Medical devices. Application of risk management to medical devices Ingestion-build-47182 Some clauses of ISO 5167:2003

Some clauses of ISO 5167:2003 (parts 1 to 4) are not commented upon and the corresponding clause numbers are omitted from this Technical Report

Construction companies

Precision statement (Statement of accuracy)

including their elements of building hardware

7 fub × As1) according to BS EN 1993-1-8:2005 (Eurocode 3) and to obtain ductility predominantly by plastic elongation of the bolt for system HR according to EN 14399-3 or by plastic deformation of the engaged threads for system HV according to EN 14399-4

Medical devices. Application of risk management to medical devices Ingestion-build-47182 Some clauses of ISO 5167:2003BS 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