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ISO/TC 210  - Quality management and corresponding general aspects for medical devices

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Standards and projects under the direct responsibility of ISO/TC 210 Secretariat and its SCs

Standard and/or projectStageICSTC
ISO/IEC Guide 63:2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices
60.60 11.020
01.120
ISO/TC 210
ISO 594-1:1986
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements
90.60 11.040.25ISO/TC 210
ISO 594-2:1998
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings
90.20 11.040.25ISO/TC 210
ISO 13485:2003
Medical devices -- Quality management systems -- Requirements for regulatory purposes
90.92 03.120.10
11.040.01
ISO/TC 210
ISO 13485:2003/Cor 1:2009
60.60 11.040.01
03.120.10
ISO/TC 210
ISO/TR 14969:2004
Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
90.93 11.040.01
03.120.10
ISO/TC 210
ISO 14971:2007
Medical devices -- Application of risk management to medical devices
90.93 11.040.01ISO/TC 210
ISO 15223-1:2012
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
60.60 01.080.20
11.040.01
ISO/TC 210
ISO 15223-2:2010
Medical devices -- Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation
60.60 01.080.20
11.040.01
ISO/TC 210
ISO 15225:2010
Medical devices -- Quality management -- Medical device nomenclature data structure
90.92 11.040.01
35.240.80
ISO/TC 210
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
90.92 11.040.01ISO/TC 210
ISO/TS 19218-1:2011
Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes
90.20 11.040.01
03.120.10
ISO/TC 210
ISO/TS 19218-1:2011/Amd 1:2013
60.60 11.040.01
03.120.10
ISO/TC 210
ISO/TS 19218-2:2012
Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes
60.60 11.040.01
03.120.10
ISO/TC 210
ISO/TR 24971:2013
Medical devices -- Guidance on the application of ISO 14971
60.60 11.040.01ISO/TC 210
IEC 62304:2006
Medical device software -- Software life cycle processes
90.92 11.040.01
35.240.80
ISO/TC 210
IEC 62366:2007
Medical devices -- Application of usability engineering to medical devices
90.92 11.040.01ISO/TC 210
IEC 62366:2007/Amd 1:2014
60.60 11.040.01ISO/TC 210
IEC/TR 80002-1:2009
Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
60.60 35.240.80
11.040.01
ISO/TC 210
ISO 80369-1:2010
Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements
90.92 11.040.20
11.040.10
ISO/TC 210