&nbsp
International Customer Service
Phone +49 30 2601-2759
Fax +49 30 2601-1263

Standard [WITHDRAWN]

DIN EN ISO 23640:2013-09

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011); German version EN ISO 23640:2013

German title
In-vitro-Diagnostika - Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen (ISO 23640:2011); Deutsche Fassung EN ISO 23640:2013
Publication date
2013-09
Original language
German
Pages
15

Please select

from 63.90 EUR VAT included

from 59.72 EUR VAT excluded

Purchasing options

PDF download 1
  • 63.90 EUR

  • 80.00 EUR

Shipment (3-5 working days) 1
  • 77.40 EUR

  • 96.70 EUR

1

 Attention: Document withdrawn!

Online service subscriptions

This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services
Publication date
2013-09
Original language
German
Pages
15

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice 

All transactions are encrypted

Overview

This standard is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. It specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in: - the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained; - the establishment of stability of the IVD reagent in use after the first opening of the primary container. The new edition of the standard has been initiated by the required revision of Annex ZA.

Content
Amendments

Replaces DIN EN ISO 23640:2012-03 .

This document has been replaced by:: DIN EN ISO 23640:2015-12 .

Cooperation at DIN

Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...