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BSI BS EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices
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BSI BS EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices

PUBLISH DATE 2013
PAGES 28
BSI BS EN 1041:2008+A1:2013
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).
SDO BSI: British Standards Institution
Document Number EN 1041
Publication Date Oct. 31, 2013
Language en - English
Page Count 28
Revision Level 1
Supercedes
Committee CH/210/3
Publish Date Document Id Type View
Aug. 31, 2008 BS EN 1041:2008 Revision
July 15, 1998 BS EN 1041:1998 Revision
Oct. 31, 2013 BS EN 1041:2008+A1:2013 Consolidated