IEC 60601\u20111:2005+AMD1:2012, 1.1 is replaced by:<\/p>\n
This document specifies requirements for the basic safety<\/i> and essential performance<\/i> of an oxygen 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 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<\/blockquote>\n This document is applicable to a transit-operable<\/i> and non-transit-operable oxygen 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<\/b> An oxygen concentrator<\/i> with integrated oxygen conserving equipment<\/i> function or humidifier function.<\/p>\n<\/blockquote>\n EXAMPLE 2<\/b> An oxygen concentrator<\/i> used with a flowmeter stand.<\/p>\n<\/blockquote>\n EXAMPLE 3<\/b> 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<\/blockquote>\n EXAMPLE 4<\/b> An oxygen concentrator<\/i> with an integrated liquid reservoir function or gas cylinder filling system function.<\/p>\n<\/blockquote>\n This document is also applicable to those accessories<\/i> intended by their manufacturer<\/i> to be connected to an oxygen concentrator<\/i>, where the characteristics of those accessories<\/i> can affect the basic safety<\/i> or essential performance<\/i> of the oxygen 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<\/blockquote>\n This document does not specify requirements for oxygen 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<\/blockquote>\n Medical electrical equipment – Particular requirements for the basic safety and essential performance of oxygen concentrator equipment<\/b><\/p>\n\n
\n
\n
\n
\n
\n
\n
PDF Catalog<\/h4>\n
\n
\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n undefined <\/td>\n<\/tr>\n \n 5<\/td>\n European foreword
Endorsement notice <\/td>\n<\/tr>\n\n 7<\/td>\n C075946e.pdf <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" \n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2020<\/td>\n 76<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":361808,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-361801","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","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\/361801","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\/361808"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=361801"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=361801"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=361801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}