British Standards Institution

Source:: CEN
Committee:: CH/198 - Sterilization and Associated Equipment and Processes
Categories:: Sterilized packaging
Number of comments:: 0

Scope

This document specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefins, manufactured from nonwovens specified in EN 868-9 used for single-use sterile barrier systems and/or packaging systems for terminally sterilized medical devices.

Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

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Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

10/10/2025

3. Public Comments

Public Comments start date:

19/01/2026

Public Comments end date:

10/03/2026

4. Comment Resolution

Comment Resolution start date:

03/06/2027

5. Approval

6. Publication

Publication start date:

07/12/2027

Learn more about the standards development process

Standards Development

BS EN 868-10 Packaging for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

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