Standards Development

Scope

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.Replacement:NOTE 1  There is guidance or rationale for this subclause contained in Clause AA.2.This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.261201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories:— intended for use with patients who can breathe spontaneously; and— intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation.EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance.Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.NOTE 2 In the home healthcare environment, the supply mains is often not reliable.Respiratory high-flow therapy equipment can be:— fully integrated ME equipment; or— a combination of separate items forming a ME system.This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.NOTE 3 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode.Respiratory high-flow therapy equipment can be transit-operable.This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment.EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway.NOTE 4 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment.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 the general standard, 7.2.13 and 8.4.1.NOTE 5 Additional information can be found in the general standard, 4.2.This document does not specify the requirements for:— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;— ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;— ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79;— ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80;— sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;— continuous positive airway pressure (CPAP) ME equipment;— high-frequency jet ventilators (HFJVs)[33], which are given in ISO 80601‑2‑87;— gas mixers for medical use, which are given in ISO 11195;— flowmeters, which are given in ISO 15002;— high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87; 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.Replacement:The object of this document is to establish particular basic safety and essential performance requirements for respiratory high-flow therapy equipment, as defined in 201.3.220, and its accessories.NOTE 1 Accessories are included because the combination of the respiratory high-flow therapy equipment and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of the respiratory high-flow therapy equipment.NOTE 2 This document has been prepared to address the relevant International Medical Device Regulators Forum (IMDRF) essential principles and labelling guidances as indicated in Annex CC.NOTE 34 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[28] .Amendment (add after existing text):This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this document.IEC 60601‑1‑2:2014+AMD1:2020+AMD2:2020, IEC 60601‑1‑6:2010+AMD1:2013+AMD2:2020, IEC 60601‑1‑8:2006+AMD1:2012+AMD2:2020 and IEC 60601‑1‑11:2015+AMD1:2020 apply as modified in Clauses 202, 206, 208 and 211 respectively. IEC 60601‑1‑3 and IEC 60601-1-9 does not apply. All other published collateral standards in the IEC 60601‑1 series apply as published.Replacement:In the IEC 60601 series, particular standards define basic safety and essential performance requirements, and may modify, replace or delete requirements contained in the general standard, including the collateral standards as appropriate for the particular ME equipment under consideration.A requirement of a particular standard takes priority over the general standard.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 that 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, 211.10 in this document addresses the content of Clause 10 of the IEC 60601‑1‑11 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 the general standard or 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 the general standard or applicable collateral standard."Amendment" means that the clause or subclause of the general standard or 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 3.154, 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, figures or tables which 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, 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 particular document, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.