National Foreword
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
for ME EQUIPMENT
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
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EU Directives