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ISO - International Organization for Standardization

QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES

Standard and/or Project Current Stage ICS ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements 90.93 11.040.25 ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings 90.20 11.040.25 ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes 90.93 11.040.01 03.120.10 ISO/TR 14969:2004 Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003 90.93 03.120.10 11.040.01 ISO 14971:2007 Medical devices -- Application of risk management to medical devices 60.60 11.040.01 ISO 15223:2000 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied 90.92 11.040.01 01.080.99 ISO 15223:2000/Amd 1:2002 60.60 11.040.01 01.080.99 ISO 15223:2000/Amd 2:2004 60.60 01.080.99 11.040.01 ISO/CD 15223-1 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements 30.99 11.040.01 01.080.20 ISO 15223-1:2007 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements 90.92 11.040.01 01.080.20 ISO 15223-1:2007/Amd 1:2008 60.60 01.080.20 11.040.01 ISO/DIS 15223-2 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 2: Symbol development, selection and validation 40.60 11.040.01 01.080.20 ISO 15225:2000 Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange 90.92 11.040.01 35.240.80 ISO/DIS 15225 Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange 40.60 35.240.80 11.040.01 ISO 15225:2000/Amd 1:2004 60.60 11.040.01 35.240.80 ISO/TR 16142:2006 Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices 60.60 11.040.01 ISO/TS 19218:2005 Medical devices -- Coding structure for adverse event type and cause 90.92 11.040.01 03.120.10 IEC 62304:2006 Medical device software -- Software life cycle processes 60.60 35.240.80 11.040.01 IEC 62366:2007 Medical devices -- Application of usability engineering to medical devices 60.60 11.040.01 ISO/CD 80369-1 Small bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements 30.20 11.040.10 11.040.20