BS EN 1041:2008+A1:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Information supplied by the manufacturer of medical devices
Hardcopy , PDF
10-06-2022
English
31-10-2013
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/210/3
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| DocumentType |
Standard
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| Pages |
28
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| PublisherName |
British Standards Institution
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
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).
| Standards | Relationship |
| EN 1041:2008+A1:2013 | Identical |
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