BS EN ISO 80601-2-61:2026 - TC PDF

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

Название (английский):

BS EN ISO 80601-2-61:2026 - TC

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Дата публикации:: 30 июня 2026 г.
ICS:: 11.040.10
Технический комитет:: CEN
SKU:: BS EN ISO 80601-2-61:2026 - TC

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Abstract

201.1 Scope, object, and related standards IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 1 applies, except as follows:

201.1.1 Scope Replacement: NOTE 1 There is guidance or rationale for this subclause contained in AA.2.1. 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 apply to pulse oximeter equipment , including pulse oximeter monitors , pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products). The intended use of

BS EN ISO 80601-2-61:2026 - TC PDF

Abstract

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Abstract

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