ISO-11607-1 › Historical Revision Information
Amendment 1: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management

ISO-11607-1 - FOR 2ND EDITION AMENDMENT 1 SEE - CURRENT -- See the following: ISO-11607-1-AM1
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ISO 11607-1:2006 specifies the 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.

ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.

ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

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11.080.30 (Sterilized packaging)

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Document Number

ISO-11607-1

Revision Level

FOR 2ND EDITION AMENDMENT 1 SEE

Status

Current

Publication Date

Sept. 1, 2023

Committee Number

ISO/TC 198