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EN ISO 11607-1:2020 Standard

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  Keywords:

#standard #healthcare #device #can #system

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  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 and sterile barrier systems, and packaging systems. This standard can be used by anyone in the healthcare industry or healthcare facilities. The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device components and the packaging system should be combined to create a sterile medical device that performs efficiently, safely and effectively in the hands of the user. This text also includes an amendment A1 and A11. The main text and the amendment can be found separately from the standard’s history. The international standard has been approved in Europe as EN ISO 11607-1:2020 without any changes and it supersedes EN ISO 11607-1:2017.

  Publication

Wednesday 14th of April 2021

  Related Standards

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EN ISO 11737-1:2006/AC:2009

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EN ISO 14155:2020

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EN ISO 11607-2:2020

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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 11135-1:2007

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a...

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