BS ISO 11197 : 2016

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 - part 1-2
    General requirements for BASIC SAFETY and
    ESSENTIAL PERFORMANCE - Collateral
    standard: Electromagnetic disturbances -
    Requirements and tests
206 MEDICAL ELECTRICAL EQUIPMENT - part 1-6
    General requirements for BASIC SAFETY and
    ESSENTIAL PERFORMANCE - Collateral
    standard: Usability
Annex AA (informative) - Rationale
Bibliography

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT.