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
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
Annexes
Annex E (informative)- Examples of the connection
of the measuring device (MD) for measurement
of the PATIENT LEAKAGE CURRENT and PATIENT
AUXILIARY CURRENT
Annex G (normative) - Protection against HAZARDS of
ignition of flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
LIFE-CYCLE and documentation
Annex I (informative) - ME SYSTEMS aspects
Annex J (informative) - Survey of insulation paths
Annex K (informative) - Simplified PATIENT LEAKAGE CURRENT
diagrams
Annex L (normative) - Insulated winding wires for use
without interleaved insulation
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Abbreviations
Bibliography
Index of defined terms used in this particular standard