STN EN ISO 80601-2-61
| Označenie: | STN EN ISO 80601-2-61 |
| Platnosť: | Platná |
| Počet strán: | 104 |
| Jazyk: |
EN
|
| Listinná verzia: | 31,80€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
28,62€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 31,80€ c) S možnosťou tlače, prenosu textu a obrázkov: 41,34€ |
| Slovenský názov: | Zdravotnícke elektrické prístroje. Časť 2-61: Osobitné požiadavky na základnú bezpečnosť a podstatné vlastnosti pulzových oxymetrov na zdravotnícke používanie (ISO 80601-2-61: 2017) |
| Anglický názov: | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2017) |
| Dátum vydania: | 01. 07. 2019 |
| Dátum zrušenia: | |
| ICS: | 11.040.10, 11.040.55 |
| Triediaci znak: | 85 2159 |
| Úroveň zapracovania: | idt EN ISO 80601-2-61:2019, idt ISO 80601-2-61:2017 |
| Vestník: | 06/19 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 80601-2-61:2011-08 (85 2159) |
| Poznámka vo Vestníku: | |
| Predmet normy: | ISO 80601-2-61:2017 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as me equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed. The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. ISO 80601-2-61:2017 is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. |
| Náhľad normy: | Náhľad normy (PDF) |