Items to be displayed:
| Standard and/or project | Stage | ICS |
|---|---|---|
| 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 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements | 90.60 | 11.040.25 |
| ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings | 90.60 | 11.040.25 |
| ISO/CD 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes | 30.60 | 11.040.01 03.120.10 |
| ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes | 90.92 | 03.120.10 11.040.01 |
| ISO 13485:2003/Cor 1:2009 | 60.60 | 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 | 11.040.01 03.120.10 |
| ISO 14971:2007 Medical devices -- Application of risk management to medical devices | 90.93 | 11.040.01 |
| 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 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/AWI 15225 Medical devices -- Quality management -- Medical device nomenclature data structure | 20.00 | |
| ISO 15225:2010 Medical devices -- Quality management -- Medical device nomenclature data structure | 90.92 | 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 | 90.92 | 11.040.01 |
| ISO/NP 16142-1 Medical 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 standards | 10.99 | |
| ISO/NP 16142-2 Medical 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 standards | 10.99 | |
| ISO/CD 18250 Connectors for enteral feed/solution reservoirs | 30.60 | 11.040.25 |
| ISO/TS 19218-1:2011 Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes | 60.60 | 11.040.01 03.120.10 |
| ISO/TS 19218-1:2011/Amd 1:2013 | 60.60 | 11.040.01 03.120.10 |
| 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/TR 24971 Guidance on the application of ISO 14971 | 60.00 | 11.040.01 |
| IEC 62304:2006 Medical device software -- Software life cycle processes | 90.92 | 11.040.01 35.240.80 |
| IEC/CD 62304 Medical device software -- Software life cycle processes | 30.60 | 11.040.01 35.240.80 |
| IEC 62366:2007 Medical devices -- Application of usability engineering to medical devices | 90.92 | 11.040.01 |
| IEC 62366:2007/DAmd 1 | 40.60 | 11.040.01 |
| IEC/CD 62366-1 Medical devices -- Part 1: Application of usability engineering to medical devices | 30.60 | 11.040.01 |
| 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/AWI TR 80002-2 Medical device software -- Part 2: Validation of software for regulated processes | 20.00 | |
| ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements | 60.60 | 11.040.20 11.040.10 |
| IEC/CD 80369-2 Small bore connectors for liquids and gases in healthcare applications -- Part 2: Connectors for breathing systems and driving gases applications | 30.60 | 11.040.20 11.040.10 |
| IEC/CD 80369-3 Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications | 30.60 | 11.040.25 |
| IEC/CD 80369-5 Small-bore connectors for liquids and gases in healthcare applications -- Part 5: Connectors for limb cuff inflation applications | 30.60 | 11.040.25 |
| IEC/CD 80369-6 Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications | 30.60 | 11.040.25 |
| ISO/DIS 80369-7 Small bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications | 40.00 | 11.040.25 |
| ISO/CD 80369-20 Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods | 30.99 | 11.040.25 |
