{"id":625764,"date":"2024-11-06T00:05:37","date_gmt":"2024-11-06T00:05:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-80601-2-702020\/"},"modified":"2024-11-06T00:05:37","modified_gmt":"2024-11-06T00:05:37","slug":"iso-80601-2-702020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-80601-2-702020\/","title":{"rendered":"ISO 80601-2-70:2020"},"content":{"rendered":"

This document is applicable to the basic safety<\/i> and essential performance<\/i> of sleep apnoea breathing therapy equipment<\/i>, hereafter referred to as ME equipment, <\/i>intended to alleviate the symptoms of patients<\/i> who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient.<\/i> Sleep apnoea breathing therapy equipment<\/i> is intended for use in the home healthcare environment<\/i> by lay operators<\/i> as well as in professional healthcare institutions.<\/p>\n

* Sleep apnoea breathing therapy equipment<\/i> is not considered to utilize a physiologic closed-loop-control system<\/i> unless it uses a physiological patient<\/i> variable to adjust the therapy settings.<\/p>\n

This document excludes sleep apnoea breathing therapy equipment<\/i> intended for use with neonates.<\/p>\n

This document is applicable to ME equipment<\/i> or an ME system<\/i> intended for those patients<\/i> who are not dependent on mechanical ventilation. <\/p>\n

This document is not applicable to ME equipment<\/i> or an ME system<\/i> intended for those patients<\/i> who are dependent on mechanical ventilation such as patients<\/i> with central sleep apnoea. <\/p>\n

This document is also applicable to those accessories<\/i> intended by their manufacturer<\/i> to be connected to sleep apnoea breathing therapy equipment<\/i>, where the characteristics of those accessories<\/i> can affect the basic safety<\/i> or essential performance<\/i> of the sleep apnoea breathing therapy equipment<\/i>. <\/p>\n

Masks<\/i> and application accessories<\/i> intended for use during sleep apnoea breathing therapy <\/i>are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. <\/p>\n

If a clause or subclause is specifically intended to be applicable to ME equipment<\/i> only, or to ME systems<\/i> 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<\/i> and to ME systems<\/i>, as relevant.<\/p>\n

Hazards<\/i> inherent in the intended physiological function of ME equipment<\/i> or ME systems<\/i> 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 the general standard.<\/p>\n

NOTE See also 4.2 of the general standard.<\/p>\n

This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]<\/sup>.<\/p>\n

This document does not specify the requirements for ventilators or accessories<\/i> intended for critical care ventilators for ventilator-dependent patients,<\/i> which are given in ISO 80601-2-12.<\/p>\n

This document does not specify the requirements for ventilators or accessories<\/i> intended for anaesthetic applications, which are given in ISO 80601-2-13[8]<\/sup>.<\/p>\n

This document does not specify the requirements for ventilators or accessories<\/i> intended for home care ventilators for ventilator-dependent patients,<\/i> which are given in ISO 80601-2-72[9]<\/sup>.<\/p>\n

This document does not specify the requirements for ventilators or accessories<\/i> intended for emergency and transport, which are given in ISO 80601-2-84[12]<\/sup>.<\/p>\n

This document does not specify the requirements for ventilators or accessories<\/i> intended for home-care ventilatory support, which are given in ISO 80601-2-79[10]<\/sup> and ISO 80601-2-80[11]<\/sup>. <\/p>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment \u2014 Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy 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>\n2020-11<\/td>\n78<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":625778,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2634],"product_tag":[],"class_list":{"0":"post-625764","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\/625764","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\/625778"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=625764"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=625764"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=625764"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}