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

ISO-11607-1 - FOR 1ST EDITION AMENDMENT 1 SEE - SUPERSEDED -- See the following: ISO-11607-1-AM1
Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:


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.

ORDER

To find similar documents by classification:

11.080.30 (Sterilized packaging)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ISO-11607-1

Revision Level

FOR 1ST EDITION AMENDMENT 1 SEE

Status

Superseded

Publication Date

July 15, 2014

Committee Number

ISO/TC 198