ISO 80601-2-12:2020 Withdrawn
Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators
Abstract
- 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 80601‑2-72:2015[5];
- ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1];
- obstructive 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) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[63];
NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes.
- oxygen therapy constant flow ME equipment; and
- cuirass or "iron-lung" ventilation equipment.
[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.
Additional information
Publication type | International Standard |
---|---|
Publication date | 2020-02-25 |
Withdrawal date | 2023-11-03 |
Edition | 2.0 |
Available language(s) | English, French |
TC/SC | TC 62/SC 62D - Particular medical equipment, software, and systemsrss |
ICS | 11.040.10 - Anaesthetic, respiratory and reanimation equipment |
Stability date | 2023 |
Pages | 138 |
File size | 3142 KB |
The following test report forms are related:
More information
Share this page
Share your publications
Learn how to share your publications with your colleagues, using networking options.
Payment information
Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa, JCB and CUP), PayPal and bank transfers as form of payment.
Keep in touch
Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.
Contact customer services
Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 16:00 CET Monday to Friday.