared Secret Computation

27 Key agreement method complies with FIPS 140-3 Implementation Guidance D.F, scenario 2(1).

Per FIPS 140-3 Implementation Guidance D.G, AES-CCM is an Approved key transport technique.

29 Per FIPS 140-3 Implementation Guidance D.G, AES-GCM is an Approved key transport technique.

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

CAVP Algorithm and Mode / Method Description / Key Size(s) / Use / Function Certificate Standard Key Strengths A3595 KTS30 AES key wrap 128, 192, 256 Key wrap/unwrap NIST SP 800-38F SSP establishment methodology provides between 128 and 256 bits of encryption strength A3595 KTS AES with CMAC 128, 192, 256 Key wrap/unwrap (encryption with FIPS PUB 197 message authentication)31 NIST SP 800-38B SSP establishment methodology provides between 128 and 256 bits of encryption strength A3595 KTS AES with GMAC 128, 192, 256 Key wrap/unwrap (encryption with FIPS PUB 197 message authentication)32 NIST SP 800-38D SSP establishment methodology provides between 128 and 256 bits of encryption strength A3595 KTS AES-CBC with HMAC 128, 192, 256 Key wrap/unwrap (encryption with FIPS PUB 197 message authentication)33 FIPS PUB 198-1 SSP establishment methodology provides between 128 and 256 bits of encryption strength A3595 KTS Triple-DES with CMAC 112 (KO2), 168 (KO1) Key unwrap (encryption with NIST SP 800-67rev2 message authentication)34 NIST SP 800-38B A3595 KTS Triple-DES with HMAC 112 (KO2), 168 (KO1) Key unwrap (encryption with NIST SP 800-67rev2 message authentication)35 FIPS PUB 198-1 SSP establishment methodology provides

A3595 PBKDF236 Section 5.4, option 1a SHA-1, SHA2-224, SHA2- Password-based key derivation NIST SP 800-132 256, SHA2-384, SHA2-512, SHA3-224, SHA3-256, SHA3-384, SHA3-512 A3595 RSA Key generation mode: 2048, 3072, 4096 Key pair generation FIPS PUB 186-4 B.3.3 ANSI37 X9.31 2048, 3072, 4096 (SHA2- Digital signature generation 256, SHA2-384, SHA2-512) 1024, 2048, 3072, 4096 Digital signature verification (SHA-1, SHA2-256, SHA2384, SHA2-512)

Per FIPS 140-3 Implementation Guidance D.G, AES with CMAC is an Approved key transport technique.

32 Per FIPS 140-3 Implementation Guidance D.G, AES with GMAC is an Approved key transport technique.

33 Per FIPS 140-3 Implementation Guidance D.G, AES with HMAC is an Approved key transport technique.

34 Per FIPS 140-3 Implementation Guidance D.G, Triple-DES with CMAC is an Approved key transport technique.

35 Per FIPS 140-3 Implementation Guidance D.G, Triple-DES with HMAC is an Approved key transport technique.

PBKDF2

• Password-based Key Derivation Function 2

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

CAVP Algorithm and Mode / Method Description / Key Size(s) / Use / Function Certificate Standard Key Strengths PKCS#1 v1.5 2048, 3072, 4096 (SHA2- Digital signature generation 224, SHA2-256, SHA2-384, SHA2-512) 1024, 2048, 3072, 4096 Digital signature verification (SHA-1, SHA2-224, SHA2256, SHA2-384, SHA2-512) PSS38 2048, 3072, 4096 (SHA2- Digital signature generation 224, SHA2-256, SHA2-384, SHA2-512) 1024, 2048, 3072, 4096 Digital signature verification (SHA-1, SHA2-224, SHA2256, SHA2-384, SHA2-512) A3595 SHA-3 SHA3-224, SHA3-256, - Message digest FIPS PUB 202 SHA3-384, SHA3-512 A3595 SHAKE39 SHAKE-128, SHAKE-256 - Message digest FIPS PUB 202 A3595 SHS40 SHA-1, SHA2-224, SHA2- - Message digest FIPS PUB 180-4 256, SHA2-384, SHA2-512 A3595 Triple-DES CBC, CFB1, CFB8, CFB64, 168 (KO1) Decryption NIST SP 800-67rev2 ECB, OFB NIST SP 800-38A A3595 Triple-DES CMAC 112 (KO2), 168 (KO1) MAC verification NIST SP 800-67rev2 NIST SP 800-38B The module implements the non-Approved but allowed algorithms shown in Table 5 below. Table 5

• Non-Approved Algorithms Allowed in the Approved Mode of Operation Algorithm Caveat Use / Function AES (Cert. A3595) - Key unwrapping (using any approved mode) Triple-DES (Cert. A3595) - Key unwrapping (using any approved mode with two-key or three-key) The module does not implement any non-Approved algorithms allowed in the Approved mode of operation for which no security is claimed. The module employs the non-Approved algorithms shown in Table 6 below. These algorithms shall not be used in the module’s Approved mode of operation.

SHAKE

• Secure Hash Algorithm KECCAK

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Table 6

• Non-Approved Algorithms Not Allowed in the Approved Mode of Operation Algorithm / Function Use / Function AES-GCM (non-compliant when used with external IV) Authenticated encryption/decryption AES-OCB41 Authenticated encryption/decryption ANSI X9.31 RNG (with 128-bit AES core) Random number generation ARIA Encryption/decryption Blake2 Encryption/decryption Blowfish Encryption/decryption Camellia Encryption/decryption CAST, CAST5 Encryption/decryption ChaCha20 Encryption/decryption DES Encryption/decryption DH (non-compliant with untested key sizes or keys Key agreement providing less than 112 bits of encryption strength ) DRBG (non-compliant when using Hash_DRBG and Random bit generation HMAC_DRBG) DSA (non-compliant with untested key sizes or keys Key pair generation; digital signature generation; digital providing less than 112 bits of encryption strength) signature verification DSA, ECDSA, and RSA (non-compliant when used with Digital signature generation SHA-1 outside the TLS protocol) ECDH (non-compliant with curves P-192, K-163, B- Key agreement 163, and non-NIST curves) ECDSA (non-compliant with curves P-192, K-163, B- Key pair generation; digital signature generation; digital 163, and non-NIST curves) signature verification EdDSA42 Key pair generation; digital signature generation; digital signature verification IDEA Encryption/decryption KDF Key derivation functions for TLS 1.0/1.1; HKDF; KBKDF MD2, MD4, MD5 Message digest Poly1305 Message authentication code RC243, RC4, RC5 Encryption/decryption RIPEMD Message digest RMD160 Message digest RSA (non-compliant with untested key sizes or keys Key pair generation; digital signature generation; digital providing less than 112 bits of encryption strength) signature verification RSA (non-compliant with untested functions) key transport SEED Encryption/decryption

EdDSA

• Edwards-curve Digital Signature Algorithm

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Algorithm / Function Use / Function SHA-1 (non-compliant) Signature generation for TLS 1.0/1.1 SM2, SM3, SM3 Message digest SM4 Encryption/decryption Triple-DES (non-compliant) Encryption; MAC generation; key wrapping Whirlpool Message digest

As a software cryptographic module, the module has no physical components. The physical perimeter of the cryptographic module is defined by each host platform on which the module is installed. Figure 1 and Figure 2 below provide hardware block diagrams of the host devices used for testing and illustrate the module’s physical perimeter. Radio RAM Board Ethernet Serial Instrument Audio SoC w/ ARM Board I/O Processing Core USB SD Card Touch Controller Board Module Interface Touch LCD (Radical-7 Power Screen Panel Board) Interface External Power Supply KEY: BIOS

• Basic Input/Output System PCIe
• PCI express Plaintext Data CPU
• Central Processing Unit HDD
• Hard Disk Drive Encrypted Data SATA
• Serial Advanced Technology Attachment DVD
• Digital Video Disc Control Input SCSI
• Small Computer System Interface USB
• Universal Serial Bus Status Output PCI
• Peripheral Component Interconnect RAM
• Random Access Memory Physical Perimeter LED
• Light Emitting Diode LCD
• Liquid Crystal Display Figure 1
• Hardware Block Diagram (Root) Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

RAM Radio Board Serial SoC w/ ARM Processing Core Instrument Board I/O Audio Touch Controller SD Card Board Touch LCD Power Screen Panel Interface External Power Supply KEY: BIOS

• Basic Input/Output System PCIe
• PCI express Plaintext Data CPU
• Central Processing Unit HDD
• Hard Disk Drive Encrypted Data SATA
• Serial Advanced Technology Attachment DVD
• Digital Video Disc Control Input SCSI
• Small Computer System Interface USB
• Universal Serial Bus Status Output PCI
• Peripheral Component Interconnect RAM
• Random Access Memory Physical Perimeter LED
• Light Emitting Diode LCD
• Liquid Crystal Display Figure 2
• Hardware Block Diagram (Radical-7) The module’s cryptographic boundary consists of all functionalities contained within the module’s compiled source code. This comprises:
• libcrypto (cryptographic primitives library file)
• libssl (TLS protocol library file)
• libcrypto.hmac (HMAC digest file for libcrypto integrity checks)
• libssl.hmac (HMAC digest file for libssl integrity checks) The cryptographic boundary is the contiguous perimeter that surrounds all memory-mapped functionality provided by the module when loaded and stored in the host platform’s memory. The module is entirely contained within the physical perimeter. Figure 3 shows the logical block diagram of the module executing in memory and its interactions with surrounding software components, as well as the module’s physical perimeter and cryptographic boundary. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

libssl libssl.hmac Calling Application libcrypto libcrypto.hmac KEY: Cryptographic Boundary Physical Perimeter Operating System Data Input Data Output Control Input Control Output CPU Memory Storage Ports Status Output System Calls Host Device Figure 3

• Module Block Diagram (with Cryptographic Boundary)

The module supports two modes of operation: Approved and non-Approved. The module will be in its Approved mode when all pre-operational self-tests have completed successfully, and only Approved services are invoked. Table 4 and Table 5 list the Approved and allowed algorithms; Table 9 provides descriptions of the Approved services. The module alternates on a service-by-service basis between Approved and non-Approved modes of operation. The module will switch to the non-Approved mode upon execution of a non-Approved service. The module will switch back to the Approved mode upon execution of an Approved service. Table 6 lists the non-Approved algorithms implemented by the module; Table 10 below lists the services that constitute the non-Approved mode. When following the guidance in this document, CSPs are not shared between Approved and non-Approved services and modes of operation. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

3. Cryptographic Module Interfaces FIPS 140-3 defines the following logical interfaces for cryptographic modules: • Data Input • Data Output • Control Input • Control Output • Status Output As a software library, the cryptographic module has no direct access to any of the host platform’s physical ports, as it communicates only to the calling application via its well-defined API. A mapping of the FIPS-defined interfaces and the module’s ports and interfaces can be found in Table
4. Note that the module does not output control information, and thus has no specified control output interface. Table 7 – Ports and Interfaces Physical Port Logical Interface Data That Passes Over Port/Interface Physical data input port(s) of Data Input • Data to be encrypted, decrypted, signed, the tested platforms • API input arguments that provide verified, or hashed input data for processing • Keys to be used in cryptographic services • Random seed material for the module’s DRBG • Keying material to be used as input to SSP establishment services Physical data output port(s) of Data Output • Data that has been encrypted, the tested platforms • API output arguments that return decrypted, or verified generated or processed data back • Digital signatures to the caller • Hashes • Random values generated by the module’s DRBG • Keys established using module’s SSP establishment methods Physical control input port(s) of Control Input • API commands invoking cryptographic the tested platforms • API input arguments that are services used to initialize and control the • Modes, key sizes, etc. used with operation of the module cryptographic services Physical status output port(s) Status Output • Status information regarding the module of the tested platforms • API call return values • Status information regarding the invoked service/operation Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

4. Roles, Services, and Authentication The sections below describe the module’s authorized roles, services, and operator authentication methods.

The module supports two roles that authorized operators can assume:

• Crypto Officer - The CO role performs cryptographic initialization or management functions and general security services.
• User
• The User role performs general security services, including cryptographic operations and other approved security functions. The module does not support multiple concurrent operators. The calling application that loaded the module is its only operator. Table 8 below lists the supported roles, along with the services (including input and output) available to each role. Table 8
• Roles, Service Commands, Input and Output Role Service Input Output CO Show Status API call parameters Current operational status CO Perform self-tests on-demand Re-instantiate module; API call Status parameters CO Zeroize Restart calling application; reboot None or power-cycle host device CO Show versioning information API call parameters Module name, version User Perform symmetric encryption API call parameters, key, plaintext Status, ciphertext User Perform symmetric decryption API call parameters, key, Status, plaintext ciphertext User Generate symmetric digest API call parameters, key, plaintext Status, digest User Verify symmetric digest API call parameters, digest Status User Perform authenticated symmetric API call parameters, key, plaintext Status, ciphertext encryption User Perform authenticated symmetric API call parameters, key, Status, plaintext decryption ciphertext User Generate random number API call parameters Status, random bits User Perform keyed hash operations API call parameters, key, message Status, MAC44 User Perform hash operation API call parameters, message Status, hash User Generate DSA domain parameters API call parameters Status, domain parameters User Verify DSA domain parameters API call parameters Status, domain parameters User Generate asymmetric key pair API call parameters Status, key pair User Verify ECDSA public key API call parameters, key Status User Generate digital signature API call parameters, key, message Status, signature

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Role Service Input Output User Verify digital signature API call parameters, key, Status signature, message User Perform key wrap API call parameters, encryption Status, encrypted key key, key User Perform key un-encapsulation API call parameters, decryption Status, decrypted key key, key User Compute shared secret API call parameters Status, shared secret User Derive keys via TLS KDF API call parameters, TLS pre- Status, TLS keys master secret User Perform key agreement functions API call parameters Status, symmetric key User Derive key via PBKDF2 API call parameters, passphrase Status, symmetric key

The module does not support authentication methods; operators implicitly assume an authorized role based on the service selected.

Descriptions of the approved services available to the authorized roles are provided in Table 9 below. This module is a software library that provides cryptographic functionality to calling applications. As such, the security functions provided by the module are considered the module’s security services. Indicators for Approved services (in the case of this module, those security functions with algorithm validation certificates and all required self-tests) are provided via API return value. When invoking a security function, the calling application provides inputs via an internal structure, or “context”. Upon each service invocation, the module will determine if the invoked security function is an Approved service. To access the resulting value, the calling application must pass the finalized context to the indicator API associated with that security function (note the indicator check must be performed prior to any context cleanup is performed). The indicator API will return “1” to indicate the usage of an Approved service. Indicators for services providing non-Approved security functions (as well as for services not requiring an indicator) will have a value other than “1”, ensuring that the indicators for Approved services are unambiguous. Additional details on the APIs used for the Approved service indicators are provided in Appendix A below. The keys and Sensitive Security Parameters (SSPs) listed in the table indicate the type of access required using the following notation:

• G = Generate: The module generates or derives the SSP.
• R = Read: The SSP is read from the module (e.g., the SSP is output).
• W = Write: The SSP is updated, imported, or written to the module.
• E = Execute: The module uses the SSP in performing a cryptographic operation.
• Z = Zeroize: The module zeroizes the SSP. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Table 9

• Approved Services Service Description Approved Security Function(s) Keys and/or SSPs Roles Access Rights to Keys and/or SSPs Indicator Show Status Return module None None CO N/A N/A mode status Perform self- Perform pre- HMAC (Cert. A3595) HMAC key CO N/A API return tests on- operational self- SHA2-256 (Cert. A3595) value demand tests Zeroize Zeroize and de- None All SSPs CO All SSPs
• Z N/A allocate memory containing sensitive data Show Return module None None CO N/A N/A versioning versioning information information Perform Encrypt AES (Cert. A3595) AES key User AES key
• WE API return symmetric plaintext data AES XTS (Cert. A3595) AES XTS key AES XTS key
• WE value encryption Perform Decrypt AES (Cert. A3595) AES key User AES key
• WE API return symmetric ciphertext data AES XTS (Cert. A3595) AES XTS key AES XTS key
• WE value decryption Triple-DES (Cert. A3595) Triple-DES key Triple-DES key
• WE Generate Generate AES CMAC (Cert. A3595) AES CMAC key User AES CMAC key
• WE API return symmetric symmetric AES GMAC (Cert. A3595) AES GMAC key AES GMAC key
• WE value digest digest Verify Verify AES CMAC (Cert. A3595) AES CMAC key User AES CMAC key
• WE API return symmetric symmetric AES GMAC (Cert. A3595) AES GMAC key AES GMAC key
• WE value digest digest Triple-DES CMAC (Cert. A3595) Triple-DES CMAC key Triple-DES CMAC key
• WE Perform Encrypt AES GCM (Cert. A3595) AES GCM key User AES GCM key
• WE API return authenticated plaintext using AES GCM IV AES GCM IV
• WE value symmetric supplied AES encryption GCM key and IV Perform Decrypt AES GCM (Cert. A3595) AES GCM key User AES GCM key
• WE API return authenticated ciphertext using AES GCM IV AES GCM IV
• WE value symmetric supplied AES decryption GCM key and IV Generate Generate CTR_DRBG (Cert. A3595) DRBG entropy input User DRBG entropy input
• WE API return random random bits DRBG seed DRBG seed
• GE value number using DRBG DRBG ‘V’ value DRBG ‘V’ value
• GE DRBG ‘Key’ value DRBG ‘Key’ value
• GE Perform keyed Compute a HMAC (Cert. A3595) HMAC key User HMAC key
• WE API return hash message SHA-3 (Cert. A3595) value operation authentication SHS (Cert. A3595) code Perform hash Compute a SHA-3 (Cert. A3595) None User N/A API return operation message digest SHAKE (Cert. A3595) value SHS (Cert. A3595) Generate DSA Generate DSA CTR_DRBG (Cert. A3595) None User N/A API return domain domain DSA (Cert. A3595) value parameters parameters Verify DSA Verify DSA DSA (Cert. A3595) None User N/A API return domain domain value parameters parameters Generate Generate a CTR_DRBG (Cert. A3595) DSA public key User DSA public key
• GR API return asymmetric public/private DSA (Cert. A3595) DSA private key DSA private key
• GR value key pair key pair ECDSA (Cert. A3595) ECDSA public key ECDSA public key
• GR RSA (Cert. A3595) ECDSA private key ECDSA private key
• GR RSA public key RSA public key
• GR RSA private key RSA private key
• GR Verify ECDSA Verify an ECDSA ECDSA (Cert. A3595) ECDSA public key User ECDSA public key
• W API return public key public key value Generate Generate a DSA (Cert. A3595) DSA private key User DSA private key
• WE API return digital digital signature ECDSA (Cert. A3595) ECDSA private key ECDSA private key
• WE value signature RSA (Cert. A3595) RSA private key RSA private key
• WE SHS (Cert. A3595) Verify digital Verify a digital DSA (Cert. A3595) DSA public key User DSA public key
• WE API return signature signature ECDSA (Cert. A3595) ECDSA public key ECDSA public key
• WE value RSA (Cert. A3595) RSA public key RSA public key
• WE SHS (Cert. A3595) Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Service Description Approved Security Function(s) Keys and/or SSPs Roles Access Rights to Keys and/or SSPs Indicator Perform key Perform key AES (Cert. A3595) AES key User AES key

• WE API return wrap wrap AES-KW (Cert. A3595) AES CMAC key AES CMAC key
• WE value AES-KWP (Cert. A3595) AES GMAC key AES GMAC key
• WE AES-GCM (Cert. A3595) AES GCM key AES GCM key
• WE CCM (Cert. A3595) AES GCM IV AES GCM IV
• WE CMAC (Cert. A3595) HMAC key HMAC key
• WE GMAC (Cert. A3595) HMAC (Cert. A3595) Perform key Perform key AES (Cert. A3595) AES key User AES key
• WE API return unwrap unwrap AES-KW (Cert. A3595) AES CMAC key AES CMAC key
• WE value AES-KWP (Cert. A3595) AES GMAC key AES GMAC key
• WE AES-GCM (Cert. A3595) AES GCM key AES GCM key
• WE CCM (Cert. A3595) AES GCM IV AES GCM IV
• WE CMAC (Cert. A3595) HMAC key HMAC key
• WE GMAC (Cert. A3595) Triple-DES key Triple-DES key
• WE HMAC (Cert. A3595) Triple-DES (Cert. A3595) Compute Compute KAS-ECC-SSC (Cert. A3595) DH public key User DH public key
• WE API return shared secret DH/ECDH KAS-FFC-SSC (Cert. A3595) DH private key DH private key
• WE value shared secret ECDH public key ECDH public key
• WE suitable for use ECDH private key ECDH private key
• WE as input to a TLS TLS 1.2 pre-master secret TLS 1.2 pre-master secret
• G 1.2/1.3 KDF TLS 1.3 handshake secret TLS 1.3 handshake secret
• G Derive keys via Derive TLS KDF (TLS 1.2 RFC7627) (Cert. TLS 1.2 pre-master secret User TLS 1.2 pre-master secret
• WE API return TLS KDF 1.2/1.3 session A3595) TLS 1.2 master secret TLS 1.2 master secret
• GE value and integrity KDF (TLS 1.3) (Cert. A3596) TLS 1.3 handshake secret TLS 1.3 handshake secret
• GE keys TLS 1.3 handshake traffic secrets TLS 1.3 master secret
• GE TLS 1.3 master secret TLS 1.3 handshake traffic secrets
• TLS 1.3 application traffic secrets GE AES key TLS 1.3 master secret
• GE AES GCM key TLS 1.3 application traffic secrets
• AES GCM IV GE HMAC key AES key
• G AES GCM key
• G AES GCM IV
• G HMAC key
• G Perform key Establish KAS-ECC-SSC (Cert. A3595) DH public key User DH public key
• WE API return agreement symmetric key KAS-FFC-SSC (Cert. A3595) DH private key DH private key
• WE value functions using DH/ECDH KDF (TLS 1.2) (Cert. A3595) ECDH public key ECDH public key
• WE key agreement KDF (TLS 1.3) (Cert. A3596) ECDH private key ECDH private key
• WE TLS 1.2 pre-master secret TLS 1.2 pre-master secret
• GE TLS 1.2 master secret TLS 1.2 master secret
• GE TLS 1.3 handshake secret TLS 1.3 handshake secret
• GE TLS 1.3 handshake traffic secrets TLS 1.3 master secret
• GE TLS 1.3 master secret TLS 1.3 handshake traffic secrets
• TLS 1.3 application traffic secrets GE AES key TLS 1.3 master secret
• GE AES GCM key TLS 1.3 application traffic secrets
• AES GCM IV GE HMAC key AES key
• G AES GCM key
• G AES GCM IV
• G HMAC key
• G Derive key via Derive key from PBKDF (Cert. A3595) Passphrase User Passphrase– WE API return PBKDF2 PBKDF2 value * Per FIPS 140-3 Implementation Guidance 2.4.C, the Show Status, Zeroize, and Show Versioning Information services do not require an Approved security service indicator. Table 10 below lists the non-approved services available to module operators. Table 10
• Non-Approved Services Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Service Description Algorithm(s) Accessed Role Indicator Perform data encryption Perform symmetric data ARIA, Blake2, Blowfish, User API return value (non-compliant) encryption Camellia, CAST, CAST5, ChaCha20, DES, IDEA, RC2, RC4, RC5, SEED, SM4, TripleDES (non-compliant) Perform data decryption Perform symmetric data ARIA, Blake2, Blowfish, User API return value (non-compliant) decryption Camellia, CAST, CAST5, ChaCha20, DES, IDEA, RC2, RC4, RC5, SEED, SM4 Perform MAC operations Perform message Poly1305, Triple-DES/CMAC User API return value (non-compliant) authentication operations (non-compliant for MAC generation) Perform hash operation (non- Perform hash operation MD2, MD4, MD5, RIPEMD, User API return value compliant) RMD160, SM2, SM3, SM4, Whirlpool Perform digital signature Perform digital signature DSA (non-compliant), ECDSA User API return value functions (non-compliant) functions (non-compliant), RSA (noncompliant) Perform key agreement Perform key agreement DH (non-compliant), ECDH User API return value functions (non-compliant) functions (non-compliant) Perform key wrap (non- Perform key wrap functions Triple-DES/CMAC (non- User API return value compliant) compliant) Perform key encapsulation Perform key encapsulation RSA (non-compliant) User API return value (non-compliant) functions Perform key un-encapsulation Perform key un-encapsulation RSA (non-compliant) User API return value (non-compliant) functions Perform key derivation Perform key derivation HKDF (non-compliant), KBKDF User API return value functions (non-compliant) functions (non-compliant), TLS v1.0/1.1 KDF (non-compliant) Perform authenticated Perform authenticated AES-OCB User API return value encryption/decryption (non- encryption/decryption compliant) Perform random number Perform random number ANSI X9.31 RNG (with 128-bit User API return value generation (non-compliant) generation AES core), Hash_DRBG (noncompliant), HMAC_DRBG (non-compliant) Perform key pair generation Perform key pair generation DSA (non-compliant), ECDSA User API return value (non-compliant) (non-compliant), EdDSA, RSA (non-compliant) Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

5. Software/Firmware Security All software components within the cryptographic boundary are verified using an Approved integrity technique implemented within the cryptographic module itself. The module implements independent HMAC SHA2-256 digest checks to test the integrity of each library file; failure of the integrity test for either library file will cause the module to enter a critical error state. The module’s integrity check is performed automatically at module instantiation (i.e., when the module is loaded into memory for execution) without action from the module operator. The CO can initiate the pre-operational tests on demand by re-instantiating the module or issuing the FIPS_selftest() API command. The Masimo Cryptographic Module is not delivered to end-users as a standalone offering. Rather, it is a pre-built component integrated into Masimo’s application software. Masimo does not provide end-users with any mechanisms to directly access the module, its source code, its APIs, or any information sent to/from the module. Thus, end-users have no ability to independently load the module onto target platforms. No configuration steps are required to be performed by end-users, and no end-user action is required to initialize the module for operation. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

6. Operational Environment The Masimo Cryptographic Module comprises a software cryptographic library that executes in a modifiable operational environment. The cryptographic module has control over its own SSPs. The process and memory management functionality of the host device’s OS prevents unauthorized access to plaintext private and secret keys, intermediate key generation values and other SSPs by external processes during module execution. The module only allows access to SSPs through its well-defined API. The operational environment provides the capability to separate individual application processes from each other by preventing uncontrolled access to CSPs and uncontrolled modifications of SSPs regardless of whether this data is in the process memory or stored on persistent storage within the operational environment. Processes that are spawned by the module are owned by the module and are not owned by external processes/operators. Please refer to section 2.1 of this document for a list/description of the applicable operational environments. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

7. Physical Security This section is not applicable. Per section 7.7.1 of ISO/IEC 19790:2021, the requirements of this section are “applicable to hardware and firmware modules, and hardware and firmware components of hybrid modules”. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

8. Non-Invasive Security This section is not applicable. There are currently no approved non-invasive mitigation techniques referenced in ISO/IEC 19790:2021 Annex F. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

9. Sensitive Security Parameter Management

The module supports the keys and other SSPs listed Table 11. Note that all SSP import and export is electronic and is performed within the Tested OE’s Physical Perimeter (TOEPP). Table 11

• SSPs Key/SSP Strength Security Function Generation Import / Export Establishment Storage Zeroization Use & Related Name/Type and Cert. Number Keys Keys AES key Between 128 AES (CBC, CCM, - Imported in Derived via Not Reboot or power- Symmetric (CSP) and 256 bits CFB, CTR, ECB, plaintext via API TLS KDFs persistently cycle the host encryption, OFB, KW, KWP parameter stored by the device decryption; modes) module key transport (Cert. A3595) Never exported KTS (Cert. A3595) AES GCM key Between 128 AES (GCM mode) - Imported in Derived via Not Reboot or power- Authenticated (CSP) and 256 bits (Cert. A3595) plaintext via API TLS KDFs persistently cycle the host symmetric parameter stored by the device encryption, KTS module decryption; (Cert. A3595) Never exported key transport AES XTS key 256 bits AES (XTS mode) - Imported in - Not Reboot or power- Symmetric (CSP) (Cert. A3595) plaintext via API persistently cycle the host encryption, parameter stored by the device decryption module Never exported AES CMAC key Between 128 AES (CMAC mode) - Imported in - Not Reboot or power- MAC (CSP) and 256 bits (Cert. A3595) plaintext via API persistently cycle the host generation, parameter stored by the device verification KTS module (Cert. A3595) Never exported AES GMAC key Between 128 AES (GMAC - Imported in - Not Reboot or power- MAC (CSP) and 256 bits mode) plaintext via API persistently cycle the host generation, (Cert. A3595) parameter stored by the device verification module KTS Never exported (Cert. A3595) Triple-DES key - Triple-DES - Imported in - Not Reboot or power- Symmetric (CSP) (Cert. A3595) plaintext via API persistently cycle the host decryption; parameter stored by the device key KTS module unwrapping (Cert. A3595) Never exported Triple-DES - Triple-Des (CMAC - Imported in - Not Reboot or power- MAC CMAC key mode) plaintext via API persistently cycle the host verification (CSP) (Cert. A3595) parameter stored by the device module Never exported HMAC key 112 bits HMAC - Imported in Derived via Not Reboot or power- Keyed hash (CSP) (minimum) (Cert. A3595) plaintext via API TLS KDFs persistently cycle the host parameter stored by the device KTS module (Cert. A3595) Never exported Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Key/SSP Strength Security Function Generation Import / Export Establishment Storage Zeroization Use & Related Name/Type and Cert. Number Keys DSA private 112 or 128 bits DSA Generated Imported in - Not Reboot or power- Digital key (Cert. A3595) internally via plaintext via API persistently cycle the host signature (CSP) approved parameter stored by the device generation DRBG module Exported in plaintext via API parameter DSA public key 112 or 128 bits DSA Generated Imported in - Not Reboot or power- Digital (PSP) (Cert. A3595) internally via plaintext via API persistently cycle the host signature approved parameter stored by the device verification DRBG module Exported in plaintext via API parameter ECDSA private Between 112 ECDSA Generated Imported in - Not Reboot or power- Digital key and 256 bits (Cert. A3595) internally via plaintext via API persistently cycle the host signature (CSP) approved parameter stored by the device generation DRBG module Exported in plaintext via API parameter ECDSA public Between 112 ECDSA Generated Imported in - Not Reboot or power- Digital key and 256 bits (Cert. A3595) internally via plaintext via API persistently cycle the host signature (PSP) approved parameter stored by the device verification DRBG module Exported in plaintext via API parameter RSA private Between 112 RSA Generated Imported in - Not Reboot or power- Digital key and 150 bits (Cert. A3595) internally via plaintext via API persistently cycle the host signature (CSP) approved parameter stored by the device generation KTS DRBG module (Cert. A3595) Exported in plaintext via API parameter RSA public key Between 80 RSA Generated Imported in - Not Reboot or power- Digital (PSP) and 150 bits (Cert. A3595) internally via plaintext via API persistently cycle the host signature approved parameter stored by the device verification KTS DRBG module (Cert. A3595) Exported in plaintext via API parameter DH private key 112 bits KAS-SSC-FFC Generated Imported in - Not Reboot or power- DH shared (CSP) (Cert. A3595) internally via plaintext via API persistently cycle the host secret approved parameter stored by the device computation DRBG module Exported in plaintext via API parameter DH public key 112 bits KAS-SSC-FFC Generated Imported in - Not Reboot or power- DH shared (PSP) (Cert. _A3595) internally via plaintext via API persistently cycle the host secret approved parameter stored by the device computation DRBG module Exported in plaintext via API parameter ECDH private Between 112 KAS-SSC-ECC Generated Imported in - Not Reboot or power- ECDH shared key and 256 bits (Cert. A3595) internally via plaintext via API persistently cycle the host secret (CSP) approved parameter stored by the device computation DRBG module Exported in plaintext via API parameter ECDH public Between 112 KAS-SSC-ECC Generated Imported in - Not Reboot or power- ECDH shared key and 256 bits (Cert. A3595) internally via plaintext via API persistently cycle the host secret (PSP) approved parameter stored by the device computation DRBG module Exported in plaintext via API parameter Other SSPs Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Key/SSP Strength Security Function Generation Import / Export Establishment Storage Zeroization Use & Related Name/Type and Cert. Number Keys Passphrase - PBKDF - Imported in - Not Reboot or power- Input to PBKDF (PSP) (Cert. A3595) plaintext via API persistently cycle the host for key parameter stored by the device derivation module Never exported AES GCM IV - AES (GCM mode) Generated - - Not Reboot or power- Initialization (CSP) (Cert. A3595) internally in persistently cycle the host vector for AES compliance stored by the device GCM with the module provisions of a peer-to-peer industry standard protocols TLS 1.2 pre- - KDF (TLS 1.2 - Imported in - Not Reboot or power- Input to TLS master secret RFC7627) plaintext via API persistently cycle the host 1.2 KDF for (CSP) (Cert. A3595) parameter stored by the device derivation of module secrets and Never exported keys TLS 1.2 master - KDF (TLS 1.2 - - Derived Not Reboot or power- Derivation of secret RFC7627) internally via persistently cycle the host keys used for (CSP) (Cert. A3595) TLS 1.2 KDF stored by the device securing TLS with EMS45 module 1.2 session extension traffic TLS 1.3 - KDF (TLS 1.3) - Imported in - Not Reboot or power- Input to TLS handshake (Cert. A3596) plaintext via API persistently cycle the host 1.3 KDF for secret parameter stored by the device derivation of (CSP) module secrets and Never exported keys TLS 1.3 - KDF (TLS 1.3) - - Derived Not Reboot or power- Derivation of handshake (Cert. A3596) internally via persistently cycle the host keys used for traffic secrets TLS 1.3 KDF stored by the device securing TLS (CSP) module 1.3 handshake traffic TLS 1.3 master - KDF (TLS 1.3) - - Derived Not Reboot or power- Derivation of secret (Cert. A3596) internally via persistently cycle the host TLS 1.3 (CSP) TLS 1.3 KDF stored by the device application module traffic secrets TLS 1.3 - KDF (TLS 1.3) - - Derived Not Reboot or power- Derivation of application (Cert. A3596) internally via persistently cycle the host keys used for traffic secrets TLS 1.3 KDF stored by the device securing TLS (CSP) module 1.3 session traffic DRBG entropy - DRBG - Imported in - Not Reboot or power- Entropy input (Cert. A3595) plaintext via API persistently cycle the host material for (CSP) parameter46 stored by the device DRBG module Never exported DRBG seed - DRBG Generated - - Not Reboot or power- Seeding (CSP) (Cert. A3595) internally persistently cycle the host material for using nonce stored by the device DRBG along with module DRBG entropy input DRBG ‘V’ value - DRBG Generated - - Not Reboot or power- State values (CSP) (Cert. A3595) internally persistently cycle the host for DRBG stored by the device module DRBG ‘Key’ - DRBG Generated - - Not Reboot or power- State values value (Cert. A3595) internally persistently cycle the host for DRBG (CSP) stored by the device module

The module obtains entropy input from the calling application (which is outside of the cryptographic boundary) but exercises no control over the amount or the quality of the obtained entropy. As such, there is no assurance of the minimum strength of generated keys. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

The module implements the following Approved DRBG:

• Counter-based DRBG This DRBG is used to generate random values at the request of the calling application. Outputs from this DRBG are also used as seeds in the generation of asymmetric key pairs. The module implements the following non-Approved DRBGs (which are only available in the non-Approved mode of operation):
• Hash-based DRBG (non-compliant)
• HMAC-based DRBG (non-compliant)
• ANSI X9.31 RNG (non-Approved)

There is no mechanism within the module’s cryptographic boundary for the persistent storage of SSPs. The module stores DRBG state values for the lifetime of the DRBG instance. The module uses SSPs passed in on the stack by the calling application and does not store these SSPs beyond the lifetime of the API call.

Maintenance, including protection and zeroization, of any keys and CSPs that exist outside the module’s cryptographic boundary are the responsibility of the end-user. For the zeroization of keys in volatile memory, module operators can reboot/power-cycle the host device.

The cryptographic module’s entropy scheme follows the scenario given in FIPS 140-3 Implementation Guidance 9.3.A, section 2(b). The module invokes a GET command to obtain entropy for random number generation (the module requests 256 bits of entropy from the calling application per request), and then passively receives entropy from the calling application while having no knowledge of the entropy source and exercising no control over the amount or the quality of the obtained entropy. The calling application and its entropy sources are located within the physical perimeter of the module’s operational environment but outside its cryptographic boundary. Thus, there is no assurance of the minimum strength of the generated SSPs. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

10. Self-Tests Both pre-operational and conditional self-tests are performed by the module. Pre-operational tests are performed between the time the cryptographic module is instantiated and before the module transitions to the operational state. Conditional self-tests are performed by the module during module operation when certain conditions exist. The following sections list the self-tests performed by the module, their expected error status, and the error resolutions.

The module performs the following pre-operational self-test(s):

• Software integrity test for libcrypto (using an HMAC SHA2-256 digest)
• Software integrity test for libssl (using an HMAC SHA2-256 digest)

The module performs the following conditional self-tests:

• Conditional cryptographic algorithm self-tests (CASTs)
• AES ECB encrypt KAT47 (128-bit)
• AES ECB decrypt KAT (128-bit)
• AES CCM encrypt KAT (192-bit)
• AES CCM decrypt KAT (192-bit)
• AES GCM encrypt KAT (128-bit)
• AES GCM decrypt KAT (128-bit)
• AES XTS encrypt KAT (128/256-bit)
• AES XTS decrypt KAT (128/256-bit)
• AES CMAC generate KAT (CBC mode; 128/192/256-bit)
• AES CMAC verify KAT (CBC mode; 128/192/256-bit)
• Triple-DES ECB encrypt KAT (3-Key)
• Triple-DES ECB decrypt KAT (3-Key)
• Triple-DES CMAC generate KAT (CBC mode; 3-Key)
• Triple-DES CMAC verify KAT (CBC mode; 3-Key)
• CTR_DRBG generate/instantiate/reseed health checks (256-bit AES)
• DSA sign KAT (2048-bit; SHA2-256)
• DSA verify KAT (2048-bit; SHA2-256)
• ECDSA sign KAT (P-224 and K-233 curves; SHA2-256)
• ECDSA verify KAT (P-224 and K-233 curves; SHA2-256)
• RSA sign KAT (2048-bit; SHA2-256; PKCS#1.5 scheme)
• RSA verify KAT (2048-bit; SHA2-256; PKCS#1.5 scheme)
• HMAC KATs (SHA-1, SHA2-224, SHA2-256, SHA2-384, SHA2-512)
• SHA-1 KAT

Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

• SHA-2 KATs (SHA2-224, SHA2-256, SHA2-384, SHA2-512)
• SHA-3 KAT (SHA3-256)
• FFC DH Shared Secret “Z” Computation KAT (2048-bit)
• ECC CDH Shared Secret “Z” Computation KAT (P-224 curve)
• PBKDF2 KAT (SHA2-256)
• TLS 1.2 KDF KAT
• TLS 1.3 KDF KAT To ensure all CASTs are performed prior to the first operational use of the associated algorithm, all CASTs are performed during the module’s initial power-up sequence. The SHA and HMAC KATs are performed prior to the pre-operational software integrity test; all other CASTs are executed after the successful completion of the software integrity test.
• Conditional pair-wise consistency tests (PCTs)
• DSA sign/verify PCT
• ECDSA sign/verify PCT
• RSA sign/verify PCT
• DH key generation PCT
• ECDH key generation PCT

The module reaches the critical error state when any self-test fails. Upon test failure, the module immediately terminates the calling application’s API call with a returned error code and sets an internal flag, signaling the error condition. For any subsequent request made by the calling application for cryptographic services, the module will return a failure indicator, thereby disabling all access to its cryptographic functions, sensitive security parameters (SSPs), and data output services while the error condition persists. To recover, the module must be re-instantiated by the calling application. If the pre-operational self-tests complete successfully, then the module can resume normal operations. If the module continues to experience self-test failures after reinitializing, then the module will not be able to resume normal operations, and the CO should contact Masimo Corporation for assistance. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

11. Life-Cycle Assurance The sections below describe how to ensure the module is operating in its validated configuration, including the following:

• Procedures for secure installation, initialization, startup, and operation of the module
• Maintenance requirements
• Administrator and non-Administrator guidance Operating the module without following the guidance herein (including the use of undocumented services) will result in non-compliant behavior and is outside the scope of this Security Policy.

The module is an integrated component of Masimo’s product application software, module operators have no ability to independently load the module onto the target platform. The module and its calling application are to be installed on a platform specified in section 2.1 or one where portability is maintained. Masimo does not provide any mechanisms to directly access the module, its source code, its APIs, or any information sent between it and other Masimo applications.

This module is designed to support Masimo applications, and these applications are the sole consumers of the cryptographic services provided by the module. No end-user action is required to initialize the module for operation; the calling application performs any actions required for module initialization. The pre-operational integrity test and conditional CASTs are performed automatically via a default entry point (DEP) when the module is loaded for execution, without any specific action from the calling application or the end-user. End-users have no means to short-circuit or bypass these actions. Failure of any of the initialization actions will result in a failure of the module to load for execution.

No startup steps are required to be performed by end-users.

There are no specific management activities required of the CO role to ensure that the module runs securely. If any irregular activity is observed, or if the module is consistently reporting errors, then Masimo Customer Support should be contacted. The following list provides additional guidance for the CO: Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

• The fips_post_status() API can be used to determine the module’s operational status. A non-zero return value indicates that the module has passed all pre-operational self-tests and is currently in its Approved mode.
• The CO can initiate the pre-operational self-tests and conditional CASTs on demand for periodic testing of the module by re-instantiating the module, rebooting/power-cycling the host device, or issuing the FIPS_selftest() API command. The OpenSSL_version() API can be used to obtain the module’s versioning information. This information will include the module name and version, which can be correlated with the module’s validation record.

The following list provides additional policies for non-Administrators:

• The module uses PBKDF2 option 1a from section 5.4 of NIST SP 800-132. The iteration count shall be selected as large as possible, as long as the time required to generate the resultant key is acceptable for module operators. The minimum iteration count shall be 1000. The length of the passphrase used in the PBKDF shall be of at least 20 characters, and shall consist of lower-case, upper-case, and numeric characters. The upper bound for the probability of guessing the value is estimated to be 1/6220 = 10-36, which is less than 2-112. As specified in NIST SP 800-132, keys derived from passphrases may only be used in storage applications.
• The length of a single data unit encrypted or decrypted with the AES-XTS shall not exceed 2²⁰ AES blocks (that is, 16MB of data per AES-XTS instance). An XTS instance is defined in section 4 of NIST SP 800-38E. The AES-XTS mode shall only be used for the cryptographic protection of data on storage devices. The AES-XTS shall not be used for other purposes, such as the encryption of data in transit. In compliance with FIPS 140-3 Implementation Guidance C.I, the module implements the check to ensure that the two AES keys used in the XTS-AES algorithm are not identical.
• AES GCM encryption is used in the context of the TLS protocol versions 1.2 and 1.3. To meet the AES GCM (key/IV) pair uniqueness requirements from NIST SP 800-38D, the module generates the IV as follows:
• For TLS v1.2, the module supports acceptable AES GCM cipher suites from section 3.3.1 of NIST SP 800-52rev2. Per scenario 1 in FIPS 140-3 IG C.H, the mechanism for IV generation is compliant with RFC 5288. The counter portion of the IV is strictly increasing. When the IV exhausts the maximum number of possible values for a given session key, a failure in encryption will occur and a handshake to establish a new encryption key will be required. It is the responsibility of the module operator (i.e., the first party, client, or server) to trigger this handshake in accordance with RFC 5246 when this condition is encountered.
• For TLS v1.3, the protocol’s implementation is contained within the boundary of the module. Per scenario 5 in FIPS 140-3 IG C.H, the AES-GCM implementation meets the NIST SP 800-38E collision Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

probability requirement, as the mechanism for IV generation is compliant with RFC 8446. The implementations of AES GCM, TLS 1.3 KDF, and all underlying algorithms, have been successfully tested for compliance with their respective specifications (see CAVP Certs. A3595 and A3596).The generated IV is only used in the context of the AES GCM encryption executing the provisions of the TLS 1.3 protocol. The module also supports internal IV generation using the module’s Approved DRBG. The IV is at least 96 bits in length per section 8.2.2 of NIST SP 800-38D. Per NIST SP 800-38D and scenario 2 of FIPS 140-3 IG C.H, the DRBG generates outputs such that the (key/IV) pair collision probability is less than 2-32. In the event that power to the module is lost and subsequently restored, the calling application must ensure that any AES-GCM keys used for encryption or decryption are re-distributed.

• The cryptographic module’s services are designed to be provided to a calling application. Excluding the use of the NIST-defined elliptic curves as trusted third-party domain parameters, all other assurances from FIPS PUB 186-4 (including those required of the intended signatory and the signature verifier) are outside the scope of the module and are the responsibility of the calling application.
• The module performs assurances for its key agreement schemes as specified in the following sections of NIST SP 800-56Arev3:
• Section 5.5.2 (for assurances of domain parameter validity)
• Section 5.6.2.1 (for assurances required by the key pair owner) Note that several of the assurances required by the key pair owner are provided by the fact that the module itself, when acting as the key pair owner, generates the key pairs. The module includes the capability to provide the required recipient assurance of public key validity specified in section 5.6.2.2 of NIST SP 800-56Arev3. However, since public keys from other modules are not received directly by this module (those keys are received by the calling application), the module has no knowledge of when a public key is received. Validation of another module’s public key is the responsibility of the calling application.
• The calling application is responsible for ensuring that CSPs are not shared between approved and nonapproved services and modes of operation.
• The calling application is responsible for using entropy sources that meet the minimum security strength of 112 bits required for the CTR_DRBG as shown in NIST SP 800-90Arev1, Table 3. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

12. Mitigation of Other Attacks The module does not claim to mitigate any attacks beyond the FIPS 140-3 Level 1 requirements for this validation. Therefore, per ISO/IEC 19790:2021 section 7.12, requirements for this section are not applicable. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Appendix A. Approved Service Indicators This appendix specifies the APIs that are externally accessible and return the Approved service indicators. Synopsis #include <openssl/service_indicator.h> #include <openssl/ssl.h> int EVP_cipher_get_service_indicator(EVP_CIPHER_CTX *ctx); int DSA_get_service_indicator(DSA * ptr_dsa, DSA_MODES_t mode); int RSA_key_get_service_indicator(RSA * ptr_rsa); int PBKDF_get_service_indicator(); int EVP_Digest_get_service_indicator(EVP_MD_CTX *ctx); int EC_key_get_service_indicator(EC_KEY *ec_key); int CMAC_get_service_indicator(CMAC_CTX *cmac_ctx, CMAC_MODE_t mode); int HMAC_get_service_indicator(HMAC_CTX *ctx); int TLSKDF_get_service_indicator(EVP_PKEY_CTX *tls_ctx); int TLS1_3_kdf_get_service_indicator(EVP_MD *md); int TLS1_3_get_service_indicator(SSL *s); int DRBG_get_service_indicator(RAND_DRBG *drbg); Description These APIs are high-level interfaces that return the Approved service indicator value based on the parameter(s) passed to them.

• EVP_cipher_get_service_indicator() is used to return the Approved service indicator status for block ciphers like AES and Triple-DES.
• DSA_get_service_indicator() is used to return the Approved service indicator status for the DSA algorithm and its modes. You must include the mode you want the indicator for, which are specified in the DSA_MODES_t enum.
• RSA_key_get_service_indicator() is used to return the Approved service indicator status for RSA algorithm and its modes.
• PBKDF_get_service_indicator() is used to return the Approved service indicator status for PBKDF usage.
• EVP_Digest_get_service_indicator() is used to return the Approved service indicator status for SHS algorithms like SHA-1 and SHAKE.
• EC_key_get_service_indicator() is used to return the Approved service indicator status for elliptic curve algorithms like ECDSA and its modes. Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

• CMAC_get_service_indicator() is used to return the Approved service indicator status for CMAC requests that use AES or 3DES. You must include the mode you want the indicator for, which are specified in the CMAC_MODE_t enum.
• HMAC_get_service_indicator() is used to return the Approved service indicator status for HMAC requests and the associated SHS algorithm.
• TLSKDF_get_service_indicator() is used to return the Approved service indicator status for TLS KDF usage excluding TLS 1.3.
• TLS1_3_kdf_get_service_indicator() is used to return the Approved service indicator status for TLS 1.3 KDF usage. This function requires the ssl.h file and is used to call the TLS1_3_get_service_indicator() function because of the SSL struct requirement. You cannot call TLS1_3_get_service_indicator() directly unless you have the SSL struct that was used.
• DRBG_get_service_indicator() is used to return the Approved service indicator status for DRBG usage. Return Values Each function returns “1” when indicating the usage of approved services and “0” for non-approved services. Notes When calling a I<get> function, always call it after the variables have been finalized but before they are freed or destroyed. Examples The code sample below provides examples of how to check the Approved service indicators for Triple-DES (3-key, in ECB mode) encryption and decryption: int 3des_indicator_test() { static EVP_CIPHER *cipher = NULL; static EVP_CIPHER_CTX *ctx; int outLen; unsigned char pltmp[8]; unsigned char citmp[8]; unsigned char key[] = { 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18, 19,20,21,22,23,24}; unsigned char plaintext[] = { 'e', 't', 'a', 'o', 'n', 'r', 'i', 's' }; cipher = EVP_des_ede3_ecb(); //Encrypt ctx = EVP_CIPHER_CTX_new(); EVP_EncryptInit_ex(ctx, cipher, NULL, key, NULL); EVP_CIPHER_CTX_set_key_length(ctx, 24); EVP_EncryptUpdate(ctx, citmp, &outLen, plaintext, 8); // Check the indicator int NID = EVP_CIPHER_CTX_nid(ctx); fprintf(stdout,"EVP_des_ede3_ecb (NID %i) encrypt indicator = %i\n", NID, EVP_cipher_get_service_indicator(ctx)); EVP_CIPHER_CTX_cleanup(ctx); Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

//Decrypt ctx = EVP_CIPHER_CTX_new(); EVP_DecryptInit_ex(ctx, cipher, NULL, key, NULL); EVP_CIPHER_CTX_set_key_length(ctx, 24); EVP_DecryptUpdate(ctx, pltmp, &outLen, citmp, 8); // Check the indicator fprintf(stdout,"EVP_des_ede3_ecb (NID %i) decrypt indicator = %i\n", NID, EVP_cipher_get_service_indicator(ctx)); EVP_CIPHER_CTX_cleanup(ctx); EVP_CIPHER_CTX_free(ctx); } Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Appendix B. Acronyms and Abbreviations Table 12 provides definitions for the acronyms and abbreviations used in this document. Table 12

• Acronyms and Abbreviations Term Definition AES Advanced Encryption Standard ANSI American National Standards Institute API Application Programming Interface CAST Cryptographic Algorithm Self-Test CBC Cipher Block Chaining CCCS Canadian Centre for Cyber Security CCM Counter with Cipher Block Chaining - Message Authentication Code CFB Cipher Feedback CMAC Cipher-Based Message Authentication Code CMVP Cryptographic Module Validation Program CO Cryptographic Officer CPU Central Processing Unit CSP Critical Security Parameter CTR Counter CVL Component Validation List DEP Default Entry Point DES Data Encryption Standard DH Diffie-Hellman DRBG Deterministic Random Bit Generator DSA Digital Signature Algorithm ECB Electronic Code Book ECC Elliptic Curve Cryptography ECC CDH Elliptic Curve Cryptography Cofactor Diffie-Hellman ECDH Elliptic Curve Diffie-Hellman ECDSA Elliptic Curve Digital Signature Algorithm EMI/EMC Electromagnetic Interference /Electromagnetic Compatibility FFC Finite Field Cryptography FIPS Federal Information Processing Standard GCM Galois/Counter Mode GMAC Galois Message Authentication Code Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Term Definition GPC General-Purpose Computer HMAC (keyed-) Hash Message Authentication Code KAS Key Agreement Scheme KAT Known Answer Test KTS Key Transport Scheme KW Key Wrap KWP Key Wrap with Padding MD Message Digest NIST National Institute of Standards and Technology OCB Offset Codebook OE Operational Environment OFB Output Feedback OS Operating System PBKDF Password-Based Key Derivation Function PCT Pairwise Consistency Test PKCS Public Key Cryptography Standard PSS Probabilistic Signature Scheme PUB Publication RC Rivest Cipher RNG Random Number Generator RSA Rivest Shamir Adleman SHA Secure Hash Algorithm SHAKE Secure Hash Algorithm KECCAK SHS Secure Hash Standard SP Special Publication TLS Transport Layer Security TOEPP Tested OE’s Physical Perimeter XEX XOR Encrypt XOR XTS XEX-Based Tweaked-Codebook Mode with Ciphertext Stealing Masimo Cryptographic Module 1.0 ©2024 Masimo Corporation

Prepared by: Corsec Security, Inc.

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