BS ISO 11197 : 2016
Current
The latest, up-to-date edition.
MEDICAL SUPPLY UNITS
Hardcopy , PDF
English
01-01-2016
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
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