BS EN ISO 80601-2-61:2019 PDF

Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment

First page of standard BS EN ISO 80601-2-61:2019

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Title (English):

BS EN ISO 80601-2-61:2019

Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment

Document status:: Withdrawn
Format:: Electronic (PDF)
Publication date:: March 31, 2019
ICS:: 11.040.10
Technical committee:: CEN
SKU:: BS EN ISO 80601-2-61:2019

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Abstract

201.1 Scope, object and related standards IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows:

201.1.1 * Scope Replacement: This document 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

Related standards

Mentioned in the description and other BS standards

201.1 Scope, object and related standards IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows:

BS EN ISO 80601-2-61:2019 PDF

Abstract

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Abstract

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