FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.1.1 Scope
201.1.2 Object
201.1.3 Collateral Standards
201.1.4 Particular standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.4.3 ESSENTIAL PERFORMANCE
201.4.101 Additional ESSENTIAL PERFORMANCE
requirements
201.5 General requirements for testing of ME EQUIPMENT
201.5.3 Ambient temperature, humidity, atmospheric
pressure
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.6.2 Protection against electrical shock
201.6.6 Mode of operation
201.7 ME EQUIPMENT identification, marking and documents
201.7.2 Marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts
201.7.9.2 Instructions for use
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
201.12.1 Accuracy of controls and instruments
201.12.1.101 Automated analysis
201.12.4 Protection against hazardous output
201.12.4.4 Incorrect output
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.15.4 ME EQUIPMENT components and general assembly
201.16 ME SYSTEMS
201.16.5 Separation devices
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME
SYSTEMS
202 Electromagnetic compatibility - Requirements and tests
202.6.1.1 Protection of radio services
202.6.2 IMMUNITY
202.6.2.1 General
202.6.2.3 Radiated RF electromagnetic fields
203 General requirements for radiation protection in diagnostic
X-ray equipment
206 Usability
208 General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical
systems
209 Requirements for the reduction of environmental impacts
210 Process requirements for the development of therapeutic
closed-loop controllers
Annex AA (informative) - Guidance and rationale
Index of defined terms used in this particular standard