Need help?

EN ISO 11607-1:2020/A1:2023 Standard

wave
Save  

  Keywords:

#covers #management #risk #can #eu

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 28th of January 2026

  Description:

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

  Purpose

ISO 11607-1 describes requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. EN ISO 11607-1:2020/A1:2023 modifies the European standard EN ISO 11607-1:2020. The main text of this standard can be found in the standard’s history. In this amendment you can find: — the relationship between EN ISO 11607-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/745, — the relationship between EN ISO 11607-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/746, — Annex F (normative) which covers risk management topics, — Annex G (informative) which covers risk management for medical device packaging and gives rationale for the requirements.

  Publication

Friday 8th of March 2024

  Amendment

This standard is an amendment for "EN ISO 11607-1:2020"

  Related Standards

EN ISO 20916:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO ...

EN ISO 11737-2:2020

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

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

EN ISO 18113-1:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and gener...

EN ISO 18113-2:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents ...

EN ISO 18113-3:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instrumen...

EN ISO 18113-4:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents ...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0