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AAMI IEC 62304 : 2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
Available format(s)

Hardcopy , PDF

Superseded date

09-13-2021

Language(s)

English

Published date

01-01-2006

Glossary of equivalent standards
Committee representation
Foreword
Introduction
Introduction to Amendment 1
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Software development PROCESS
6 Software maintenance PROCESS
7 Software RISK MANAGEMENT PROCESS
8 Software configuration management
  PROCESS
9 Software problem resolution PROCESS
Annex A (informative) - Rationale for the
        requirements of this standard
Annex B (informative) - Guidance on the
        provisions of this standard
Annex C (informative) - Relationship to
        other standards
Annex D (informative) - Implementation
Bibliography
Index of defined terms

Describes the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.

DevelopmentNote
Supersedes AAMI SW68 (08/2006)
DocumentType
Standard
Pages
181
ProductNote
NEW CHILD AMD 1 IS ADDED
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 62304:2006+AMD1:2015 CSV Identical

IEEE 730-2014 REDLINE IEEE Standard for Software Quality Assurance Processes
AAMI TIR45 : 2012 GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE

ISO/IEC 15504-5:2012 Information technology Process assessment Part 5: An exemplar software life cycle process assessment model
IEEE 610.12-1990 IEEE Standard Glossary of Software Engineering Terminology
ISO/IEC 25010:2011 Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO/IEC 33001:2015 Information technology Process assessment Concepts and terminology
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO/IEC 14764:2006 Software Engineering Software Life Cycle Processes Maintenance
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
ISO/IEC 12207:2008 Systems and software engineering Software life cycle processes
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO/IEC 33004:2015 Information technology Process assessment Requirements for process reference, process assessment and maturity models

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