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EN 13641:2002 Standard

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  Keywords:

#materials #control #standard #applicable #containing

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

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

  Purpose

This European Standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.

  Publication

Friday 17th of November 2017

  Related Standards

EN 556-1:2001

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-1:2001/AC:2006

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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-2:2015

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Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN ISO 11137-1:2015

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

EN ISO 11137-2:2015

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

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 11737-2:2009

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

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

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