ISO 11607-1 Amendment 1:2023: Packaging Risk Management

When specifying packaging for terminally sterilised medical devices, identify the full document designation. A base standard, a separate amendment and a consolidated national publication are different purchasing and reference options.

What the amendment addresses

ISO 11607-1:2019/Amd 1:2023 adds risk-management application to the Part 1 requirements for materials, sterile barrier systems and packaging systems. ISO records its publication in September 2023.

A national adoption can have a different publication date. The EVS record for EN ISO 11607-1:2020/A1:2023 identifies an amendment publication. It should not be described as a new standalone edition containing the entire base standard.

Check what your copy contains

  • Confirm the base standard and all applicable amendments.
  • Check whether the supplied document is amendment-only or consolidated.
  • Distinguish European additions, such as an A11 amendment, from the international Amd 1.
  • Record the publication actually used in the assessment and document-control system.

A team updating its procedures should compare the changes with its existing packaging risk-management and validation records. Buying an amendment without checking the base document can leave the working reference incomplete.

Connect the change to evidence

Identify affected processes, responsibilities and records; then review whether the existing assessment addresses the amended requirements. Packaging evidence should remain traceable to the relevant device, packaging configuration and process.

This publication does not, by itself, establish sterility or overall regulatory conformity. Check the applicable product requirements, related validation work and the relevant regulatory references separately.

Reviewed 26 September 2026.

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