NF S92-032:2014
In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

Standard No.

NF S92-032:2014

Release Date

2014

Published By

Association Francaise de Normalisation

Status

Be replaced 2015-12

Replace By

NF S92-032*NF EN ISO 23640:2015

Latest

NF S92-032*NF EN ISO 23640:2015

Replace

NF S92-032:2012

Scope

This International Standard applies to the evaluation of the stability of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, designated hereinafter “DIV reagents”. It can also be applied to devices for collecting a sample which contain substances used to preserve samples or to initiate reactions for subsequent processing of the sample in the collection device.

NF S92-032:2014 Referenced Document

• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update

NF S92-032:2014 history

• 2015 NF S92-032*NF EN ISO 23640:2015 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
• 2014 NF S92-032:2014 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
• 0000 NF S92-032:2012
• 2002 NF S92-032:2002 Stability testing of in vitro diagnostic reagents.