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SRPS EN ISO 11607-1:2011

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

May 31, 2011
95.99   Withdrawal of Standard   Dec 25, 2017

General information

95.99     Dec 25, 2017

ISS

Z076

European Norm

11.080.30  

English  

From plan 2011

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
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

WITHDRAWN
SRPS EN ISO 11607-1:2009

NOW

WITHDRAWN
SRPS EN ISO 11607-1:2011
95.99 Withdrawal of Standard
Dec 25, 2017

REVISED BY

WITHDRAWN
SRPS EN ISO 11607-1:2017

Related project

Adopted from EN ISO 11607-1:2009

Adopted from ISO 11607-1:2006 IDENTICAL