Standard Swedish standard · SS-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)

Status: Valid

Buy this standard

Standard Swedish standard · SS-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)
Subscribe on standards - Read more Dölj
Price: 1 750 SEK
standard ikon pdf

PDF

Price: 1 750 SEK
standard ikon

Paper

Price: 2 800 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less
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, 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 a ...

Subjects

Anaesthetic, respiratory and reanimation equipment (11.040.10)


Buy this standard

Standard Swedish standard · SS-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)
Subscribe on standards - Read more Dölj
Price: 1 750 SEK
standard ikon pdf

PDF

Price: 1 750 SEK
standard ikon

Paper

Price: 2 800 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-80020686

Edition: 2

Approved: 3/17/2020

No of pages: 156

Replaces: SS-EN ISO 80601-2-12:2011/AC:2011 , SS-EN ISO 80601-2-12:2011