UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - BS EN ISO 18153

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

active, Most Current
Buy Now
Organization: BSI
Publication Date: 19 August 2003
Status: active
Page Count: 20
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

BS EN ISO 18153
August 19, 2003
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
A description is not available for this item.

References

This document references:
EN 12287 - In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials
Published by CEN on June 1, 1999
A description is not available for this item.
This document references:
98/79/EC CORR - CORRIGENDUM to the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
Published by EU on October 27, 1998
A description is not available for this item.
This document references:
DS/EN ISO 17511 - In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials
Published by DS on September 26, 2003
This 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...
This document references:
ISO 17511 - In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
Published by ISO on April 1, 2020
This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for...
This document is referenced by:
BS EN ISO 15194 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
Published by BSI on May 31, 2009
A description is not available for this item.
This document is referenced by:
BS EN ISO 15195 - Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
Published by BSI on February 28, 2019
A description is not available for this item.
This document is referenced by:
BS EN ISO 15193 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
Published by BSI on May 31, 2009
A description is not available for this item.
This document is referenced by:
BS EN ISO 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) -Part 1: Terms, definitions and general requirements
Published by BSI on October 31, 2011
A description is not available for this item.
This document is referenced by:
BS EN ISO 18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
Published by BSI on November 30, 2011
A description is not available for this item.
View Less
View All

Related Products

Searching for related products...

Advertisement