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Codes & Standards

CAN/CSA-Z11137-1-07 (R2021)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11137-1:2006, first edition, 2006-04-15)

  • English, French
  • Published in 2007
  • Reaffirmed in 2021
  • Published by CSA Group
  • Subscription Available
Codes & Standards

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)

  • English, French
  • Published in 2022
  • Published by CSA Group
Codes & Standards - Subscribe

CAN/CSA-Z314.7-03 (R2013)

Steam Sterilizers for Health Care Facilities
  • English, French
  • Published in 2003
  • Reaffirmed in 2013
  • Published by CSA Group
Codes & Standards

CSA ISO 11139:19

Sterilization of health care products β€” Vocabulary of terms used in sterilization and related equipment and process standards (Adopted ISO 11139:2018, first edition, 202018-08)

  • English, French
  • Published in 2019
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 11607-1:21

Packaging for terminally sterilized medical devices β€” Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02)

  • English, French
  • Published in 2021
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 11607-2:21

Packaging for terminally sterilized medical devices β€” Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02)

  • English, French
  • Published in 2021
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 11737-1:19

Sterilization of health care products β€” Microbiological methods β€” Part 1: Determination of a population of microorganisms on products (Adopted ISO 11737-1:2018, third edition, 2018-01)

  • English, French
  • Published in 2019
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 11737-2:21

Sterilization of health care products β€” Microbiological methods β€” Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (Adopted ISO 11737-2:2019, third edition, 2019-12)

  • English, French
  • Published in 2021
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 15883-4:19

Washer-disinfectors β€” Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (Adopted ISO 15883-4:2018, second edition, 2018-11)

  • English, French
  • Published in 2019
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 15883-5:23

Washer-disinfectors β€” Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (Adopted ISO 15883-5:2021, first edition, 2021-07)

  • English, French
  • Published in 2023
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 17664-1:23

Processing of health care products β€” Information to be provided by the medical device manufacturer for the processing of medical devices β€” Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07)

  • English, French
  • Published in 2023
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 17664-2:23

Processing of health care products β€” Information to be provided by the medical device manufacturer for the processing of medical devices β€” Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02)

  • English, French
  • Published in 2023
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO 20857:19

Sterilization of health care products β€” Dry heat β€” Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 20857:2010, first edition, 2010-08-15

  • English, French
  • Published in 2019
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO/TS 11137-4:21

Sterilization of health care products β€” Radiation β€” Part 4: Guidance on process control (Adopted ISO technical specification 11137-4:2020, first edition, 2020-06)

  • English
  • Published in 2021
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA ISO/TS 16775:23

Packaging for terminally sterilized medical devices β€” Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO Technical Specification 16775:2021, second edition, 2021-11)

  • English
  • Published in 2023
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA Z11138-7:21

Sterilization of health care products β€” Biological indicators β€” Part 7: Guidance for the selection, use and interpretation of results (Adopted ISO 11138-7:2019, with Canadian deviations)

  • English, French
  • Published in 2021
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA Z15882:09 (R2019)

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01)

  • English, French
  • Published in 2009
  • Reaffirmed in 2019
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA Z15883-1:09 (R2019)

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (Adopted ISO 15883-1:2006, first edition, 2006-04-15, with Canadian deviations)

  • English, French
  • Published in 2009
  • Reaffirmed in 2019
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA Z15883-2:09 (R2019)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (Adopted ISO 15883-2:2006, first edition, 2006-04-15)

  • English, French
  • Published in 2009
  • Reaffirmed in 2019
  • Published by CSA Group
  • Subscription Available
Codes & Standards

CSA Z15883-3:09 (R2019)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (Adopted ISO 15883-3:2006, first edition, 2006-04-15, with Canadian deviations)

  • English, French
  • Published in 2009
  • Reaffirmed in 2019
  • Published by CSA Group
  • Subscription Available