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NEN-EN-ISO 80601-2-12

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

active, Most Current
Organization: NEN
Publication Date: 1 March 2020
Status: active
Page Count: 158
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
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 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.

[2] ISO 80601-2-13, Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

[3] ISO 80601-2-84:-2, Medical Electrical Equipment - Part 2-84: Particular requirements for basic safety and essential performance of emergency and transport ventilators

[4] ISO 10651-3, Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators

[5] ISO 80601-2-72:2015, Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

[6] ISO 80601-2-79:2018, Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

[7] ISO 80601-2-80:2018, Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

[9] ISO 80601-2-70, Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

[63] ISO 80601-2-87:-4, Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators

2 Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-84:2020.

4 Under preparation. Stage at the time of publication: ISO/DIS 80601-2-87:2020.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.

Document History

NEN-EN-ISO 80601-2-12
March 1, 2020
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
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...
October 1, 2011
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
A description is not available for this item.
May 1, 2011
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of...
August 1, 2009
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEC 60601-1:2005, Clause 1 applies, except as follows: Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of...

References

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