Medical devices. Guidance on the application of ISO 14971What is this published document about? Experience shows that manufacturers have difficulty with the practical implementation of some clauses in the medical devices risk management standard BS EN ISO 14971. This published document is the UK implementation of an international Technical Report. It supplies guidance on tackling specific clauses in the standard. Who is this published document for? Medical device manufacturers Regulators Other users of BS

3 Recommended uses

and their fittings

Clause 2: Alloys EN AW-5049

ensuring the quality and consistency of the product

Video baseband requirements

monitor and control similar characteristics on different items

with tyre inflation pressures referenced in units of either kilopascals (kPa) or bar1)

6 Free angular movement or misalignment

BS EN 15476:2009 supersedes DD CEN/TS 15476:2006

inspection and marking for the type approval

Quality/health and safety industries

BS ISO 26362 is applicable to all types of access panels