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  • BSI
    BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    Edition: 2013
    $435.35
    / user per year

Description of BS EN 1041:2008+A1:2013 2013

This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).

Standard NumberBS EN 1041:2008+A1:2013
TitleInformation supplied by the manufacturer of medical devices
StatusWithdrawn
Publication Date2013-10-31
Withdrawn Date2021-05-11
ReplacesBS EN 1041:1998
Replaced ByBS EN ISO 20417:2021
Identical National Standard OfEN 1041:2008+A1:2013
AmendsBS EN 1041:2008
DescriptorsDocuments, Sterile equipment, Safety measures, Packaging, Hazards, Medical equipment, Implants (surgical), Definitions, Marking, Handbooks, Identification methods, Symbols, Technical documents, Consumer-supplier relations, Instructions for use, Medical instruments
ICS11.040.01 Medical equipment in general, 01.110 Technical product documentation, 11.120.01 Pharmaceutics in general
CommitteeCH/210/3
ISBN978 0 580 80873 9
PublisherBSI
Pages28

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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