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 form 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
201.101 LABORATORY ACCURACY of a SCREENING
THERMOGRAPH
201.102 SCREENING THERMOGRAPH ALARM CONDITIONS
202 Electromagnetic disturbances - Requirements
and tests
206 USABILITY
Annexes
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT And ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Annex BB (normative) - CALIBRATION SOURCE
Annex CC (informative) - Reference to the essential principles
Bibliography
Alphabetized index of defined terms used in this particular
standard