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MSZ EN ISO 80601-2-85:2021

Dokumentumazonosító

177245

Cím

Gyógyászati villamos készülékek. 2-85. rész: Az agyszöveti oximéter alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (ISO 80601-2-85:2021)

Angol cím

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)

Alkalmazási terület

201.1 Scope, object and related standards Clause 1 of the general standard applies, except as follows. NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020. 201.1.1 * Scope Replacement: This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document 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. NOTE 1 Cerebral tissue oximeters are sometimes referred to as near infrared spectroscopy equipment in medical literature. Not included within the scope of this document are: - invasive tissue or vascular oximeters; - oximeters that require a blood sample from the patient; - equipment measuring dissolved oxygen; - ME equipment, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71[4]; - ME equipment, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (SpO2). The requirements for pulse oximeter equipment are found in ISO 80601-2-61[3]; - ME equipment, or any part thereof, that claims to monitor tissue in parts of the body other than the head. This document also applies to cerebral tissue oximeter equipment, including cerebral tissue oximeter monitors, cerebral tissue oximeter probes and probe cable extenders, that have been remanufactured. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard. Túl hosszú scope

ICS

11.040.10 Altató-, érzéstelenítő-, lélegeztető- és újraélesztőberendezések

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2021-08-01

Forrás

idt EN ISO 80601-2-85:2021; idt ISO 80601-2-85:2021

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Utód

Módosítás

Kiegészítő információk

SZK-közlemények

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