Medical devices. Application of risk management to medical devices shop-only A new annex contains a

A new annex contains a competence standard for fire risk assessors

Manufacturer of heating appliances

in order to investigate whether a specific International Standard is really required and if it compensates the limitations of the Vickers hardness test currently used

BS EN 1282-2 is a European Standard which specifies requirements for paediatric tracheostomy tubes made of plastics materials and/or rubber having inside diameters from 2

It applies to treatment equipment where all prefabricated components are factory or site-assembled by one manufacturer and tested as a single unit

Medical devices. Application of risk management to medical devices shop-only A new annex contains aBS 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