Need help?

EN ISO 11607-1:2020 Standard

wave
Save  

  Keywords:

#standard #healthcare #device #can #system

This standard can be totally or partially supervised by:
  •   EN ISO 11607-1:2020/A1:2023
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Wednesday 1st of April 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 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

    Friday 8th of March 2024

      Related Standards

    EN 14683:2025

    Medical devices Regulation ((EU) 2017/745)

    Medical face masks - Requirements and test methods

    EN ISO 11135:2014/A1:2019

    Medical devices Regulation ((EU) 2017/745)

    Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

    EN ISO 17665:2024

    Medical devices Regulation ((EU) 2017/745)

    Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterili...

    EN ISO 14630:2024

    Medical devices Regulation ((EU) 2017/745)

    Non-active surgical implants - General requirements (ISO 14630:2024)

    EN ISO 14155:2020/A11:2024

    Medical devices Regulation ((EU) 2017/745)

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

    EN ISO 14155:2020

    Medical devices Regulation ((EU) 2017/745)

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

      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