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

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  Keywords:

#devices #medical #process #sterilization #control

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  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 17664:2004

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical dev...

EN ISO 11737-1:2006/AC:2009

Medical devices Directive (93/42/EEC)

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

EN ISO 13408-6:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 13408-5:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

EN ISO 13408-4:2011

Medical devices Directive (93/42/EEC)

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

EN ISO 13408-3:2011

Medical devices Directive (93/42/EEC)

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

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