Name: AAMI/ISO TIR 80002-2:2017
Brand: AAMI
Price: 522.17 AUD

MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

18-08-2017

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO TR 80002-2
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	ISO/TC 210
DocumentType	Standard
ISBN	978-1-57020-670-2
Pages	103
PublisherName	Association for the Advancement of Medical Instrumentation
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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AAMI/ISO TIR 80002-2:2017

MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory