PD ISO/TR 80002-2:2017
Current
The latest, up-to-date edition.
Medical device software Validation of software for medical device quality systems
Hardcopy , PDF
English
10-31-2017
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Software validation discussion
5 Software validation and critical thinking
6 Documentation
7 Prerequisite processes
Annex A (informative) - Toolbox
Annex B (informative) - Risk management and
risk-based approach
Annex C (informative) - Examples
Bibliography
Pertains 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.
| Committee |
CH/62/1
|
| DocumentType |
Standard
|
| Pages |
94
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
This document 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 ISO13485 .
This document 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.
| Standards | Relationship |
| ISO/TR 80002-2:2017 | Identical |
| 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/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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