ISO/TR 80002-2:2017 PDF Download
Standard EN Sample
Medical device software — Part 2: Validation of software for medical device quality systems
Also Known As:
SKU163931358
Published by
International Organization for Standardization
ISO
Publication Date2017-06
Pages CountPages92
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.
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.
Details
| Edition | 1 |
| ICS Codes | 11.040.01 - Medical equipment in general 35.240.80 - IT applications in health care technology |
| Language(s) | English |
| File Size | 1.6 MB |
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