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British Standards Institute (BSI) publishes guidance on device standards:

This article was originally published in Clinica

Executive Summary

Guidance on the application of EN 29001/2 and EN 46001/2 for the active medical device industry, including active implantables, has been published by the British Standards Institute. Copies, at £45 (£22.75 to BSI members), are available from BSI Customer Services. Tel: +44 (181) 996 7000. Fax: +44 (181) 996 7001.

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