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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
30-11-2006
23-11-2012
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Superseded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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