{"id":625774,"date":"2024-11-06T00:05:40","date_gmt":"2024-11-06T00:05:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-80601-2-742021\/"},"modified":"2024-11-06T00:05:40","modified_gmt":"2024-11-06T00:05:40","slug":"iso-80601-2-742021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-80601-2-742021\/","title":{"rendered":"ISO 80601-2-74:2021"},"content":{"rendered":"

This document applies to the basic safety<\/em> and essential performance<\/em> of a humidifier<\/em>, also hereafter referred to as ME\u00a0equipment,<\/em> in combination with its accessories<\/em>, the combination also hereafter referred to as ME\u00a0system.<\/em><\/p>\n

This document is also applicable to those accessories<\/em> intended by their manufacturer<\/em> to be connected to a humidifier<\/em> where the characteristics of those accessories<\/em> can affect the basic safety<\/em> or essential performance<\/em> of the humidifier<\/em>.<\/p>\n

EXAMPLE\u00a01\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Heated breathing tubes<\/em> (heated-wire breathing tubes)<\/em> or ME\u00a0equipment<\/em> intended to control these heated breathing tubes<\/em> (heated breathing tube controllers<\/em>).<\/p>\n

NOTE\u00a01\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Heated breathing tubes<\/em> and their controllers are ME\u00a0equipment<\/em> and are subject to the requirements of IEC\u00a060601-1.<\/p>\n

NOTE\u00a02\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 ISO\u00a05367 specifies other safety and performance requirements for breathing tubes<\/em>.<\/p>\n

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 patients<\/em>.<\/p>\n

NOTE\u00a03\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 A humidifier<\/em> can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier<\/em>.<\/p>\n

EXAMPLE\u00a02\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Heated humidifier<\/em> incorporated into a critical care ventilator<\/em> where ISO\u00a080601-2-12[10]<\/sup> also applies.<\/p>\n

EXAMPLE\u00a03\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Heated humidifier<\/em> incorporated into a homecare ventilator<\/em> for dependent patients<\/em> where ISO\u00a080601-2-72[12]<\/sup> also applies.<\/p>\n

EXAMPLE\u00a04\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Heated humidifier<\/em> incorporated into sleep apnoea therapy equipment where ISO\u00a080601-2-70[11]<\/sup> also applies.<\/p>\n

EXAMPLE\u00a05\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Heated humidifier<\/em> incorporated into ventilatory support equipment where either ISO\u00a080601-2-79[13]<\/sup> or ISO\u00a080601-2-80[14]<\/sup> also apply.<\/p>\n

EXAMPLE\u00a06\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Heated humidifier<\/em> incorporated into respiratory high-flow therapy equipment where ISO\u00a080601-2-90[15]<\/sup> also applies.<\/p>\n

This document also includes requirements for an active\u00a0HME<\/em> (heat and moisture exchanger<\/em>), ME\u00a0equipment<\/em> which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME<\/em> to the patient<\/em>. This document is not applicable to a passive HME<\/em>, which returns a portion of the expired moisture and heat of the patient<\/em> to the respiratory tract during inspiration without adding heat or moisture.<\/p>\n

NOTE\u00a04\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 ISO\u00a09360-1 and ISO\u00a09360-2[4]<\/sup> specify safety and performance requirements for a passive HME<\/em>.<\/p>\n

NOTE\u00a05\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 If a clause or subclause is specifically intended to be applicable to ME\u00a0equipment<\/em> only, or to ME\u00a0systems<\/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 ME\u00a0equipment<\/em> and to ME\u00a0systems<\/em>, as relevant.<\/p>\n

Hazards<\/em> inherent in the intended physiological function of ME\u00a0equipment<\/em> or ME\u00a0systems<\/em> within the scope of this document are not covered by specific requirements in this document except in IEC\u00a060601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.<\/p>\n

NOTE\u00a06\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Additional information can be found in IEC\u00a060601-1:2005+AMD1:2012+AMD2:2020, 4.2.<\/p>\n

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\u00a020789[6]<\/sup>.<\/p>\n

This document is not applicable to equipment commonly referred to as \u201croom humidifiers\u201d or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers<\/em> incorporated into infant incubators.<\/p>\n

This document is not applicable to nebulizers used for the delivery of a drug to patients<\/em>.<\/p>\n

NOTE\u00a07\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 ISO\u00a027427[7]<\/sup> specifies the safety and performance requirements for nebulizers.<\/p>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment \u2014 Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2021-07<\/td>\n108<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":625788,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2634],"product_tag":[],"class_list":{"0":"post-625774","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/625774","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/625788"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=625774"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=625774"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=625774"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}