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Codes & Standards

CSA ISO 11607-1:21

Packaging for terminally sterilized medical devices — 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 — 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/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)

  • English
  • Published in 2023
  • Published by CSA Group
  • Subscription Available
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ISO 11607-1:2019

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • English, French
  • Published in 2019
  • Published by ISO
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ISO 11607-2:2019

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
  • English, French
  • Published in 2019
  • Published by ISO
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ISO 21881:2019

Sterile packaged ready for filling glass cartridges
  • English
  • Published in 2019
  • Published by ISO
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ISO 21882:2019

Sterile packaged ready for filling glass vials
  • English
  • Published in 2019
  • Published by ISO
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ISO/TS 16775:2021

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
  • English, French
  • Published in 2021
  • Published by ISO