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ILNAS-EN ISO 80601-2-12:2011 Edition 04/2011
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)
At present no electronic version for this standard online for following language version(s): DE.
Please feel free to contact normalisation@ilnas.etat.lu
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Abstract

ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. 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. ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6.

Status

Standard - Superseded

Origin

Technical Committee :
CEN/TC 215 : Respiratory and anaesthetic equipment

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project    23/07/2009   date of ratification (dor)    05/02/2011
end of the vote on the project    23/12/2009   date of anouncement (doa)    31/07/2011
start of the vote on the final project    04/11/2010   date of publication (dop)    31/10/2011
end of the vote on the final project    04/01/2011   date of withdrawal (dow)    15/04/2014


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/01/2012
Reference Mémorial A N° 2

Relations

Evolutions
ILNAS-EN ISO 80601-2-12:2020
ILNAS-EN ISO 80601-2-12:2011/AC:2011

Relations to older standards
ILNAS-EN 794-1:1997+A2:2009

Relations to international standards
ISO 80601-2-12 
ISO 80601-2-12 
IEC/CD 80601-2-12 
ISO 80601-2-12:2011 
ISO 80601-2-12:2011 

International Classification for Standards (ICS codes) :

11.040.10 : Anaesthetic, respiratory and reanimation equipment

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