{"id":278105,"date":"2024-10-19T18:44:19","date_gmt":"2024-10-19T18:44:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-111972019\/"},"modified":"2024-10-25T15:16:17","modified_gmt":"2024-10-25T15:16:17","slug":"bs-en-iso-111972019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-111972019\/","title":{"rendered":"BS EN ISO 11197:2019"},"content":{"rendered":"

IEC 60601\u20111:2005+A1:2012, Clause 1 applies except as follows:<\/i><\/p>\n

201.1.1<\/b> Scope<\/p>\n

IEC 60601\u20111:2005+A1:2012, 1.1 is replaced by:<\/i><\/p>\n

This document applies to the basic safety<\/i> and essential performance<\/i> of medical supply units<\/i>, hereafter also referred to as ME equipment<\/i>.<\/p>\n

This document applies to medical supply units<\/i> manufactured within a factory or assembled on site, including cabinetry and other enclosures<\/i>, which incorporate patient<\/i>care services.<\/p>\n

\n

NOTE 1 A party that assembles on site various components intended for patient<\/i> care services into an enclosure<\/i> is considered the manufacturer<\/i> of the medical supply unit<\/i>.<\/p>\n<\/blockquote>\n

Hazards<\/i> inherent in the intended function of ME equipment<\/i> or ME systems<\/i> within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601\u20111:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).<\/p>\n

\n

NOTE 2 Refer to IEC 60601\u20111:2005+A1:2012, 4.2.<\/p>\n<\/blockquote>\n

201.1.2<\/b> Object<\/p>\n

IEC 60601\u20111:2005+A1:2012, 1.2 is replaced by:<\/i><\/p>\n

The object of this document is to establish particular basic safety<\/i> and essential performance<\/i> requirements for medical supply units<\/i> as defined in 201.3.201.<\/p>\n

201.1.3<\/b> Related standards<\/p>\n

201.1.3.1<\/b> General and Collateral standards<\/p>\n

IEC 60601\u20111:2005+A1:2012, 1.3 applies as the General Standard with the following addition:<\/i><\/p>\n

This particular standard refers to those applicable collateral standards that are listed in IEC 60601\u20111:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.<\/p>\n

IEC 60601\u20111\u20113:2008+A1:2013, IEC 60601\u20111\u20118:2006+A1:2012, IEC 60601\u20111\u20119:2007, IEC 60601\u20111\u201110:2007+A1:2013 and IEC 60601\u20111\u201111 and IEC 60601\u20111\u201112 do not apply.<\/p>\n

\n

NOTE Collateral standards are referred to by their document numbers.<\/p>\n<\/blockquote>\n

201.1.3.2<\/b> Particular standards<\/p>\n

IEC 60601\u20111:2005+A1:2012, 1.4 applies with the following additions:<\/i><\/p>\n

The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 60601\u20111:2005+A1:2012 with the prefix \u201c201\u201d (e.g. 201.1 in this standard addresses the content of IEC 60601\u20111:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix \u201c20x\u201d where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601\u20111\u20112 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601\u20111\u20113 collateral standard, etc.). The changes to the text of IEC 60601\u20111:2005+A1:2012 are specified by the use of the following words:<\/p>\n

    \n
  • \n

    \u201cReplacement\u201d means that the clause or subclause of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard is replaced completely by the text of this particular standard.<\/p>\n<\/li>\n

  • \n

    \u201cAddition\u201d means that the text of this particular standard is additional to the requirements of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard.<\/p>\n<\/li>\n

  • \n

    \u201cAmendment\u201d means that the clause or subclause of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard is amended as indicated by the text of this particular standard.<\/p>\n<\/li>\n<\/ul>\n

    Subclauses or figures which are additional to those of IEC 60601\u20111:2005+A1:2012 are numbered starting from 201.101. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.<\/p>\n

    Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where \u201cx\u201d is the number of the collateral standard, e.g. 202 for IEC 60601\u20111\u20112, 203 for IEC 60601\u20111\u20113, etc.<\/p>\n

    The term \u201cthis standard\u201d is used to make reference to IEC 60601\u20111:2005+A1:2012, any applicable collateral standards and this particular standard taken together.<\/p>\n

    Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.<\/p>\n

    IEC 60601\u20111:2005+A1:2012, Clause 1 applies except as follows:<\/i><\/p>\n

    201.1.1<\/b> Scope<\/p>\n

    IEC 60601\u20111:2005+A1:2012, 1.1 is replaced by:<\/i><\/p>\n

    This document applies to the basic safety<\/i> and essential performance<\/i> of medical supply units<\/i>, hereafter also referred to as ME equipment<\/i>.<\/p>\n

    This document applies to medical supply units<\/i> manufactured within a factory or assembled on site, including cabinetry and other enclosures<\/i>, which incorporate patient<\/i>care services.<\/p>\n

    \n

    NOTE 1 A party that assembles on site various components intended for patient<\/i> care services into an enclosure<\/i> is considered the manufacturer<\/i> of the medical supply unit<\/i>.<\/p>\n<\/blockquote>\n

    Hazards<\/i> inherent in the intended function of ME equipment<\/i> or ME systems<\/i> within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601\u20111:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).<\/p>\n

    \n

    NOTE 2 Refer to IEC 60601\u20111:2005+A1:2012, 4.2.<\/p>\n<\/blockquote>\n

    201.1.2<\/b> Object<\/p>\n

    IEC 60601\u20111:2005+A1:2012, 1.2 is replaced by:<\/i><\/p>\n

    The object of this document is to establish particular basic safety<\/i> and essential performance<\/i> requirements for medical supply units<\/i> as defined in 201.3.201.<\/p>\n

    201.1.3<\/b> Related standards<\/p>\n

    201.1.3.1<\/b> General and Collateral standards<\/p>\n

    IEC 60601\u20111:2005+A1:2012, 1.3 applies as the General Standard with the following addition:<\/i><\/p>\n

    This particular standard refers to those applicable collateral standards that are listed in IEC 60601\u20111:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.<\/p>\n

    IEC 60601\u20111\u20113:2008+A1:2013, IEC 60601\u20111\u20118:2006+A1:2012, IEC 60601\u20111\u20119:2007, IEC 60601\u20111\u201110:2007+A1:2013 and IEC 60601\u20111\u201111 and IEC 60601\u20111\u201112 do not apply.<\/p>\n

    \n

    NOTE Collateral standards are referred to by their document numbers.<\/p>\n<\/blockquote>\n

    201.1.3.2<\/b> Particular standards<\/p>\n

    IEC 60601\u20111:2005+A1:2012, 1.4 applies with the following additions:<\/i><\/p>\n

    The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 60601\u20111:2005+A1:2012 with the prefix \u201c201\u201d (e.g. 201.1 in this standard addresses the content of IEC 60601\u20111:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix \u201c20x\u201d where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601\u20111\u20112 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601\u20111\u20113 collateral standard, etc.). The changes to the text of IEC 60601\u20111:2005+A1:2012 are specified by the use of the following words:<\/p>\n

      \n
    • \n

      \u201cReplacement\u201d means that the clause or subclause of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard is replaced completely by the text of this particular standard.<\/p>\n<\/li>\n

    • \n

      \u201cAddition\u201d means that the text of this particular standard is additional to the requirements of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard.<\/p>\n<\/li>\n

    • \n

      \u201cAmendment\u201d means that the clause or subclause of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard is amended as indicated by the text of this particular standard.<\/p>\n<\/li>\n<\/ul>\n

      Subclauses or figures which are additional to those of IEC 60601\u20111:2005+A1:2012 are numbered starting from 201.101. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.<\/p>\n

      Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where \u201cx\u201d is the number of the collateral standard, e.g. 202 for IEC 60601\u20111\u20112, 203 for IEC 60601\u20111\u20113, etc.<\/p>\n

      The term \u201cthis standard\u201d is used to make reference to IEC 60601\u20111:2005+A1:2012, any applicable collateral standards and this particular standard taken together.<\/p>\n

      Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601\u20111:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.<\/p>\n

      PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\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>\nEuropean foreword
      Endorsement notice <\/td>\n<\/tr>\n
      9<\/td>\n201.1 Scope, object and related standards
      201.1.1 Scope
      201.1.2 Object
      201.1.3 Related standards
      201.1.3.1 General and Collateral standards <\/td>\n<\/tr>\n
      10<\/td>\n201.1.3.2 Particular standards
      201.2 Normative references <\/td>\n<\/tr>\n
      11<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
      13<\/td>\n201.4 General requirements
      201.5 General requirements for testing ME equipment
      201.6 Classification of ME equipment and ME systems <\/td>\n<\/tr>\n
      14<\/td>\n201.7 ME equipment identification, marking and documents <\/td>\n<\/tr>\n
      18<\/td>\n201.8 Protection against electrical hazards from ME equipment <\/td>\n<\/tr>\n
      25<\/td>\n201.9 Protection against mechanical hazards of ME equipment and ME systems <\/td>\n<\/tr>\n
      28<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
      201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n
      29<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs
      201.13 Hazardous situations and fault conditions
      201.13.2.2 Single fault conditions <\/td>\n<\/tr>\n
      30<\/td>\n201.14 Programmable electrical medical systems (PEMS)
      201.15 Construction of ME equipment <\/td>\n<\/tr>\n
      35<\/td>\n201.16 ME systems
      201.17 Electromagnetic compatibility of ME equipment and ME systems
      202 Medical electrical equipment \u2014 Parts 1-2 General requirements for basic safety and essential performance \u2014 Collateral standard: Electromagnetic disturbances \u2014 Requirements and tests
      206 Medical electrical equipment \u2014 Parts 1-6 General requirements for basic safety and essential performance \u2014 Collateral standard: Usability <\/td>\n<\/tr>\n
      36<\/td>\nAnnex A A (informative) Rationale <\/td>\n<\/tr>\n
      37<\/td>\nAnnex B B (informative) Tests during production <\/td>\n<\/tr>\n
      41<\/td>\nAnnex C C (informative) Documentation <\/td>\n<\/tr>\n
      42<\/td>\nAnnex D D (informative) Terminology \u2014 Alphabetical index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

      Medical supply units<\/b><\/p>\n\n\n\n\n
      Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
      BSI<\/b><\/a><\/td>\n2019<\/td>\n46<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278113,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-278105","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\/278105","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\/278113"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278105"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278105"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278105"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}