{"id":380781,"date":"2024-10-20T03:08:27","date_gmt":"2024-10-20T03:08:27","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-60601-1-102008a22021\/"},"modified":"2024-10-26T05:41:13","modified_gmt":"2024-10-26T05:41:13","slug":"bs-en-60601-1-102008a22021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-60601-1-102008a22021\/","title":{"rendered":"BS EN 60601-1-10:2008+A2:2021"},"content":{"rendered":"

1.1<\/b> * Scope<\/p>\n

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>.<\/p>\n

This collateral standard specifies requirements for the development (analysis, design, verification<\/small> and validation<\/small>) of a physiologic closed<\/small>–loop controller<\/small> (pclc<\/small>) as part of a physiologic closed<\/small>–loop control system<\/small> (pclcs<\/small>) to control at least one patient variable<\/small> (i.e. a physiologic variable<\/small>) in me equipment<\/small> and me systems<\/small>.<\/p>\n

\n

EXAMPLE A patient variable<\/small> can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a physical property (e.g. body temperature, electrophysiologic characteristic, hemodynamic quantity), or a pharmaceutical concentration.<\/p>\n<\/blockquote>\n

This collateral standard applies to various types of pclc<\/small>, e.g. linear and non-linear, adaptive, fuzzy, neural networks.<\/p>\n

This collateral standard does not specify:<\/p>\n

    \n
  • \n

    additional mechanical requirements; or<\/p>\n<\/li>\n

  • \n

    additional electrical requirements.<\/p>\n<\/li>\n<\/ul>\n

    This collateral standard applies to a closed-loop controller (see Figure 1) that sets the controller output variable<\/small> in order to adjust (i.e., change or maintain) the measured physiologic variable<\/small> by relating it to the reference variable<\/small>.<\/p>\n

    A closed-loop controller that maintains a physical or chemical variable<\/small>, using feedback that is not measured from a patient<\/small>, is outside the scope of this standard.<\/p>\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

      \n
    • \n

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

    • \n

      “this collateral standard” designates IEC 60601\u20111\u201110 alone, including any amendments;<\/p>\n<\/li>\n

    • \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","protected":false},"excerpt":{"rendered":"

      Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers<\/b><\/p>\n\n\n\n\n
      Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
      BSI<\/b><\/a><\/td>\n2021<\/td>\n52<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":380790,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-380781","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\/380781","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\/380790"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=380781"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=380781"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=380781"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}