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

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BS EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices

Status : Current, Work in hand   Published : August 2008

Format
PDF

Format
HARDCOPY



What is this standard about?

It exists to help medical device manufacturers comply with the information requirements of the European medical device directives.

Who is this standard for?

Manufacturers of medical devices

Why should you use this standard?

It specifies requirements for information to be supplied by manufacturers of 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.

The standard is also intended to complement the specific requirements of the cited EU Directives 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.

What’s changed since the last update?

This first amendment to BS EN 1041:2008 implements CEN/CENCELC amendment A1:2013. The principal changes are the addition of clauses on the provision of information on the safe and effective use of the device (5.1.1) and on the format and location of the manufacturer’s name and address as required by the medical devices directives (5.1.2).




Standard NumberBS EN 1041:2008+A1:2013
TitleInformation supplied by the manufacturer of medical devices
StatusCurrent, Work in hand
Publication Date29 August 2008
Cross ReferencesEN ISO 3166-1, ISO 3166-1:2006, ISO 639-1, ISO 1000, ISO 8601, CEN/TR 15133, EN 375, EN 376, EN 556-1, EN 556-2, EN 591, EN 592, EN ISO 780, EN ISO 13485, ISO 13485:2003, ISO 7000, 98/79/EC, 89/617/EEC, 2004/108/EC, 93/465/EEC, 89/618/Euratom, 80/181/EEC, 90/385/EEC, 93/42/EEC, EN ISO 14971, ISO 14971:2007, EN ISO 15225, ISO 15225:2000, EN ISO 17664, ISO 17664:2004, EN 980, EN ISO 15223-1
ReplacesBS EN 1041:1998
International RelationshipsEN 1041:2008+A1:2013
Amended ByAmendment, October 2013
Draft Superseded By13/30272487 DC
DescriptorsInstructions for use, Consumer-supplier relations, Technical documents, Symbols, Identification methods, Handbooks, Marking, Definitions, Implants (surgical), Medical equipment, Hazards, Packaging, Safety measures, Sterile equipment, Documents, Medical instruments
ICS01.110
11.040.01
11.120.01
Title in FrenchInformations fournies par le fabricant de dispositifs médicaux
Title in GermanBereitstellung von Informationen durch den Hersteller von Medizinprodukten
CommitteeCH/210/3
ISBN978 0 580 80873 9
PublisherBSI
FormatA4
DeliveryYes
Pages28
File Size762 KB
Price£176.00


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