BS EN ISO 80601-2-80:2019
Medical electrical equipment - Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
Medical electrical equipment - Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 ноября 2019 г.
- ICS:
- 11.040.10
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 80601-2-80:2019
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 ventilatory support equipment , as defined in 201.3.205, for ventilatory insufficiency , as defined in 201.3.204, hereafter also referred to as me equipment , in combination with its accessories :
— intended for use in the home healthcare environment ;
— intended for use by a lay operator ;
— intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
— intended for <spa...
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