EN ISO 23640:2011
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]

Standard No.

EN ISO 23640:2011

Release Date

2011

Published By

European Committee for Standardization (CEN)

Status

Be replaced 2013-02

Replace By

EN ISO 23640:2013

Latest

EN ISO 23640:2015

Scope

This International Standard is applicable to the stability evaluation of in vitro diagnostic medical devices, includingreagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents.ThisInternational Standard can also be applied to specimen collection devices that contain substances u

EN ISO 23640:2011 history

• 2015 EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)
• 2013 EN ISO 23640:2013 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
• 2011 EN ISO 23640:2011 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents [Superseded: CEN EN 13640]