BS EN ISO 80601-2-87:2021

This standard BS EN ISO 80601-2-87:2021 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

Clause 1 of IEC 60601‑1:2005+AMD1:2012+AMD2:2020 applies, except as follows:

NOTE The general standard is IEC 60601‑1:2005+AMD1:2012+AMD2:2020.

201.1.1 * Scope

Replacement:

This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) 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. High-frequency ventilators for this environment are considered life-sustaining.

  NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator).

  NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment.

• intended to be operated by a healthcare professional operator;

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

• capable of providing more than 150 inflations/min.

There are three principal designations of HFV:

• high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];

• high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and

• high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].

Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min.

* A high-frequency ventilator is not considered 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 an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator.

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 7.2.13 and 8.4.1 of IEC 60601‑1:2005.

NOTE 4 Additional information can be found in 4.2 of IEC 60601‑1:2005+AMD1:2012.

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:

• non-high-frequency ventilators or accessories which provide conventional ventilation for use in critical care environments, which are given in ISO 80601‑2‑12^[23];.

  NOTE 5 An HFV can incorporate conventional critical care ventilator operational modes, in which case ISO 80601‑2‑12 is applicable to those modes.

• ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13^[24];

• ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84, the replacement for ISO 10651‑3^[13];

  NOTE 6 An HFV can incorporate EMS ventilator capability.

• ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72^[26];

• ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601‑2‑79^[27] and ISO 80601‑2‑80^[28], the replacements for ISO 10651‑6^[15];

• sleep apnoea breathing therapy ME equipment, which are given in ISO 80601‑2‑70^[25];

• bi-level positive airway pressure (bi-level PAP) ME equipment;

• continuous positive airway pressure (CPAP) ME equipment;

• respiratory high-flow ME equipment, which are given in ISO 80601‑2‑90:—¹; and

• cuirass or “iron-lung” ventilation equipment.

This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.

201.1.2 Object

Replacement:

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

NOTE 1 Accessories are included because the combination of the high-frequency ventilator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a high-frequency ventilator.

NOTE 2 This document has been prepared to address the relevant essential principles^[39] and labelling^[40] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.

NOTE 3 This document has been prepared to address the relevant essential principles ofsafety and performance of ISO 16142‑1:2016 as indicated in Annex DD.

NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745^[38] as indicated in Annex FF.

201.1.3 Collateral standards

Amendment (add after existing text):

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

IEC 60601‑1‑2, IEC 60601‑1‑6 and IEC 60601‑1‑8 apply as modified in Clauses 202, 206 and 208 respectively. IEC 60601‑1‑3^[29], IEC 60601‑1‑9^[30], IEC 60601‑1‑11 and IEC 60601‑1‑12^[31] 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+AMD2:2020 or the collateral standards.

For brevity, IEC 60601‑1:2005+AMD1:2012+AMD2:2020 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 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 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 IEC 60601‑1:2005 or the applicable collateral standard.

“Amendment” means that the clause or subclause of IEC 60601‑1:2005 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, 203 for IEC 60601‑1‑3^[29], 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.