AAMI IEC 62304 : 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.