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SRPS EN ISO 11607-1:2020/A11:2022

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

Sep 30, 2022
Dec 30, 2022

General information

60.60     Sep 30, 2022

ISS

Z076

European Norm

11.080.30  

English   Serbian  

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Scope

This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Related directives

Directives related to this standard.

90/385/EEC

Active implantable medical devices

98/79/EC

In vitro diagnostic medical devices

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

93/42/EEC

Medical devices

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Life cycle

NOW

PUBLISHED
SRPS EN ISO 11607-1:2020/A11:2022
60.60 Standard published
Sep 30, 2022

Related project

Adopted from EN ISO 11607-1:2020/A11:2022 IDENTICAL