BSI BS EN 1041 Information supplied by the manufacturer of medical devices
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BSI BS EN 1041 Document Information:
Title
Information supplied by the manufacturer of medical devices
British Standards Institution
Publication Date:
Aug 31, 2008
Scope:
This 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.
Keywords:
- Medical equipment
- Implants (surgical)
- Medical instruments
- Technical documents
- Instructions for use
- Handbooks
- Documents
- Marking
- Identification methods
- Packaging
- Sterile equipment
- Definitions
- Terminology
- Consumer-supplier relations
- Symbols
- Safety measures
- Hazards
About IHS
IHS (NYSE: IHS) is a leading global provider of critical technical information, decision-support tools and related services in a number of industries including aerospace and defense, automotive, construction, electronics, and energy. IHS serves customers ranging from large governments and multinational corporations to smaller companies and technical professionals in more than 100 countries. IHS been in business for more than 45 years and employ more than 2,300 people around the world.
