BS EN 1041:2008
BS EN 1041:2008 specifies the 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.
BS EN 1041:2008 is intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on the way that the requirements can be met. If a manufacturer follows BS EN 1041, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
BS EN 1041:2008 does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards.
When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.
Keywords: Medical 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
Product Code(s): 30123165,30123165
- This product references:ISO 3166-1:2006 - Codes for the representation of names of countries and their subdivisions - Part 1: Country codes
ISO 7000:1989 - Graphical symbols for use on equipment; index and synopsis
ISO 14971:2007 - Medical devices - Application of risk management to medical devices
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 15225:2000 - Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
This product referenced by:BS EN ISO 16061:2008 - Information supplied by the manufacturer of medical devices
BS 12/30244415 DC - Information supplied by the manufacturer of medical devices
BS 12/30261215 DC - Information supplied by the manufacturer of medical devices
This product replaces:BS EN 1041:1998 - Information supplied by the manufacturer with medical devices
BS EN 1041:2008
BS EN 1041:1998
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