ISO TR 80002-2:2017
Medical device software - Part 2: Validation of software for medical device quality systems
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2017 |
| No. of Pages | 84 |
| ICS Classification | 35.240.80 IT applications in health care technology 11.040.01 Medical equipment in general |
| Committee | TC 62/SC 62A |
| Available for Purchase | For sale in Singapore only |
| Adoption | IEC |