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 Medical electrical equipment — Parts 1-2 General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements
and tests
206 Medical electrical equipment — Parts 1-6 General requirements for basic safety and
essential performance — Collateral standard: Usability
Annex A A (informative) Rationale
Annex B B (informative) Tests during production
Annex C C (informative) Documentation
Annex D D (informative) Terminology — Alphabetical index of defined terms
Bibliography