ISO-11607-1 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems

ISO-11607-1 - 1ST EDITION - CURRENT -- See the following: ISO-11607-1-AM1


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 1ST EDITION - April 15, 2006
 FOR 1ST EDITION AMENDMENT 1 - July 15, 2014

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 11607-1:2006

Revision Level

1ST EDITION

Status

Current

Publication Date

April 15, 2006

Committee Number

ISO/TC 198