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EVS-EN ISO 80601-2-85:2021

Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (ISO 80601-2-85:2021)

General information
Valid from 03.05.2021
Base Documents
EN ISO 80601-2-85:2021; ISO 80601-2-85:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
03.05.2021
Main
This particular standard applies to basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS), which is a unique application of NIRS in that it employs multiple wavelengths of light energy and time-resolved (frequency or time domain) and/or spatially resolved methods to derive a quantitative measure of tissue oxygen saturation of haemoglobin within the field of the NIRS sensor. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME EQUIPMENT for those environments of use. Not included within the scope of this particular standard are: a) Invasive tissue or vascular oximeters b) Device measuring dissolved oxygen c) Functional NIRS device covered by IEC 80601-2-71, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes d) Pulse oximeter covered by ISO 80601-2-61, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes; however, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. NOTE: a manufacturer may claim monitoring of tissue other than cerebral, which is not covered by this standard.
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