EN ISO 11607-1:2017

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)

Publication date:   Nov 15, 2017

General information

99.60 Withdrawal effective   Jan 15, 2020

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

90/385/EEC

Active implantable medical devices

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

Replaces
EN ISO 11607-1:2009

Replaces
EN ISO 11607-1:2009/A1:2014

NOW

WITHDRAWN
EN ISO 11607-1:2017
99.60 Withdrawal effective
Jan 15, 2020

REVISED BY

PUBLISHED
EN ISO 11607-1:2020

Relations

Adopted from ISO 11607-1:2006/Amd 1:2014 IDENTICAL

Adopted from ISO 11607-1:2006 IDENTICAL