Items to be displayed:
| Standard and/or project | Stage | TC |
|---|---|---|
| ISO/CD 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes | 30.60 | ISO/TC 210 |
| ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes | 90.92 | ISO/TC 210 |
| ISO 13485:2003/Cor 1:2009 | 60.60 | ISO/TC 210 |
| ISO/TR 14969:2004 Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003 | 90.93 | ISO/TC 210 |
| ISO 14971:2007 Medical devices -- Application of risk management to medical devices | 90.93 | ISO/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 | 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 | ISO/TC 210 |
| ISO 15225:2010 Medical devices -- Quality management -- Medical device nomenclature data structure | 90.92 | ISO/TC 210 |
| ISO 15378:2011 Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) | 60.60 | ISO/TC 76 |
| 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 | ISO/TC 210 |
| ISO/PAS 18761:2013 Use and handling of medical devices covered by the scope of ISO/TC 84 -- Risk assessment on mucocutaneous blood exposure | 60.60 | ISO/TC 84 |
| ISO/TS 19218-1:2011 Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes | 60.60 | ISO/TC 210 |
| ISO/TS 19218-1:2011/Amd 1:2013 | 60.60 | ISO/TC 210 |
| ISO/TS 19218-2:2012 Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes | 60.60 | ISO/TC 210 |
| ISO/PRF TR 24971 Guidance on the application of ISO 14971 | 50.20 | ISO/TC 210 |
| IEC/CD 62304 Medical device software -- Software life cycle processes | 30.60 | ISO/TC 210 |
| IEC 62304:2006 Medical device software -- Software life cycle processes | 90.92 | ISO/TC 210 |
| IEC 62366:2007 Medical devices -- Application of usability engineering to medical devices | 90.92 | ISO/TC 210 |
| IEC 62366:2007/DAmd 1 | 40.60 | ISO/TC 210 |
| IEC/CD 62366-1 Medical devices -- Part 1: Application of usability engineering to medical devices | 30.60 | ISO/TC 210 |
| IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities | 60.60 | ISO/TC 215 |
| IEC/WD 80001-2 Application of risk management for IT-networks incorporating medical devices -- Part 2: Guidance on distributed alarm systems | 20.20 | ISO/TC 215 |
| IEC/TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices -- Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples | 60.60 | ISO/TC 215 |
| IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices -- Part 2-2: Guidance for the communication of medical device security needs, risks and controls | 60.60 | ISO/TC 215 |
| IEC/TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices -- Part 2-3: Guidance for wireless networks | 60.60 | ISO/TC 215 |
| IEC/TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for Healthcare Delivery Organizations | 60.60 | ISO/TC 215 |
| IEC/TR 80002-1:2009 Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software | 60.60 | ISO/TC 210 |
