Need help?

EN ISO 11137-2:2015 Standard

wave
Save  

  Keywords:

#part #methods #kgy #sterility #achieve

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

  Purpose

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 11137-2:2013"

Anyway is still possible use the "EN ISO 11137-2:2013" until June 30th, 2016

  Related Standards

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 45502-2-3:2010

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

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

EN ISO 13408-4:2011

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

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

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 13408-7:2015

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

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 14971:2012

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

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

  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