Standard ISO standard · ISO 80601-2-12:2020

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

Status: Valid

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Standard ISO standard · ISO 80601-2-12:2020

Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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Scope
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, t...

Subjects

Anaesthetic, respiratory and reanimation equipment (11.040.10)


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Standard ISO standard · ISO 80601-2-12:2020

Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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Price: 2 218 SEK
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Product information

Language: English

Written by: ISO

International title:

Article no: STD-80020452

Edition: 2

Approved: 2/25/2020

No of pages: 138

Replaces: ISO 80601-2-12:2011/Cor 1:2011 , ISO 80601-2-12:2011