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
202 Electromagnetic compatibility - Requirements
and tests
208 General requirements, tests and guidance for
ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT
and MEDICAL ELECTRICAL SYSTEMS
210 Requirements for the development of physiologic
closed-loop controllers
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance
and rationale
Annex BB (normative) - Determination of the
LAGGING MATERIAL
Annex CC (normative) - Determination of heat
transfer towards the PATIENT
Annex DD (normative) - Determination of heat
transfer away from the PATIENT
Annex EE (normative) - Conditions of adequate
heat discharge
Annex FF (normative) - Test procedure for maximum
CONTACT SURFACE TEMPERATURE
for FORCED AIR DEVICES
Annex GG (normative) - Test procedure for maximum
CONTACT SURFACE TEMPERATURE for FORCED AIR
DEVICES under SINGLE FAULT CONDITION
Annex HH (normative) - Safety test procedure for
average CONTACT SURFACE TEMPERATURE for
FORCED AIR DEVICES
Bibliography
Index of defined terms used in this particular standard