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