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ABNT ISO TS 22002-5:2020
Norma Técnica
Código
ISO 80601-2-61:2011   CANCELADA
Data de Publicação : 16/03/2011
Título : Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Título Idioma Sec. : Appareils électromédicaux — Partie 2-61: Exigences particulières pour la sécurité de base et les performances essentielles pour les oxymètres de pouls
Comitê : ISO/TC 121 Anaesthetic and respiratory equipment
Páginas : 86
Status : Cancelada em 15/12/2017  Substituída por : ISO 80601-2-61:2017
Idioma : Inglês
Motivo do Cancelamento :
Organismo : ISO - International Organization for Standardization
Objetivo : ISO 80601-2-61:2011 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. ISO 80601-2-61:2011 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. ISO 80601-2-61:2011 can also be applied to pulse oximeter equipment and their accessories used for compensation or alleviation of disease, injury or disability. ISO 80601-2-61:2011 is not applicable to pulse oximeter equipment intended solely for foetal use. ISO 80601-2-61:2011 is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the patient environment.
Normas Necessárias para a aplicação da ISO 80601-2-61:2011
IEC 80601-2-30:2009
IEC 80601-2-30:2009/Amd 1:2013
IEC 80601-2-35:2009
IEC 80601-2-58:2008
IEC 80601-2-59:2008
IEC 80601-2-60:2012
ISO 80601-2-12:2011
ISO 80601-2-12:2011 Cor 1:2011
ISO 80601-2-13:2011
ISO 80601-2-55:2011
ISO 80601-2-56:2009
ISO 80601-2-61:2011
Normas Substitutas da ISO 80601-2-61:2011
ISO 80601-2-61:2017
ICS/CIN
11.040.10 - Equipamento de anestesia, de respiração e de reanimação
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