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BS EN ISO 80601-2-55 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-55: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY GAS MONITORS
Hardcopy , PDF
English
03-16-2018
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
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
212 General requirements, tests and guidance for
ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT
and MEDICAL ELECTRICAL SYSTEMS
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) - Reference to the essential principles
Annex EE (informative) - Alphabetized index of defined terms
used in this document
Annex ZA (informative) - Relationship between this European
Standard and the the essential requirements of Directive
93/42/EEC [OJ L 169] aimed to be covered
Bibliography
BS EN ISO 80601-2-55.
| Committee |
CH/121/1
|
| DocumentType |
Draft
|
| Pages |
74
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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