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PD ISO/TR 80002-2:2017

PD ISO/TR 80002-2:2017

Current

Current

The latest, up-to-date edition.

Medical device software Validation of software for medical device quality systems

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2017

Publisher

British Standards Institution

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.

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.

Committee
CH/62/1
DocumentType
Standard
Pages
94
PublisherName
British Standards Institution
Status
Current

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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Hardcopy - English
PDF - English
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