INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY
CURRENTS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM
UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility (EMC)
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization, disinfection and
compatibility
46 Human errors
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
52 Abnormal operation and fault conditions
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and layout
SECTION 101 - ADDITIONAL REQUIREMENTS RELATING TO SAFETY
101 Charging time
102 Internal electrical power source
103 Endurance
104 Synchronizer
105 Recovery of the MONITOR/ECG INPUT after defibrillation
106 Disturbance to the monitor from charging or internal
discharging
Appendix L References - Publications mentioned in this
Standard
Annex AA (informative) General guidance and rationale
Annex BB (informative) AUTOMATED EXTERNAL DEFIBRILLATORS:
background and rationale
Annex ZA (normative) Normative references to international
publications with their corresponding European
publications
Annex ZB (informative) Other international publications
mentioned in this standard with the reference of
the European publications