BS EN 62304 : 2006

Foreword
Introduction
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
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EC Directives
Bibliography

Specifies 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.