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EN ISO 11135:2014 Standard

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  Keywords:

#amendment #development #devices #medical #process

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Monday 19th 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

Monday 19th of July 2021

  Related Standards

EN 14254:2004

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

EN ISO 18113-1:2011

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and genera...

EN 14136:2004

In vitro diagnostic medical devices Directive (98/79/EC)

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

EN ISO 11607-2:2020

In vitro diagnostic medical devices Directive (98/79/EC)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 14937:2009

In vitro diagnostic medical devices Directive (98/79/EC)

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

EN ISO 14971:2012

In vitro diagnostic medical devices Directive (98/79/EC)

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

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