This International Standard applies to the basic safety<\/small> and essential performance<\/small> of medical electrical equipment<\/small> and medical electrical systems<\/small> for use in the home healthcare environment<\/small>, as defined in 3.1, and specified by the manufacturer<\/small> in the instructions for use. This International Standard applies regardless of whether the me equipment<\/small> or me system<\/small> is intended for use by a lay operator<\/small> or by trained healthcare personnel.<\/p>\n
The home healthcare environment<\/small> includes:<\/p>\n the dwelling place in which a patient<\/small> lives;<\/p>\n<\/li>\n other places where patients<\/small> are present both indoors and outdoors, excluding professional healthcare facility environments where operators<\/small> with medical training are continually available when patients<\/small> are present.<\/p>\n<\/li>\n<\/ul>\n This International Standard does not apply to me equipment<\/small> and me systems<\/small> intended solely for use in the emergency medical services environment<\/small>, covered by IEC 60601\u20111\u201112 or solely for use in professional healthcare facilities covered by IEC 60601\u20111 without the additions of IEC 60601\u20111\u201112 or this collateral standard. Nonetheless, me equipment<\/small> or me systems<\/small> can be intended for multiple use environments, and as such, if also intended for use in the home healthcare environment<\/small>, are within the scope of this standard.<\/p>\n EXAMPLE<\/b> Me equipment<\/small> or me systems<\/small> intended for both the home healthcare environment<\/small> and the professional healthcare facility environment.<\/p>\n<\/blockquote>\n NOTE Home healthcare environment me equipment<\/small> and me systems<\/small> can frequently be used in locations with unreliable electrical sources and poor electrical grounding.<\/p>\n<\/blockquote>\n 1.2<\/b> Object<\/p>\n The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.<\/p>\n 1.3<\/b> Related standards<\/p>\n 1.3.1<\/b> IEC 60601\u20111<\/p>\n For me equipment<\/small> and me systems<\/small>, this collateral standard complements IEC 60601\u20111.<\/p>\n When referring to IEC 60601\u20111 or to this collateral standard, either individually or in combination, the following conventions are used:<\/p>\n “the general standard” designates IEC 60601\u20111 alone, including any amendments;<\/p>\n<\/li>\n “this collateral standard” designates IEC 60601\u20111\u201111 alone, including any amendments;<\/i><\/p>\n<\/li>\n “this standard” designates the combination of the general standard and this collateral standard.<\/p>\n<\/li>\n<\/ul>\n 1.3.2<\/b> Particular standards<\/p>\n A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.<\/p>\n Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment<\/b><\/p>\n\n
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\n PDF Pages<\/th>\n PDF Title<\/th>\n<\/tr>\n \n 2<\/td>\n undefined <\/td>\n<\/tr>\n \n 6<\/td>\n Blank Page <\/td>\n<\/tr>\n \n 8<\/td>\n Annex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n \n 10<\/td>\n Blank Page <\/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 2021<\/td>\n 72<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":418089,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[132,2641],"product_tag":[],"class_list":{"0":"post-418078","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-020-10","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\/418078","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\/418089"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=418078"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=418078"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=418078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}