SN EN 60601-2-31 : 1995 AMD 1 1998

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 5724 SECTION 2.31 1995 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 antitachycardia 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.