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BS EN 60601-1-4:1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems

Available format(s)

Hardcopy , PDF

Superseded date

11-30-2006

Language(s)

English

Published date

04-15-2001

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

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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