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Din en 01041 1998 (En)

This document outlines standards for information that medical device manufacturers must provide with their products. It describes the purpose and scope of the standards, provides definitions, and outlines requirements for the content and presentation of information for users and those involved in the use of medical devices.

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0% found this document useful (0 votes)
149 views26 pages

Din en 01041 1998 (En)

This document outlines standards for information that medical device manufacturers must provide with their products. It describes the purpose and scope of the standards, provides definitions, and outlines requirements for the content and presentation of information for users and those involved in the use of medical devices.

Uploaded by

saurabhnis1995
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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D EUTSCHE NORM April 1998

Medical devices {
Information supplied by the manufacturer
English version of DIN EN 1041 EN 1041
ICS 01.110; 11.040.01; 11.120.01

Descriptors: Medical devices, information, manufacturers.

Bereitstellung von Informationen durch den Hersteller eines Medizinprodukts

European Standard EN 1041 : 1998 has the status of a DIN Standard.

A comma is used as the decimal marker.

National foreword
This standard has been prepared by CEN/TC 257.
The responsible German body involved in its preparation was the Normenausschuß Medizin (Medical Stand-
ards Committee).
DIN 1313 and DIN EN 28601 are the standards corresponding to International Standards ISO 31 and
ISO 8601, respectively, referred to in clause 2 of the EN.

National Annex NA
Standards referred to
(and not included in Normative references)
DIN 1313 Physical quantities and equations – Concepts and nomenclature
DIN EN 28601 Data elements and interchange formats – Information interchange – Representation of dates
and times (ISO 8601 : 1988)

Continued overleaf.
EN comprises 24 pages.

© No part of this standard may be reproduced without the prior permission of Ref. No. DIN EN 1041 : 1998-04
DIN Deutsches Institut für Normung e. V., Berlin. English price group 12 Sales No. 1112
Beuth Verlag GmbH, D-10772 Berlin, has the exclusive right of sale for German Standards (DIN-Normen).
09.98
EN 1041

February 1998

ICS 01.110; 11.040.01; 11.120.01


Descriptors: Medical devices, information, manufacturers.

English version

Information supplied by the manufacturer


with medical devices

Informations fournies par le fabricant Bereitsstellung von Informationen


avec les dispositifs médicaux durch den Hersteller eines Medizin-
produkts

This European Standard was approved by CEN on 1998-01-18.


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 stand-
ards may be obtained on application to the Central Secretariat or to any CEN
member.
The European Standards exist 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 Central Secretariat has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, the Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland,
and the United Kingdom.

È
|ÉË
European Committee for Standardization
Comité Européen de Normalisation
Europäisches Komitee für Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

© 1998. CEN – All rights of exploitation in any form and by any means Ref. No. EN 1041 : 1998 E
reserved worldwide for CEN national members.
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