NF EN ISO 80601-2-74

<p>ISO 8185:2007 is a particular standard based on IEC 60601-1:1988 and its Amendments, Amd. 1:1991 and Amd. 2:1995.</p> <p>ISO 8185:2007 includes requirements for the basic safety and essential performance of humidification systems. It also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.</p> <p>NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1. </p> <p>ISO 8185:2007 also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. It is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance. </p> <p>Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, ISO 8185:2007 has been prepared as a particular standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. </p> <p>ISO 8185:2007 is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.</p> <p>ISO 8185:2007 is not applicable to nebulizers used for the delivery of drugs to patients.</p>

<p>This document applies to the <em>basic safety</em> and <em>essential performance</em> of a <em>humidifier</em>, also hereafter referred to as <em>ME equipment,</em> in combination with its <em>accessories</em>, the combination also hereafter referred to as <em>ME system.</em></p> <p>This document is also applicable to those <em>accessories</em> intended by their <em>manufacturer</em> to be connected to a <em>humidifier</em> where the characteristics of those <em>accessories</em> can affect the <em>basic safety</em> or <em>essential performance</em> of the <em>humidifier</em>.</p> <p>EXAMPLE 1         Heated <em>breathing tubes</em> (heated-wire <em>breathing tubes)</em> or <em>ME equipment</em> intended to control these heated <em>breathing tubes</em> (<em>heated breathing tube controllers</em>).</p> <p>NOTE 1        Heated <em>breathing tubes</em> and their controllers are <em>ME equipment</em> and are subject to the requirements of IEC 60601‑1.</p> <p>NOTE 2        ISO 5367 specifies other safety and performance requirements for <em>breathing tubes</em>.</p> <p>This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy <em>patients</em>.</p> <p>NOTE 3        A <em>humidifier</em> can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the <em>humidifier</em>.</p> <p>EXAMPLE 2         Heated <em>humidifier</em> incorporated into a critical care <em>ventilator</em> where ISO 80601‑2-12^[10] also applies.</p> <p>EXAMPLE 3         Heated <em>humidifier</em> incorporated into a homecare <em>ventilator</em> for dependent <em>patients</em> where ISO 80601‑2-72^[12] also applies.</p> <p>EXAMPLE 4         Heated <em>humidifier</em> incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70^[11] also applies.</p> <p>EXAMPLE 5         Heated <em>humidifier</em> incorporated into ventilatory support equipment where either ISO 80601-2-79^[13] or ISO 80601-2-80^[14] also apply.</p> <p>EXAMPLE 6         Heated <em>humidifier</em> incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90^[15] also applies.</p> <p>This document also includes requirements for an <em>active HME</em> (<em>heat and moisture exchanger</em>), <em>ME equipment</em> which actively adds heat and moisture to increase the humidity level of the gas delivered from the <em>HME</em> to the <em>patient</em>. This document is not applicable to a passive <em>HME</em>, which returns a portion of the expired moisture and heat of the <em>patient</em> to the respiratory tract during inspiration without adding heat or moisture.</p> <p>NOTE 4        ISO 9360‑1 and ISO 9360‑2^[4] specify safety and performance requirements for a passive <em>HME</em>.</p> <p>NOTE 5        If a clause or subclause is specifically intended to be applicable to <em>ME equipment</em> only, or to <em>ME systems</em> 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 <em>ME equipment</em> and to <em>ME systems</em>, as relevant.</p> <p><em>Hazards</em> inherent in the intended physiological function of <em>ME equipment</em> or <em>ME systems</em> within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.</p> <p>NOTE 6        Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.</p> <p>This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789^[6].</p> <p>This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or <em>humidifiers</em> incorporated into infant incubators.</p> <p>This document is not applicable to nebulizers used for the delivery of a drug to <em>patients</em>.</p> <p>NOTE 7              ISO 27427^[7] specifies the safety and performance requirements for nebulizers.</p>