SS ISO 11607-1:+A1:2025

Packaging for terminally sterilised medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

OVERVIEW

This standard specifies requirements and test methods for materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices until the point of use.

It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.

COMMENTS

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PRODUCT DETAILS

Status Current
Edition +A1:2025
No. of Pages 77
ICS Classification 11.180.30 Aids for blind or partially sighted people
Committee Biomedical and Health Standards Committee
Available for Purchase Global
Adoption ISO 11607 : 2019+A1:2025 IDT