Темы (или пункты), которые надо показать:
| Стандарт и/или проект | Стадия | МКС |
|---|---|---|
| ISO/CD 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes | 30.60 | 11.040.01 03.120.10 |
| ISO/AWI 15225 Medical devices -- Quality management -- Medical device nomenclature data structure | 20.00 | |
| 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/PRF TR 24971 Guidance on the application of ISO 14971 | 50.20 | 11.040.01 |
| IEC/CD 62304 Medical device software -- Software life cycle processes | 30.60 | 11.040.01 35.240.80 |
| 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 |
| ISO/AWI TR 80002-2 Medical device software -- Part 2: Validation of software for regulated processes | 20.00 | |
| 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 |
