ISO/TC 210
| Projekta Nr. | ISO/TR 80002-2:2017 |
|---|---|
| Nosaukums | <p>ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.</p> <p>ISO/TR 80002-2:2017 applies to</p> <p>- software used in the quality management system,</p> <p>- software used in production and service provision, and</p> <p>- software used for the monitoring and measurement of requirements.</p> <p>It does not apply to</p> <p>- software used as a component, part or accessory of a medical device, or</p> <p>- software that is itself a medical device.</p> |
| Reģistrācijas numurs (WIID) | 60044 |
| Darbības sfēra | <p>ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.</p> <p>ISO/TR 80002-2:2017 applies to</p> <p>- software used in the quality management system,</p> <p>- software used in production and service provision, and</p> <p>- software used for the monitoring and measurement of requirements.</p> <p>It does not apply to</p> <p>- software used as a component, part or accessory of a medical device, or</p> <p>- software that is itself a medical device.</p> |
| Statuss | Standarts spēkā |
| ICS grupa | 11.040.01 35.240.80 |