I.S. EN ISO 80601-2-55:2018
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
01-01-2018
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
European foreword
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
201.10Protection against unwanted and
excessive radiation HAZARDS
201.11Protection against excessive temperatures
and other HAZARDS
201.12Accuracy of controls and instruments
and protection against hazardous outputs
201.13HAZARDOUS SITUATIONS and fault conditions
201.14PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15Construction of ME EQUIPMENT
201.16ME SYSTEMS
201.17Electromagnetic compatibility of ME
EQUIPMENT and ME SYSTEMS
201.101 Interfering gas and vapour effects
201.102 Gas leakage
201.103 Port connectors for DIVERTING RGMs
201.104 Sampling flowrate
201.105 Contamination of breathing systems
201.106 FUNCTIONAL CONNECTION
202 Electromagnetic disturbances - Requirements and tests
206 USABILITY
208 General requirements, tests and guidance for
ALARM SYSTEMS in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
211 General requirements, tests and guidance
for medical electrical equipment and medical
electrical systems used in the home healthcare environment
212 General requirements, tests and guidance for
MEDICAL ELECTRICAL EQUIPMENT and
MEDICAL ELECTRICAL SYSTEMS intended
for use in the EMERGENCY MEDICAL SERVICES
ENVIRONMENT
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Test gas mixtures for calibration
Annex CC (informative) - Data interface requirements
Annex DD (informative) - Alphabetized index of defined
terms used in this document
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the essential requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered
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