STN EN IEC 80601-2-71
| Označenie: | STN EN IEC 80601-2-71 |
| Platnosť: | Platná |
| Počet strán: | 64 |
| Jazyk: |
EN
|
| Listinná verzia: | 24,40€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
21,96€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 24,40€ c) S možnosťou tlače, prenosu textu a obrázkov: 31,72€ |
| Slovenský názov: | Zdravotnícke elektrické prístroje. Časť 2-71: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti prístrojov na funkčnú spektroskopiu v blízkej infračervenej oblasti (NIRS) |
| Anglický názov: | Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment |
| Dátum vydania: | 01. 05. 2025 |
| Dátum zrušenia: | |
| ICS: | 11.040.55 |
| Triediaci znak: | 36 4800 |
| Úroveň zapracovania: | idt EN IEC 80601-2-71:2025, idt IEC 80601-2-71:2025 |
| Vestník: | 04/25 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN IEC 80601-2-71:2018-11 (36 4800) |
| Poznámka vo Vestníku: | |
| Predmet normy: | IEC 80601-2-71:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT, as defined in 201.3.205, intended to be used by itself, or as a part of an ME SYSTEM hereinafter referred to as ME EQUIPMENT. 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1. This document is not applicable to – equipment for the measurement of oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules), i.e. tissue oximeters; – frequency-domain and time-domain equipment for functional near-infrared spectroscopy; – equipment for the measurement of changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin; – equipment for the measurement of changes in the concentration of oxy- and deoxy-haemoglobin in tissues ... |
| Náhľad normy: | Náhľad normy (PDF) |