BS EN ISO 80601-2-12:2020

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;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.

Clause1 of the general standard applies, except as follows:

NOTE The general standard is IEC60601-1:2005+AMD1:2012.

201.1.1 *Scope

Replacement:

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;

  NOTE1 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.

  NOTE2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

  NOTE3 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.

NOTE4 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 IEC60601-1:2005, 7.2.13 and 8.4.1.

NOTE5 Additional information can be found in IEC60601-1:2005+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.

NOTE6 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 ISO80601-2-13^[2];

• ventilators or accessories intended for the emergency medical services environment, which are given in ISO80601-2-84^[3], the future replacement for ISO10651-3^[4];

• ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO80601-2-72:2015^[5];

• ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO80601-2-79:2018^[6] and ISO80601-2-80:2018^[7]1;

• obstructive sleep apnoea therapy ME equipment, which are given in ISO80601-2-70^[9];

• continuous positive airway pressure (CPAP) ME equipment;

• high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO80601-2-87^[63];

  NOTE7 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.

201.1.2 Object

Replacement:

The object of this document is to establish basic safety and essential performance requirements for a ventilator and its accessories.

Accessories are included because the combination of the ventilator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a ventilator.

NOTE1 This document has been prepared to address the relevant essential principles ofsafety and performance of ISO16142-1:2016 as indicated in AnnexCC.

NOTE2 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745as indicated in AnnexDD.

201.1.3 Collateral standards

Amendment (add after existing text):

This document refers to those applicable collateral standards that are listed in Clause2 of the general standard and in 201.2 of this document.

IEC60601-1-2, IEC60601-1-6 and IEC60601-1-8 apply as modified in Clauses202, 206 and 208 respectively. IEC60601-1-3^[12], IEC60601-1-9^[13], IEC60601-1-11 and IEC60601-1-12 do not apply. All other published collateral standards in the IEC60601-1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC60601 series, particular standards may modify, replace or delete requirements contained in the general standard, including the collateral standards, as appropriate for the particular ME equipment under consideration, and may add other basic safety or essential performance requirements.

A requirement of a particular standard takes priority over IEC60601-1:2005 or the collateral standards.

For brevity, IEC60601-1:2005+AMD1:2012 is referred to in this particular document as the general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to those of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause1 of the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause4 of the IEC60601-1-2 collateral standard, 208.4 in this document addresses the content of Clause4 of the IEC60601-1-8 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:

“Replacement” means that the clause or subclause of IEC60601-1:2005+AMD1:2012 or the applicable collateral standard is replaced completely by the text of this document.

“Addition” means that the text of this document is additional to the requirements of IEC60601-1:2005+AMD1:2012 or the applicable collateral standard.

“Amendment” means that the clause or subclause of IEC60601-1:2005+AMD1:2012 or the applicable collateral standard is amended as indicated by the text of this document.

Subclauses, figures or tables that are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses or figures that are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC60601-1-2, 203 for IEC60601-1-3^[12], etc.

The term “this document” is used to make reference to the general standard, any applicable collateral standards and this particular document taken together.

Where there is no corresponding clause or subclause in this document, the clause or subclause of IEC60601-1:2005+AMD1:2012 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC60601-1:2005+AMD1:2012 or the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular document.