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)

Publication date:   Oct 17, 2022

General information

60.60 Standard published   Jun 15, 2022

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

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 legislation

Legislation 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

PREVIOUSLY

PUBLISHED
EN ISO 11607-1:2020

NOW

PUBLISHED
EN ISO 11607-1:2020/A11:2022
60.60 Standard published
Jun 15, 2022