Standard Svensk standard · SS-EN ISO 80601-2-85:2021

Elektrisk utrustning för medicinskt bruk - Del 2-85: Särskilda krav på grundläggande säkerhet och funktion på cerebral vävnadsoximeter (ISO 80601-2-85:2021)

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Standard Svensk standard · SS-EN ISO 80601-2-85:2021

Elektrisk utrustning för medicinskt bruk - Del 2-85: Särskilda krav på grundläggande säkerhet och funktion på cerebral vävnadsoximeter (ISO 80601-2-85:2021)
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Omfattning
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.

Ämnesområden

Utrustning för anestesi, respiration och återupplivning (11.040.10)


Köp denna standard

Standard Svensk standard · SS-EN ISO 80601-2-85:2021

Elektrisk utrustning för medicinskt bruk - Del 2-85: Särskilda krav på grundläggande säkerhet och funktion på cerebral vävnadsoximeter (ISO 80601-2-85:2021)
Prenumerera på standarden - Läs mer Dölj
Pris: 1 595 SEK
standard ikon pdf

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Pris: 1 595 SEK
standard ikon

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Pris: 2 552 SEK
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Produktinformation

Språk: Engelska

Framtagen av: Anestesi- och respiratorutrustning, SIS/TK 329

Internationell titel: 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)

Artikelnummer: STD-80028743

Utgåva: 1

Fastställd: 2021-04-21

Antal sidor: 120