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BS EN ISO 80601-2-55:2018+A1:2023

BS EN ISO 80601-2-55:2018+A1:2023

$215.11

Medical electrical equipment – Particular requirements for the basic safety and essential performance of respiratory gas monitors

Published By Publication Date Number of Pages
BSI 2023 78
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PDF Catalog

PDF Pages PDF Title
2 undefined
10 Annex ZA(informative)Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
19 201.1 Scope, object and related standards
201.1.1 *Scope
201.1.2 Object
20 201.1.3 Collateral standards
201.1.4 Particular standards
21 201.2 Normative references
22 201.3 Terms and definitions
24 201.4 General requirements
25 201.5 General requirements for testing of me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking, and documents
31 201.8 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
32 201.11 Protection against excessive temperatures and other hazards
34 201.12 Accuracy of controls and instruments and protection against hazardous outputs
40 201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
42 201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 *Interfering gas and vapour effects
43 201.102 *Gas leakage
201.103 *Port connectors for diverting rgms
201.104 *Sampling flowrate
201.105 *Contamination of breathing systems
201.106 Functional connection
45 202 Electromagnetic disturbances — Requirements and tests
206 Usability
46 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
48 211 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

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BS EN ISO 80601-2-55:2018+A1:2023
$215.11