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RS ISO 11607-1: 2019/Amd 1: 2023
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
Abstract

This document 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.
It does not cover all requirements for sterile barrier systems and packaging systems for medical
devices that are manufactured aseptically. Additional requirements can be necessary for drug/device
combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device
during transportation of the item to the site of reprocessing or disposal.

General Information

CodeClassificationThemePagesPublisherAvailability
RS ISO 11607-1: 2019/Amd 1: 2023ADOPTED ISO STANDARDSHealth care technology75Second Edition
Apr 2025		Available
Price: RWF 25,500


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