EN 60601-1-4:1996/A1:1999

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
Table DFDD.1 - Suggested correlation of the documentation
requirement to the DEVELOPMENT LIFE-CYCLE PHASES
Figures
201 Content of RISK MANAGEMENT FILE and RISK
             MANAGEMENT SUMMARY
CCC.1 Risk chart
CCC.2 RISK management process
DDD.1 DEVELOPMENT LIFE-CYCLE model for PEMS
EEE.1 Examples of PEMS/PESS structures
Annexes
AAA Terminology - Index of defined terms
BBB Rationale
CCC RISK concepts
DDD DEVELOPMENT LIFE-CYCLE model
EEE Examples for PEMS/PESS structures
FFF Bibliography

Applicable to the safety of medical electrical equipment and medical electrical systems including programmable electronic subsystems (PEMS). Defines requirements for the design process of PEMS and is also the basis of requirements of Particular Standards, which includes serving as a guide to safety requirements for managing and reducing risk.