DS/ISO TR 80002-2
Medical device software – Part 2: Validation of software for medical device quality systems
active, Most Current
| Organization: | DS |
| Publication Date: | 19 June 2017 |
| Status: | active |
| Page Count: | 94 |
| ICS Code (IT applications in health care technology): | 35.240.80 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
ISO/TR 80002-2:2017(E) 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. ISO/TR 80002-2:2017 applies to - software used in the quality management system, - software used in production and service provision, and - software used for the monitoring and measurement of requirements. It does not apply to - software used as a component, part or accessory of a medical device, or - software that is itself a medical device.
Document History
DS/ISO TR 80002-2
June 19, 2017
Medical device software – Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017(E) applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other...