This document specifies requirements for the basic safety<\/i> and essential performance<\/i> of an oxygen<\/i> concentrator<\/i> in combination with its accessories<\/i>, hereafter referred to as ME equipment, <\/i>intended to increase the oxygen concentration of gas intended to be delivered to a single patient<\/i>. Such oxygen<\/i> concentrators<\/i> are typically intended for use in the home healthcare environment<\/i> by a single patient<\/i> in various environments including any private and public transportation as well as in commercial aircraft.<\/p>\n
NOTE 1 Such oxygen concentrators<\/i> can also be used in professional healthcare facilities.<\/i><\/p>\n
This document is applicable to a transit-operable <\/i>and non-transit-operable oxygen<\/i> concentrator.<\/i> This document is applicable to an oxygen concentrator<\/i> integrated into or used with other medical devices, ME equipment<\/i> or ME systems.<\/i><\/p>\n
EXAMPLE 1 An oxygen concentrator<\/i> with integrated oxygen conserving equipment<\/i> <\/sup> function or humidifier function.<\/p>\n EXAMPLE 2 An oxygen concentrator<\/i> used with a flowmeter stand.<\/p>\n EXAMPLE 3 An oxygen concentrator<\/i> as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]<\/sup>.<\/p>\n EXAMPLE 4 An oxygen concentrator<\/i> with an integrated liquid reservoir function or gas cylinder filling system function.<\/p>\n This document is also applicable to those accessories<\/i> intended by their manufacturer<\/i> to be connected to an oxygen<\/i> concentrator<\/i>, where the characteristics of those accessories<\/i> can affect the basic safety<\/i> or essential performance<\/i> of the oxygen<\/i> concentrator<\/i>. <\/p>\n NOTE 2 Such accessories<\/i> can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.<\/i><\/p>\n This document does not specify requirements for oxygen<\/i> concentrators <\/i>for use with a medical gas pipeline system<\/i>.<\/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 3 See also 4.2 of the general standard.<\/p>\n","protected":false},"excerpt":{"rendered":" Medical electrical equipment \u2014 Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment<\/b><\/p>\n\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n ISO<\/b><\/a><\/td>\n 2020-11<\/td>\n 72<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":625775,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2634],"product_tag":[],"class_list":{"0":"post-625762","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\/625762","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\/625775"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=625762"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=625762"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=625762"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}