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ISO 11607-1:2006

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

Publication date:   Apr 7, 2006

95.99 Withdrawal of Standard   Jan 31, 2019

General information

95.99 Withdrawal of Standard   Jan 31, 2019

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.30   Sterilized packaging

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11607:2003

NOW

WITHDRAWN
ISO 11607-1:2006
95.99 Withdrawal of Standard
Jan 31, 2019

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 11607-1:2006/Amd 1:2014

REVISED BY

PUBLISHED
ISO 11607-1:2019