BS EN ISO 80601-2-61:2019
Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment
Medical electrical equipment - Particular requirements for basic safety and essential performance of pulse oximeter equipment
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 31 марта 2019 г.
- ICS:
- 11.040.10
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 80601-2-61:2019
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 <span style="fo...
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