Need help?

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

wave
Save  

  Keywords:

#devices #medical #process #sterilization #control

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  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

Wednesday 25th of March 2020

  Amendment

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

  Related Standards

EN ISO 17664:2017

Medical devices Directive (93/42/EEC)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical d...

EN ISO 11137-1:2015

Medical devices Directive (93/42/EEC)

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

EN ISO 13408-2:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

EN ISO 13408-1:2015

Medical devices Directive (93/42/EEC)

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

EN 13060:2014

Medical devices Directive (93/42/EEC)

Small steam sterilizers

EN ISO 11990-1:2014

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 11137-1:2015/A2:2019 STANDARD

  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