FOREWORD
1 Scope, object and related
standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for
testing of ME EQUIPMENT
6 Classification of ME EQUIPMENT
and ME SYSTEMS
7 ME EQUIPMENT identification,
marking and documents
8 Protection against electrical
HAZARDS from ME EQUIPMENT
9 Protection against MECAHNICAL
HAZARDS of ME EQUIPMENT and
ME SYSTEMS
10 Protection against unwanted
and excessive radiation HAZARDS
11 Protection against excessive
temperatures and other HAZARDS
12 * Accuracy of controls and
instruments and protection
against hazardous outputs
13 HAZARDOUS SITUATIONS and fault
conditions
14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility
of ME EQUIPMENT and ME SYSTEMS
101 * Charging time
102 Internal electrical power source
103 * Endurance
104 * Synchronizer
105 * Recovery of the MONITOR and/or
ECG input after defibrillation
106 * Disturbance to the MONITOR from
charging or internal discharging
107 * Requirements for RHYTHM
RECOGNITION DETECTOR
108 DEFIBRILLATOR ELECTRODES
109 * External pacing (U.S.)
202 * Electromagnetic compatibility -
Requirements and tests
Annexes
Annex C (informative) - Guide to marking
and labelling requirements for
ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance
and rationale
Annex BB (informative) - Mapping between
the elements of the second
edition of IEC 60601-2-4 and
IEC 60601-2-4:2010
Bibliography