Need help?

EN ISO 18153:2003 Standard

wave
Save  

  Keywords:

#vitro #manufacturers #part #used #together

  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 biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

  Purpose

This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices

  Publication

Friday 17th of November 2017

  Related Standards

EN ISO 11137-1:2015/A2:2019

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

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

EN ISO 15223-1:2016

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

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

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

EN 14820:2004

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

Single-use containers for human venous blood specimen collection

  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