I.S. EN 60601-1-4:1998

INTRODUCTION
SECTION 1: GENERAL
1 Scope, object and relationship to other standards
  1.201 Scope
  1.202 Object
  1.2039 Relationship to other standards
SECTION 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
Annex AAA (normative) Terminology - Index of defined
          terms
Annex BBB (informative) Rationale
Annex CCC (informative) Risk Concepts
Annex DDD (informative) Development Life-cycle
Annex EEE (informative) Examples for PEMS/PESS structures
Annex FFF (informative) Bibliography
Annex ZA (normative) Normative references to international
         publications with their corresponding European
         publications
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

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. Also covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents.