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EN 1422:1997+A1:2009 Standard

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  Keywords:

#sterilizers #medical #purposes #ethylene #oxide

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 1422:1997"

  Related Standards

EN ISO 18777:2009

Medical devices Directive (93/42/EEC)

Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)

EN ISO 10993-16:2010

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-...

EN ISO 11140-3:2009

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type...

EN ISO 11138-2:2009

Medical devices Directive (93/42/EEC)

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

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 11135-1:2007

Medical devices Directive (93/42/EEC)

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

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