Need help?

EN ISO 11138-3:2009 Standard

wave
Save  

  Keywords:

#biological #indicators #test #sterilization #processes

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

  Purpose

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 11138-3:2006"

Anyway is still possible use the "EN ISO 11138-3:2006" until March 21st, 2010

  Related Standards

EN ISO 10993-17:2009

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

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

EN ISO 13408-3:2011

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

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

EN ISO 11138-2:2009

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

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

EN ISO 11140-1:2009

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

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

EN ISO 11737-1:2006

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

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

EN ISO 11737-1:2006/AC:2009

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

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

  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