{"id":279831,"date":"2024-10-19T18:53:38","date_gmt":"2024-10-19T18:53:38","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-60601-1-122015a12020\/"},"modified":"2024-10-25T15:28:13","modified_gmt":"2024-10-25T15:28:13","slug":"bs-en-60601-1-122015a12020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-60601-1-122015a12020\/","title":{"rendered":"BS EN 60601-1-12:2015+A1:2020"},"content":{"rendered":"

This International Standard applies to the basic safety<\/small> and essential performance<\/small> of medical electrical equipment<\/small> and medical electrical systems<\/small>, hereafter referred to as me equipment<\/small> and me systems<\/small>, which are intended, as indicated in the instructions for use by their manufacturer<\/small>, for use in the ems environment<\/small> (emergency medical services environment<\/small>), as defined in 3.1.<\/p>\n

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NOTE 1 For the purposes of this standard, the intent of the manufacturer<\/small> is indicated in the instructions for use. The responsible organization<\/small> and the operator<\/small> need to be aware that any other use outside the manufacturer\u2019s<\/small> intended use<\/small> can result in a hazardous situation<\/small> for the patient<\/small>.<\/p>\n<\/blockquote>\n

The ems environment<\/small> includes<\/p>\n

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  • \n

    responding to and providing life support at the scene of an emergency to a patient<\/small> reported as experiencing injury or illness in a pre-hospital setting, and transporting the patient<\/small>, while continuing such life support care, to an appropriate professional healthcare facility for further care.<\/p>\n<\/li>\n

  • \n

    providing monitoring, treatment or diagnosis during transport between professional healthcare facilities.<\/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 home healthcare environment<\/small> covered by IEC 60601\u20111\u201111 or solely for use in professional healthcare facilities covered by IEC 60601\u20111 without the additions of IEC 60601\u20111\u201111 or this collateral standard. me equipment<\/small> and me systems<\/small> are often not solely intended for one environment. Such me equipment<\/small> or me system<\/small> can be intended for multiple use environments, and as such, if also intended for use in the ems environment<\/small>, are within the scope of this standard.<\/p>\n

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    EXAMPLE<\/p>\n

    Me equipment<\/small> or me system<\/small> intended for both the ems environment<\/small> and the professional healthcare facility environment.<\/p>\n<\/blockquote>\n

    \n

    NOTE 2 Ems environment me equipment<\/small> and me systems<\/small> can be used in locations with unreliable electrical sources and outdoor environmental conditions.<\/p>\n<\/blockquote>\n

    1.2<\/b> * Object<\/p>\n

    The object of this collateral standard is to provide general requirements for me equipment<\/small> and me systems<\/small> carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions.<\/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

    <\/b>For me equipment<\/small> and me systems<\/small>, this collateral standard complements IEC 60601\u20111.<\/b><\/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

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    • \n

      “the general standard” designates IEC 60601\u20111 alone, <\/b>including any amendments<\/b>;<\/p>\n<\/li>\n

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      “this collateral standard” designates IEC 60601\u20111\u201112 alone, <\/b>including any amendments<\/b>;<\/p>\n<\/li>\n

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      “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

      PDF Catalog<\/h4>\n\n\n\n\n\n\n\n
      PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
      2<\/td>\nundefined <\/td>\n<\/tr>\n
      4<\/td>\nBlank Page <\/td>\n<\/tr>\n
      6<\/td>\nAnnex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n
      8<\/td>\nBlank Page <\/td>\n<\/tr>\n
      9<\/td>\nBlank Page <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

      Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment<\/b><\/p>\n\n\n\n\n
      Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
      BSI<\/b><\/a><\/td>\n2020<\/td>\n58<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279837,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-279831","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","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\/279831","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\/279837"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279831"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279831"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279831"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}