National foreword

This British Standard is the official English language version of EN 13640:2002.

The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to:

aid enquirers to understand the text;
present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developments and promulgate them in the UK.

A list of organizations represented on this committee can be obtained on request to its secretary.

Cross-references

The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled "International Standards Correspondence Index", or by using the "Find" facility of the BSI Standards Electronic Catalogue.

A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 3 May 2002

This European Standard was approved by CEN on 27 December 2001.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This document EN 13640:2002 has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medical devices", the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at the latest by September 2002.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.

Annexes A and ZA are for information only.

This standard includes a Bibliography.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

1 Scope

This European Standard is applicable to the stability testing of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. It specifies general requirements for stability testing and gives specific requirements for real-time testing and accelerated testing when generating stability data in the

determination of IVD reagent shelf-life including transport stability;
determination of stability of the IVD reagent in use after the first opening of the primary container (e. g. on-board stability);
monitoring of stability of IVD reagents already placed on the market;
verification of stability afterverification of stability after IVD reagent modifications that may affect stability.

This standard does not apply to instruments, apparatus, equipment, systems, or specimen receptacles.

2 Terms and definitions

3 General requirements

3.1 Protocol

3.2 Final report

4 Procedures

4.1 General

4.2 Real-time stability testing

4.3 Accelerated stability testing

Bibliography

BS EN 13640:2002

Stability testing of in vitro diagnostic reagents

Published:

3 May 2002

Withdrawn:

30 Jun 2012