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
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 - Part 1-2: General
requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements and tests
203 Medical electrical equipment - Part 1: General
requirements for safety - 3. Collateral standard:
General requirements for RADIATION protection in
diagnostic X-ray equipment
206 Medical electrical equipment - Part 1-6: General
requirements for safety - Collateral standard:
Usability
208 Medical electrical equipment - Part 1-8: General
requirements for safety - Collateral Standard: General
requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
209 Medical electrical equipment - Part 1-9: General requirements
for basic safety and essential performance - Collateral
Standard: Requirements for the reduction of environmental
impacts
210 Medical electrical equipment - Part 1-10: General requirements
for basic safety and essential performance - Collateral
Standard: Process requirements for the development of
therapeutic closed-loop controllers
211 Medical electrical equipment - Part 1-11: General
requirements for basic safety and essential performance
- Collateral Standard: Requirements for medical electrical
equipment and medical electrical system used in the home
healthcare environment
Annex BB (informative) - Test of X-RAY TUBE ASSEMBLIES for
pressure-related risks
BB.1 Introduction
BB.2 General considerations
BB.3 General start-conditions for the typical tests
BB.4 Disintegration inducement for glass-metal X-RAY TUBES
BB.5 Disintegration inducement for metal-ceramic X-RAY TUBES
BB.6 Pass/fail criteria
INDEX OF DEFINED TERMS USED IN THIS PARTICULAR STANDARDô