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EN ISO 11135:2014/A1:2019 Standard

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  Keywords:

#amendment #development #devices #medical #process

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 16th of July 2021

  Description:

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

  Purpose

Amendment for EN ISO 11135:2014

  Publication

Friday 16th of July 2021

  Amendment

This standard is an amendment for "EN ISO 11135:2014"

  Related Standards

EN ISO 8359:2009/A1:2012

Medical devices Directive (93/42/EEC)

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

EN 20594-1:1993

Medical devices Directive (93/42/EEC)

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (...

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 17665-1:2006

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

EN ISO 18777:2009

Medical devices Directive (93/42/EEC)

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

EN ISO 18778:2009

Medical devices Directive (93/42/EEC)

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

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