IEC 62304 : 1.1

Table of Contents

FOREWORD
INTRODUCTION
INTRODUCTION to Amendment
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

Abstract

Specifies the life cycle requirements for MEDICAL DEVICE SOFTWARE.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Electrotechnical Committee
Pages
ISBN
Committee	TC 62