BS EN 1041:1998 - Information supplied by the manufacturer with medical devices – BSI British Standards

BS EN 1041:1998

Information supplied by the manufacturer with medical devices

Status : Revised, Superseded, Withdrawn   Published : July 1998 Replaced By : BS EN 1041:2008+A1:2013

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This European Standard specifies requirements for the information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the language to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.




Standard NumberBS EN 1041:1998
TitleInformation supplied by the manufacturer with medical devices
StatusRevised, Superseded, Withdrawn
Publication Date15 July 1998
Withdrawn Date01 August 2011
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Replaced ByBS EN 1041:2008+A1:2013
International RelationshipsEN 1041:1998
Draft Superseded By93/502178 DC
DescriptorsMedical equipment, Implants (surgical), Medical instruments, Technical documents, Instructions for use, Handbooks, Documents, Marking, Identification methods, Packaging, Sterile equipment, Definitions, Consumer-supplier relations, Symbols, Safety measures, Hazards
ICS01.110
11.040.01
11.120.01
Title in FrenchInformations fournies par le fabricant avec les dispositifs medicaux
Title in GermanBereitstellung von Informationen durch den Hersteller eines Medizinprodukts
CommitteeCH/210/3
ISBN0 580 29800 0
PublisherBSI
FormatA4
DeliveryNo
Pages18
File Size180 KB
Price£130.00


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