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BS 5724-1.4(1997) : 1997

Superseded

Superseded

View Superseded by

MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

Published date

11-23-2012

Superseded date

11-30-2006

Superseded by

BS EN 60601-1 : 2006

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Summarise this standard

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
ZA (normative) Normative references to international
publications with their corresponding European publications

Committee
CH/62/1
DevelopmentNote
Also Numbered as BS EN 60601-1.4 & IEC 60601-1-4. (03/2001) Supersedes 94/505432 DC. (05/2005) Inactive for the new design. (05/2011)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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