BS-EN-1041 Information supplied by the manufacturer of medical devices

BS-EN-1041 - 2008/A1 EDITION - CURRENT
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BS EN 1041 gives practical requirements for the information that has to be supplied by a manufacturer of medical equipment. The medical instruments covered are regulated by the Council Directive 90/385/EEC and relate to active surgical implants. BS EN 1041 sets out clear guidelines on how the Directive’s requirements can be met. By complying with this standard, manufacturers can prove that the information they deliver – such as technical documents, instructions for use and handbooks – conforms to the Directive’s essential requirements.

How does it work?

BS EN 1041 looks at the common terms used for medical implants, as well as the batch code, lot number, batch number and lot code. The standard then sets out the requirements that should be met when manufacturers provide more information. This includes applicability, accessibility, legibility and availability. It also gives guidance on alternative labelling for medical instruments and their instructions of use.

Who should buy it?

    Manufacturers of medical equipment
    Suppliers of components for medical implants
    Technical writers
    Health and safety officers
    Inspectors
    Suppliers of surgical implants


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

To find similar documents by classification:

01.110 (Technical product documentation Including rules for preparation of user guides, manuals, product specifications, etc.)

11.040.01 (Medical equipment in general)

11.120.01 (Pharmaceutics in general)

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Price:

$213.20




Document Number

BS EN 1041:2008+A1:2013

Revision Level

2008/A1 EDITION

Status

Current

Publication Date

Aug. 29, 2008

Replaces

BS EN 1041:1998

Page Count

28

ISBN

9780580808739

International Equivalent

EN 1041:2008

Committee Number

CH/210/3