IEC 60601-1-4:1996+AMD1:1999 CSV

FOREWORD
INTRODUCTION
SECTION 1: GENERAL
1 Scope, object and relationship to other standards
   1.201 Scope
   1.202 Object
   1.203 Relationship to other standards
2 Terminology and definitions
   2.201 Defined terms
   2.202 Degrees of requirements and miscellaneous terms
6 Identification, marking and documents
   6.8 ACCOMPANYING DOCUMENTS
SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL
           TESTS
52 Abnormal operation and fault conditions
   52.201 Documentation
   52.202 RISK management plan
   52.203 DEVELOPMENT LIFE-CYCLE
   52.204 RISK management process
   52.205 Qualification of personnel
   52.206 Requirement specification
   52.207 Architecture
   52.208 Design and implementation
   52.209 VERIFICATION
   52.210 VALIDATION
   52.211 Modification
   52.212 Assessment
Annexes
AAA - Terminology - Index of defined terms
BBB - Rationale
CCC - RISK concepts
DDD - DEVELOPMENT LIFE-CYCLE
EEE - Examples for PEMS/PESS structures
FFF - Bibliography

Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk. This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents. This consolidated version consists of the first edition (1996) and its amendment 1 (1999). Therefore, no need to order amendment in addition to this publication.