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 23640

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

active, Most Current
Buy Now
Organization: BSI
Publication Date: 30 June 2015
Status: active
Page Count: 16
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

BS EN ISO 23640
June 30, 2015
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
A description is not available for this item.
BS EN ISO 23640
March 31, 2013
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
A description is not available for this item.
BS EN ISO 23640
June 30, 2012
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
A description is not available for this item.

References

This document references:
EP25 - Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
Published by CLSI on April 1, 2023
This guideline provides information for establishing and verifying (confirming) shelf‑life and in‑use stability claims for quantitative in vitro diagnostic (IVD) medical laboratory reagents or...
This document references:
EN 13640 - Stability Testing of in Vitro Diagnostic Reagents
Published by CEN on March 1, 2002
A description is not available for this item.
This document references:
EN 13640 - Stability Testing of in Vitro Diagnostic Reagents
Published by CEN on March 1, 2002
A description is not available for this item.
This document references:
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 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:
BS EN ISO 14971 + A11 - Medical devices - Application of risk management to medical devices
Published by BSI on December 31, 2019
A description is not available for this item.
This document is referenced by:
BS EN ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by BSI on June 30, 2015
A description is not available for this item.
View Less
View All
Advertisement