AAMI IEC 62304 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES
Hardcopy , PDF
09-13-2021
English
01-01-2006
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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Superseded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 | 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.