Summary of Changes from ISO 8871-5:2016 to ISO 8871-5:2025

Summary of Changes from ISO 8871-5:2016 to ISO 8871-5:2025

What manufacturers need to know about the 2025 revision

ISO 8871-5:2025 outlines functional testing for elastomeric components used in parenteral drug delivery. The updated standard replaces the 2016 version and is referenced in USP <382>, which becomes official in December 2025.

Notable Changes

  • Clarified definitions and updated terminology
  • Aligned particle testing criteria with ISO 11608-3 and USP <788>
  • Broader options for dye ingress testing beyond Methylene Blue
  • Continued acceptance of probabilistic integrity tests where appropriate
These revisions support harmonization with other device and packaging standards while maintaining flexibility in test methods.

Smithers Testing Support

Smithers provides elastomeric closure testing in compliance with ISO 8871-5:2025 and USP <382>. Our laboratories offer validated methods, regulatory insight, and objective data to support your product development and submissions.
Smithers ISO-8871-5_2025 Key Updates

Download the article on ISO 8871:

Smithers ISO-8871-5_2025 Key Updates

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