{"id":282231,"date":"2024-10-19T19:04:41","date_gmt":"2024-10-19T19:04:41","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-60601-2-502009a12016\/"},"modified":"2024-10-25T15:46:45","modified_gmt":"2024-10-25T15:46:45","slug":"bs-en-60601-2-502009a12016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-60601-2-502009a12016\/","title":{"rendered":"BS EN 60601-2-50:2009+A1:2016"},"content":{"rendered":"

Replacement<\/i>:<\/p>\n

This International Standard applies to the basic safety<\/span> and essential performance<\/span> of infant phototherapy equipment<\/span>, as defined in 201.3.203<\/span> of this standard, also referred to as me equipment<\/span>.<\/p>\n

If a clause or subclause is specifically intended to be applicable to me equipment<\/span> only, or to me systems<\/span> 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<\/span> and to me systems<\/span>, as relevant.<\/p>\n

H azards<\/span> inherent in the intended physiological function of me equipment<\/span> or me systems<\/span> within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.<\/p>\n

\n
\n NOTE\n <\/div>\n

See also 4.2 of the general standard.<\/p>\n<\/div>\n

This particular standard specifies safety requirements for infant phototherapy equipment<\/span>, but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer<\/span> has demonstrated in his risk management file<\/span> that the risk<\/span> presented by the hazard<\/span> has been found to be of an acceptable level when weighed against the benefit of treatment from the device.<\/p>\n

This particular standard does not apply to:<\/p>\n

    \n
  • \n

    devices supplying heat via blankets<\/span>, pads<\/span> or mattresses<\/span> in medical use, for information see IEC 80601\u20112\u201135<\/span> <\/span>;<\/p>\n<\/li>\n

  • \n

    infant incubators<\/span>; for information see IEC 60601\u20112\u201119<\/span> <\/span>;<\/p>\n<\/li>\n

  • \n

    infant transport incubators<\/span>; for information, see IEC 60601\u20112\u201120<\/span> <\/span>;<\/p>\n<\/li>\n

  • \n

    infant radiant warmers<\/span>; for information see IEC 60601\u20112\u201121<\/span> <\/span>.<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

    Medical electrical equipment – Particular requirements for the basic safety and essential performance of infant phototherapy equipment<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    BSI<\/b><\/a><\/td>\n2017<\/td>\n36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":282234,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[144,2641],"product_tag":[],"class_list":{"0":"post-282231","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-60","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\/282231","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\/282234"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=282231"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=282231"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=282231"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}