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EN ISO 11607-2:2020 Standard

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  Keywords:

#eu #can #relationship #regulation #performance

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

  Purpose

ISO 11607-2 sets out requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. EN ISO 11607-2:2020/A1:2023 modifies the European standard EN ISO 11607-2:2020. The main text can be found in the standard’s history. In this amendment you can find the following: — the relationship between EN ISO 11607-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/745, — the relationship between EN ISO 11607-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/746, — Annex B (normative) which covers risk management topics.

  Publication

Thursday 15th of April 2021

  Related Standards

EN ISO 18113-1:2011

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EN 12322:1999

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In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN ISO 11607-1:2020

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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN ISO 17511:2003

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assign...

EN ISO 11737-2:2020

In vitro diagnostic medical devices Directive (98/79/EC)

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

EN ISO 13485:2016

In vitro diagnostic medical devices Directive (98/79/EC)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

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