Medical devices. Application of risk management to medical devices Ingestion-build-47182 Contents of BS EN 12643:

Contents of BS EN 12643:

in community medical facilities and in dental institutions

including their elements of building hardware

Precision statement (Statement of accuracy)

BS 8520-2 does not apply to local exhaust ventilation

Medical devices. Application of risk management to medical devices Ingestion-build-47182 Contents of BS EN 12643:BS EN ISO 14971: 2012 Medical devices. Application of risk management to medical devices In 2011 the European Commission raised a concern around the legal text supporting presumption of conformity to the Medical Device Directives (Annexes ZA, ZB, ZC) in EN ISO 14971: 2009. The outcome was that CEN decided to publish a new edition of the standard (EN ISO 14971: 2012). This standard has a revised Foreword and Annexes ZA, ZB and ZC, but the core text