60.60 Standard published Jan 15, 2020
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.30 Sterilized packaging
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.
Legislation related to this standard
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
Harmonized/SupportingRegulation (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
Harmonized/Supporting
WITHDRAWN
EN ISO 11607-1:2017
PUBLISHED
EN ISO 11607-1:2020
60.60
Standard published
Jan 15, 2020
PUBLISHED
EN ISO 11607-1:2020/A1:2023
PUBLISHED
EN ISO 11607-1:2020/A11:2022