Need help?

EN ISO 11607-1:2020 Standard

wave
Save  

  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

EN 556-1:2001

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN ISO 13485:2016/AC:2018

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

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

EN ISO 13408-6:2011

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

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 13408-5:2011

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

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

EN ISO 13408-1:2015

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

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

EN ISO 11737-2:2009

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

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

  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