BS 5724-2.31(1995) : 1995
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - SPECIFICATION FOR EXTERNAL CARDIAC PACEMAKERS WITH INTERNAL POWER SOURCE
31-07-2009
23-11-2012
Committees responsible
National foreword
Foreword
Introduction
Section One: General
1. Scope and object
2. Terminology and definitions
5. Classification
6. Identification, marking and documents
7. Power input
Section Two: Environmental conditions
Section Three: Protection against electrical shock hazards
14. Requirements related to classification
19. Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
CURRENTS
Section Four: Protection against mechanical hazards
Section Five: Protection against hazards from unwanted
or excessive radiation
36. Electromagnetic compatibility
Section Six: Protection against hazards of ignition of
flammable anaesthetic mixtures
Section Seven: Protection against excessive temperatures
and other safety hazards
44. Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization and disinfection
49. Interruption of the power supply
Section Eight: Accuracy of operating data and protection
against hazardous output
50. Accuracy of operating data
51. Protection against hazardous output
Section Nine: Abnormal operation and fault conditions/
environmental tests
Section Ten: Constructional requirements
56. Components and general assembly
Figures
101 Measuring circuit for the MAXIMUM TRACKING RATE
102. Initial oscilloscope display when measuring
MAXIMUM TRACKING RATE
Appendix/Annexes
Appendix L. References - Publications mentioned in this
Standard
Annex AA General guidance and rationale
Annex BB Bibliography
Annex ZA (normative) Other international publications
quoted in this standard with the references
of the relevant European publications
Annex ZB (informative) Other international publications
quoted in this standard with the references of
the relevant European publications
ALSO NUMBERED AS BS EN 60601 PT2-31. Specifies the particular safety requirements for external pacemakers powered by an internal electrical power source. Not applicable to equipment which can be directly or indirectly connected to a supply mains. Does not apply to pacing leads, or other equipment for cardiac stimulation which either: provides antiachycardia therapy beyond high burst pacing; or forms an integral part of equipment with other functions; or applies the stimulus across the thorax externally or in the oesophagus; or provides pacing system analysis functions.
Committee |
CH/150/6
|
DevelopmentNote |
Supersedes 91/53412 DC. (11/2005)
|
DocumentType |
Standard
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
EN 50061 : 88 AMD 1 95 | SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 60086-2:2015 | Primary batteries - Part 2: Physical and electrical specifications |
IEC 60086-1:2015 | Primary batteries - Part 1: General |
ISO 5841-1:1989 | Cardiac pacemakers Part 1: Implantable pacemakers |
BS EN 60801-2:1993 | Electromagnetic compatibility for industrial-process measurement and control equipment Electrostatic discharge requirements |
NFC 74 308 : 1988 | ELECTROMEDICAL EQUIPMENT - ELECTRICALLY-OPERATED PACEMAKERS |
IEC 60801-2:1991 | Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements |
BS EN 60601-1-2:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests |
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