Codes and Standards Codes and Standards

ISO 15883-7:2025

Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
Published: 2025, ISO
Associated Standard: ISO 15883-7
Language: English, French
Format: PDF

ISO 11137-1:2025

Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Published: 2025, ISO
Associated Standard: ISO 11137-1
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 17665:25

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665:2024, first edition, 2024-03)
Published: 2025, CSA Group
Associated Standard: ISO 17665
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA Z317.12:25

Cleaning and disinfecting of health care facilities
Published: 2025, CSA Group
Associated Standard: Z317.12
Language: English
Format: PDF
Codes and Standards Codes and Standards

ISO 17665:2024

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
Published: 2024, ISO
Associated Standard: ISO 17665
Language: English, French
Format: PDF
Amendments, Redlines, Supplementary Amendments, Redlines, Supplementary

ISO 11139:2018/Amd 1:2024

Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards — Amendment 1: Amended and additional terms and definitions
Published: 2024, ISO
Associated Standard: ISO 11139
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

ISO 15883-1:2024

Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
Published: 2024, ISO
Associated Standard: ISO 15883-1
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

ISO 15883-2:2024

Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
Published: 2024, ISO
Associated Standard: ISO 15883-2
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

ISO 15883-3:2024

Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
Published: 2024, ISO
Associated Standard: ISO 15883-3
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

ISO 13408-1:2023

Aseptic processing of health care products — Part 1: General requirements
Published: 2023, ISO
Associated Standard: ISO 13408-1
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 15883-5:23

Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (Adopted ISO 15883-5:2021, first edition, 2021-07)
Published: 2023, CSA Group
Associated Standard: ISO 15883-5
Language: English, French
Format: PDF
Amendments, Redlines, Supplementary Amendments, Redlines, Supplementary

ISO 11607-2:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
Published: 2023, ISO
Associated Standard: ISO 11607-2
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

ISO 11737-3:2023

Sterilization of health care products — Microbiological methods — Part 3: Bacterial endotoxin testing
Published: 2023, ISO
Associated Standard: ISO 11737-3
Language: English, French
Format: PDF
Amendments, Redlines, Supplementary Amendments, Redlines, Supplementary

ISO 11607-1:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
Published: 2023, ISO
Associated Standard: ISO 11607-1
Language: English, French
Format: PDF
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CSA ISO/TS 16775:23

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO Technical Specification 16775:2021, second edition, 2021-11)
Published: 2023, CSA Group
Associated Standard: ISO/TS 16775
Language: English
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 17664-1:23

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07)
Published: 2023, CSA Group
Associated Standard: ISO 17664-1
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

CSA ISO 17664-2:23

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02)
Published: 2023, CSA Group
Associated Standard: ISO 17664-2
Language: English, French
Format: PDF
Codes and Standards Codes and Standards

ISO 22441:2022

Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
Published: 2022, ISO
Associated Standard: ISO 22441
Language: English, French
Format: PDF
Amendments, Redlines, Supplementary Amendments, Redlines, Supplementary

CAN/CSA-Z11137-1-07 (R2021)/A2:22

Amendment 2:2022 to CAN/CSA-Z11137-1-07, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Adopted amendment 2:2018 to ISO 11137-1:2006)
Published: 2022, CSA Group
Associated Standard: Z11137-1/A2:22
Language: English, French
Format: PDF
Amendments, Redlines, Supplementary Amendments, Redlines, Supplementary

ISO 25424:2018/Amd 1:2022

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
Published: 2022, ISO
Associated Standard: ISO 25424
Language: English, French
Format: PDF