AAMI DF80:2003

Glossary of equivalent standards
Committee representation
Background
FOREWORD
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
107 Defibrillator electrodes (U.S.)
108 External pacing (U.S.)
Annexes
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 CC (informative) - General guidance and rationale
                         for additional U.S. requirements (U.S.)
Annex DD (informative) - Historical background on
                         defibrillation waveforms (U.S.)
Annex EE (informative) - Cited references in Annexes CC
                         and DD (U.S.)

Describes the requirements for the safety of CARDIAC DEFIBRILLATORS as defined in 2.1.101, hereinafter referred to as EQUIPMENT.