Active
Standard
Most Recent
ISO TR 80002-2:2017
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
Preview
Summary
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.
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.
Technical characteristics
| Publisher | International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) |
| Publication Date | 06/13/2017 |
| Edition | 1.0 |
| Page Count | 84 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
No products.
No products.
No products.