BRITISH STANDARD BS EN
13532:2002
General requirements
for in vitro diagnostic
medical devices for
self-testing
The European Standard EN 13532:2002 has the status of a
British Standard
ICS 11.100
NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
BS EN 13532:2002
National foreword
This British Standard is the official English language version of
EN 13532:2002.
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 Summary of pages
Environment Sector Policy and This document comprises a front cover, an inside front cover, the EN title page,
Strategy Committee, was pages 2 to 8, an inside back cover and a back cover.
published under the authority
of the Standards Policy and The BSI copyright date displayed in this document indicates when the
Strategy Committee on document was last issued.
8 May 2002
Amendments issued since publication
Amd. No. Date Comments
© BSI 8 May 2002
ISBN 0 580 39682 7
EUROPEAN STANDARD EN 13532
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2002
ICS 11.100
English version
General requirements for in vitro diagnostic medical devices for
self-testing
Exigences générales relatives aux dispositifs médicaux de Allgemeine Anforderungen an In-vitro-Diagnostika zur
diagnostic in vitro destinés à des auto-diagnostics Eigenanwendung
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.
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© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13532:2002 E
worldwide for CEN national Members.
