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BS 5724-1.4(1997) : 1997

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Superseded date

30-11-2006

Published date

23-11-2012

Publisher

British Standards Institution

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Superseded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

Standards Relationship
EN 60601-1-4:1996/A1:1999 Identical

IEC 61025:2006 Fault tree analysis (FTA)
ISO/IEC 15026:1998 Information technology System and software integrity levels
IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 61508-5:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508)
IEC 61508-4:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (see Functional Safety and IEC 61508)
IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
ISO/IEC 12119:1994 Information technology Software packages Quality requirements and testing
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
IEC 60880:2006 Nuclear power plants - Instrumentation and control systems important to safety - Software aspects for computer-based systems performing category A functions
ISO 9001:2015 Quality management systems — Requirements
EN 29000-3 : 1993 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - GUIDELINES FOR THE APPLICATION OF ISO 9001 TO THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE
HD 501 : 200S1 MEDICAL RADIOLOGY - TERMINOLOGY
IEC 61508-6:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (see Functional Safety and IEC 61508)
IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
IEC 61508-7:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures (see Functional Safety and IEC 61508)
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 61508-2:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems (see Functional Safety and IEC 61508)
ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software

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