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Biological evaluation

If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:

The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive.

Several new parts in the series have been developed which promote a new philosophy of biological evaluation (particularly parts 17,18 and 19). 

BSI’s International standards also give requirements for the preparation, conduct and performance of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices.

BS EN ISO 10993-1:2009
Biological evaluation of medical devices. Evaluation and testing

BS EN 455-3:2006
Medical gloves for single use. Requirements and testing for biological evaluation

BS EN ISO 7405:2008
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

View the rest of the BS EN ISO 10993 series of standards

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