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SRPS 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)

Dec 25, 2017
95.99   Withdrawal of Standard   Jun 22, 2020

General information

95.99     Jun 22, 2020

ISS

Z076

European Norm

11.080.30  

English  

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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

93/42/EEC

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

NOW

WITHDRAWN
SRPS EN ISO 11607-1:2017
95.99 Withdrawal of Standard
Jun 22, 2020

REVISED BY

PUBLISHED
SRPS EN ISO 11607-1:2020

Related project

Adopted from EN ISO 11607-1:2017

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

Adopted from ISO 11607-1:2006 IDENTICAL