BS EN ISO 80601-2-84:2020

This standard BS EN ISO 80601-2-84:2020 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

Clause 1 of the general standard applies, except as follows:

NOTE The general standard is IEC 60601‑1:2005+AMD1:2012.

201.1.1 * Scope

Replacement:

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:

• intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;

• intended to be operated by a healthcare professional operator;

• intended for use in the EMS environment; and

• intended for invasive or non-invasive ventilation.

NOTE 1 An EMS ventilator can also be used for transport within a professional healthcare facility.

* An EMS 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 the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.

NOTE 2 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 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2.

This document does not specify the requirements for the following:

• ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601‑2‑12.

• ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72^[3].

• ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13^[4].

• ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2‑79^[5] and ISO 80601‑2‑80^[6]1.

• obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70^[7].

• operator-powered resuscitators, which are given in ISO 10651‑4^[8].

• gas-powered emergency resuscitators, which are given in ISO 10651‑5^[9].

• continuous positive airway pressure (CPAP) ME equipment.

• high‐frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87^[11].

• high‐frequency oscillatory ventilators (HFOVs)^[10], which are given in ISO 80601‑2‑87^[11].

  NOTE 4 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.

• cuirass or “iron‐lung” ventilators.

201.1.2 Object

Replacement:

The object of this particular document is to establish basic safety and essential performance requirements for an EMS ventilator, as defined in 201.3.201, and its accessories.

Accessories are included because the combination of the EMS ventilator and the accessories needs to have acceptable risk. Accessories can have a significant impact on the basic safety or essential performance of an EMS ventilator.

NOTE 1 This document has been prepared to address the relevant essential principles ofsafety and performance of ISO 16142‑1:2016 as indicated in Annex CC.

NOTE 2 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745.

201.1.3 Collateral standards

Amendment (add at the end of the subclause):

This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and in 201.2 of this document.

IEC 60601‑1‑2, IEC 60601‑1‑6, IEC 60601‑1‑8 and IEC 60601‑1‑12 apply as modified in Clauses 202, 206, 208 and 212 respectively. IEC 60601‑1‑3^[12] and IEC 60601‑1‑11 do not apply. All other published collateral standards in the IEC 60601‑1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC 60601 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 IEC 60601‑1:2005+AMD1:2012 or the collateral standards.

For brevity, IEC 60601‑1:2005+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 particular document corresponds to those of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 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 Clause 4 of the IEC 60601‑1‑2 collateral standard, 208.4 in this document addresses the content of Clause 4 of the IEC 60601‑1‑8 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 IEC 60601‑1:2005+AMD1:2012 or the applicable collateral standard is replaced completely by the text of this particular document.

“Addition” means that the text of this document is additional to the requirements of IEC 60601‑1:2005+AMD1:2012 or the applicable collateral standard.

“Amendment” means that the clause or subclause of IEC 60601‑1:2005+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 IEC 60601‑1‑2, 208 for IEC 60601‑1‑8, 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 IEC 60601‑1:2005+AMD1:2012 or the applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601‑1:2005+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.