ISO/TR 80002-2:2017
Current
The latest, up-to-date edition.
Medical device software — Part 2: Validation of software for medical device quality systems
Hardcopy , PDF
English
13-06-2017
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.
| DocumentType |
Technical Report
|
| Pages |
84
|
| ProductNote |
THIS STANDARD ALSO REFERS TO ISO 12207
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| PD ISO/TR 80002-2:2017 | Identical |
| NEN NPR ISO/TR 80002-2 : 2017 | Identical |
| AAMI/ISO TIR 80002-2:2017 | Identical |
| ABNT ISO/TR 80002-2:2021 | Identical |
| ISO 13485 - PRACTICAL GUIDE : 2016 | ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE |
| IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| SA HB 13485:2020 | AS ISO 13485:2017 - Medical devices - A practical guide |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
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