EN 1041:2008/FprA1

SLOVENSKI STANDARD
01-marec-2013
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Information supplied by the manufacturer of medical devices
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten
Informations fournies par le fabricant de dispositifs médicaux
Ta slovenski standard je istoveten z: EN 1041:2008/FprA1
ICS:
01.110 7HKQLþQDGRNXPHQWDFLMD]D Technical product
L]GHONH documentation
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 1041:2008
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
January 2013
ICS 01.110; 11.040.01; 11.120.01

English version
Information supplied by the manufacturer of medical devices
Informations fournies par le fabricant de dispositifs Bereitstellung von Informationen durch den Hersteller von
médicaux Medizinprodukten
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/CLC/TC 3.
This draft amendment A1, if approved, will modify the European Standard EN 1041:2008. If this draft becomes an amendment, CEN and
CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration.

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

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

CEN-CENELEC Management Centre:
Avenue Marnix 17, B-1000 Brussels
© 2013 CEN/CENELEC All rights of exploitation in any form and by any means reserved Ref. No. EN 1041:2008/FprA1:2013 E
worldwide for CEN national Members and for CENELEC
Members.
Contents Page
Foreword . 3
1 Modifications to Clause 2 . 4
2 Modification to 4.2 . 4
3 Modification to 5.1 . 4
4 Modifications to the Bibliography . 5

Foreword
This document (EN 1041:2008/FprA1:2013) has been prepared by Technical Committee CEN/CLC/TC 3
“Quality management and corresponding general aspects for medical devices”, the secretariat of which is held
by NEN.
This document is currently submitted to the Unique Acceptance Procedure.
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 Directives.
For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts of this
document.
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