BS EN ISO 80601-2-84:2023
Medical electrical equipment - Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
Medical electrical equipment - Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 ноября 2023 г.
- ICS:
- 11.040.10
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 80601-2-84:2023
Abstract
201.1 Scope, object and related standards
[IEC 60601‑1:2005](/catalog/IEC%2060601-1%3A2005)+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 Clause AA.2.
This document applies to the basic safety and
essential performance of an EMS
ventilator in combination with its
accessories , hereafter also referred to as
ME equipment:
— intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients ;
— intended to be operated by a healthcare professional operator ;
— intended for use in the EMS environment ; and
— intended for invasive or non-invasive <span clas...
Похожие стандарты
Упомянутые в описании и другие стандарты BS
IEC 60601-1:2005
ДействующийMedical electrical equipment - Part 1: General requirements for basic safety and essential performance
Overview IEC 60601-1:2005 (Consolidated Edition 3.1, with Amendment 1) is the international safety standard for medical electrical equipment, defining the general requirements for basic safety and es…
BS ISO 10835:2007
ДействующийDirect reduced iron and hot briquetted iron. Sampling and sample preparation.
1 Scope This International Standard gives a) the underlying theory, b) the basic principles for sampling and preparation of samples , and c) the basic requirements for the design, installation and op…