BS EN 60601-1-4:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems
Hardcopy , PDF
30-11-2006
English
15-04-2001
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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
Applicable to the safety of medical electrical equipment and medical electrical systems including programmable electronic subsystems (PEMS). Defines requirements for the design process of PEMS and is also the basis of requirements of Particular Standards, which includes serving as a guide to safety requirements for managing and reducing risk.
| Committee |
CH/62/1
|
| DevelopmentNote |
Also numbered as BS 5724-1.4(1997) and IEC 60601-1-4. (03/2001) Supersedes 94/505432 DC and 98/562192 DC. (05/2005) Inactive for the new design. (05/2011)
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| UNE-EN 60601-1-4:1997 | Identical |
| EN 60601-1-4:1996/A1:1999 | Identical |
| NF EN 60601-1-4 : 1999 AMD 1 2005 | Identical |
| EN 60601-1-4:1996 | Identical |
| IEC 60601-1-4:1996/AMD1:1999 | Identical |
| I.S. EN 60601-1-4:1998 | Identical |
| SN EN 60601-1-4 : 1996 AMD 1 1999 | Identical |
| DIN EN 60601-1-4 : 2001-04 | 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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