Back

EVS-EN ISO 80601-2-12:2020

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)

General information
Valid from 02.04.2020
Base Documents
ISO 80601-2-12:2020; EN ISO 80601-2-12:2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
02.04.2020
Main
02.11.2011
Main
02.11.2011
Corrigendum
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. - intended to be operated by a healthcare professional operator; and - intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1. NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13 [2]; - ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84 [3], the future replacement for ISO 10651-3 [4]; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2-72 [5]; - ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 [6] and ISO 80601-2-80 [7], the replacements for ISO 10651-6 [8]; - sleep apnoea therapy me equipment, which are given in ISO 80601-2-70 [9]; - continuous positive airway pressure (CPAP) me equipment; - high-frequency jet ventilators (HFJVs); - high-frequency oscillatory ventilators (HFOVs) [10]; - oxygen therapy constant flow me equipment; - cuirass or “iron-lung” ventilation equipment. This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.
*
*
*
PDF
30.04 € incl tax
Paper
30.04 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

EVS-EN IEC 80601-2-49:2019

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
Newest version Valid from 01.11.2019
Main + amendment

EVS-EN 60529:2001+A2:2014

Degrees of protection provided by enclosures (IP code) (IEC 60529:1989 + IEC 60529:1989/A1:1999 + IEC 60529:1989/A2:2013)
Newest version Valid from 01.04.2014
Main

EVS-EN ISO 15001:2011

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
Newest version Valid from 02.11.2011
Main

ISO 10651-3:1997

Lung ventilators for medical use -- Part 3: Particular requirements for emergency and transport ventilators
Newest version Valid from 22.01.1997