{"id":625781,"date":"2024-11-06T00:05:42","date_gmt":"2024-11-06T00:05:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-80601-2-852021\/"},"modified":"2024-11-06T00:05:42","modified_gmt":"2024-11-06T00:05:42","slug":"iso-80601-2-852021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-80601-2-852021\/","title":{"rendered":"ISO 80601-2-85:2021"},"content":{"rendered":"<p>This document applies to <i>basic safety<\/i> and <i>essential performance <\/i>of <i>cerebral tissue oximeter equipment<\/i>, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the <i>probe<\/i> attached to the head. The <i>cerebral tissue oximeter equipment<\/i> can be based on continuous light, frequency domain or time domain technologies. This document applies to <i>ME equipment<\/i> used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to <i>ME equipment<\/i> for those environments of use.<\/p>\n<p>NOTE 1  <i>Cerebral tissue oximeters<\/i> are sometimes referred to as near infrared spectroscopy equipment in medical literature.<\/p>\n<p>Not included within the scope of this document are:<\/p>\n<ul>\n<li>      invasive tissue or vascular oximeters; <\/li>\n<li>      oximeters that require a blood sample from the <i>patient<\/i>;<\/li>\n<li>      equipment measuring dissolved oxygen;<\/li>\n<li> <i>ME equipment<\/i>, or part thereof, that measures path-length-dependent haemoglobin change. The requirements for functional near-infrared spectroscopy equipment are found in ISO 80601-2-71<sup>[4]<\/sup>;<\/li>\n<li> <i>ME equipment<\/i>, or part thereof, that measures arterial saturation based on pulsatile changes in tissue optical properties (<i>SpO<sub>2<\/sub><\/i>). The requirements for pulse oximeter equipment are found in ISO 80601-2-61<sup>[3]<\/sup>;<\/li>\n<li> <i>ME equipment<\/i>, or any part thereof, that claims to monitor tissue in parts of the body other than the head.<\/li>\n<\/ul>\n<p>This document also applies to <i>cerebral tissue oximeter equipment<\/i>, including <i>cerebral tissue oximeter monitors<\/i>, <i>cerebral tissue oximeter probes<\/i> and <i>probe cable extenders<\/i>, that have been <i>remanufactured<\/i>.<\/p>\n<p>If a clause or subclause is specifically intended to be applicable to <i>ME equipment<\/i> only, or to <i>ME systems<\/i> 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 <i>ME equipment<\/i> and to <i>ME systems<\/i>, as relevant.<\/p>\n<p><i>Hazards<\/i> inherent in the intended physiological function of <i>ME equipment<\/i> or <i>ME systems<\/i> within the scope of this document are not covered by specific requirements in this document except in 201.11 and in 201.7.2.13 and 201.8.4.1 of the general standard.<\/p>\n<p>NOTE 2  See also 4.2 of the general standard. <\/p>\n<p>This document can also be applied to <i>ME equipment<\/i> and their <i>accessories<\/i> used for compensation or alleviation of disease, injury or disability.<\/p>\n<p>This document is not applicable to remote or slave (secondary) equipment that displays <i>StO<\/i><sub><i>2<\/i><\/sub> values that are located outside of the <i>patient environment<\/i>.<\/p>\n<p>NOTE 3<i>  ME equipment<\/i> that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function. <\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical electrical equipment \u2014 Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2021-03<\/td>\n<td>116<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":625793,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2634],"product_tag":[],"class_list":{"0":"post-625781","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-iso","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\/625781","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\/625793"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=625781"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=625781"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=625781"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}