Need help?

EN ISO 17511:2003 Standard

wave
Save  

  Keywords:

#vitro #part #used #together #medical

  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 assigned to calibrators and control materials (ISO 17511:2003)

  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. 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 11137-2:2015

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 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)

EN ISO 13408-5:2011

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

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

EN ISO 13408-6:2011

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

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

EN ISO 13408-7:2015

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

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

EN ISO 13485:2016

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

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

  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