FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME
EQUIPMENT
201.6 Classification of ME EQUIPMENT and
ME SYSTEMS
201.7 ME EQUIPMENT identification, marking
and documents
201.8 Protection against electrical HAZARDS
from ME EQUIPMENT
201.9 Protection against MECHANICAL
HAZARDS of ME EQUIPMENT and ME
SYSTEMS
201.10 Protection against unwanted and
excessive radiation HAZARDS
201.11 Protection against excessive temperatures
and other HAZARDS
201.12 Accuracy of controls and instruments and
protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault
conditions
201.14 PROGRAMMABLE ELECTRICAL
MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME
EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility - Requirements
and tests
Annexes
Annex AA (informative) - Particular guidance and
rationale
Annex BB (informative) - ELECTRODES, their positions,
identifications and colour codes
Annex CC (informative) - LEADS, their identification
and colour codes (other than those specified in
201.12.4.102)
Annex DD (informative) - Polarity of PATIENT LEADS
(other than those specified in 201.12.4.102)
Annex EE (informative) - Additional marking of
ELECTRODES
Annex FF (informative) - Definitions and rules for the
measurement of ELECTROCARDIOGRAMS
Annex GG (informative) - Calibration and test data sets
Annex HH (informative) - CTS test atlas
Bibliography
Index of defined terms used in this particular standard