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
hazardous outputs
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 AA (informative) - Particular guidance and rationale
Annex BB (normative) - Design requirements and recommendations for
MEDICAL BEDS
Annex CC (informative) - Particular guidance for assessing risk of
entrapment in v-shaped openings
Annex ZA (normative) - Normative references to international
publications with their corresponding European publications
Annex ZZ (informative) - Coverage of Essential Requirements of
EC Directives
Bibliography
Index of defined terms used in this particular standard