What is BS EN 1041:2008?
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
- Suppliers of surgical implants
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