Need help?

EN ISO 15194:2009 Standard

wave
Save  

  Keywords:

#standard #international #measurement #standards #calibrators

  Directive

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

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)

  Purpose

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. This International Standard also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities. This International Standard does not apply to reference materials that are parts of an  in vitro diagnostic measuring system, although it is possible that many elements are helpful.

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 18113-2:2011

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

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents ...

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...

EN ISO 11737-2:2020

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

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

EN ISO 11607-1:2020

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

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

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 61326-2-6:2006

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

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0