BS 5724-1.4(1997) : 1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - GENERAL REQUIREMENTS FOR PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
23-11-2012
30-11-2006
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
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| 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)
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| DocumentType |
Standard
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| PublisherName |
British Standards Institution
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| Status |
Superseded
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| SupersededBy |