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EN ISO 11137-1:2015/A2:2019 Standard

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  Keywords:

#devices #medical #process #sterilization #control

  Directive

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

  Last Official Journal reference

Wednesday 9th of October 2024

  Description:

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

  Purpose

Amendment for EN ISO 11137-1:2015

  Publication

Tuesday 20th of July 2021

  Amendment

This standard is an amendment for "EN ISO 11137-1:2015"

  Related Standards

EN ISO 14971:2019/A11:2021

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Medical devices - Application of risk management to medical devices (ISO 14971:2019)

EN ISO 15223-1:2021

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Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223...

EN ISO 14971:2019

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

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

EN ISO 13485:2016/AC:2018

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

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

EN ISO 13485:2016/A11:2021

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

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

EN ISO 13485:2016

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

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

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