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

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  Keywords:

#devices #medical #process #sterilization #control

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  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 62366:2008

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

Medical devices - Application of usability engineering to medical devicesIEC 62366:2007

EN ISO 15193:2009

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

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and pre...

EN 13641:2002

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

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

EN 13975:2003

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

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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 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

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