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ISO/FDIS 18969Under developmentClinical evaluation of medical devices - Principles and process for planning and performing clinical evaluationISO 13485:2003WithdrawnMedical devices — Quality management systems — Requirements for regulatory purposesISO 13485:1996WithdrawnQuality systems — Medical devices — Particular requirements for the application of ISO 9001ISO 13488:1996WithdrawnQuality systems — Medical devices — Particular requirements for the application of ISO 9002ISO/TR 14969:2004WithdrawnMedical devices — Quality management systems — Guidance on the application of ISO 13485: 2003ISO 14969:1999WithdrawnQuality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488ISO 14971:2007WithdrawnMedical devices — Application of risk management to medical devicesISO 14971:2000WithdrawnMedical devices — Application of risk management to medical devicesISO 14971-1:1998WithdrawnMedical devices — Risk management — Part 1: Application of risk analysisISO 15223-1:2016WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsISO 15223-1:2012WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsISO 15223-1:2007WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirementsISO 15223:2000WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be suppliedISO/TR 15223:1998WithdrawnMedical devices — Symbols to be used with medical device labels, labelling and information to be suppliedISO 15225:2016WithdrawnMedical devices — Quality management — Medical device nomenclature data structureISO 15225:2010WithdrawnMedical devices — Quality management — Medical device nomenclature data structureISO 15225:2000WithdrawnNomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchangeISO 15378:2015WithdrawnPrimary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)ISO 15378:2011WithdrawnPrimary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)ISO 15378:2006WithdrawnPrimary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)ISO 16142-2:2017WithdrawnMedical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standardsISO 16142-1:2016WithdrawnMedical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standardsISO/TR 16142:2006WithdrawnMedical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devicesISO/TR 16142:1999WithdrawnMedical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devicesISO/PAS 18761:2013WithdrawnUse and handling of medical devices covered by the scope of ISO/TC 84 — Risk assessment on mucocutaneous blood exposure