{"id":631013,"date":"2024-11-06T00:31:27","date_gmt":"2024-11-06T00:31:27","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-99192005\/"},"modified":"2024-11-06T00:31:27","modified_gmt":"2024-11-06T00:31:27","slug":"iso-99192005","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-99192005\/","title":{"rendered":"ISO 9919:2005"},"content":{"rendered":"

For the purposes of ISO 9919:2005, the Scope given in IEC 60601-1:1988 (Clause 1) applies, except as follows.<\/p>\n

Amendment (add at the end of 1.1):<\/i><\/p>\n

ISO 9919:2005 specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment <\/b>intended <\/b>for use on humans. This includes any part necessary for normal use<\/b>, e.g. the pulse oximeter monitor<\/b>, pulse oximeter probe<\/b>, probe cable extender<\/b>.<\/p>\n

These requirements also apply to pulse oximeter equipment,<\/b> including pulse oximeter monitors<\/b>, pulse oximeter probes<\/b> and probe cable extenders,<\/b> that has been reprocessed<\/b>. <\/p>\n

The intended use of pulse oximeter equipment<\/b> includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate on patients<\/b> in healthcare institutions as well as on patients<\/b> in home care. <\/p>\n

ISO 9919:2005 is not applicable to pulse oximeter equipment<\/b> intended for use in laboratory research applications nor to oximeters that requires a blood sample from the patient<\/b>.<\/p>\n

ISO 9919:2005 is not applicable to pulse oximeter equipment<\/b> solely intended for fetal use.<\/p>\n

ISO 9919:2005 is not applicable to remote or slave (secondary) devices that display SpO<\/b>2<\/sub> values that are located outside of the patient environment<\/b>.<\/p>\n

The requirements of ISO 9919:2005 which replace or modify requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.<\/p>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment \u2014 Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ISO<\/b><\/a><\/td>\n2005-03<\/td>\n92<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":631025,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2634],"product_tag":[],"class_list":{"0":"post-631013","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\/631013","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\/631025"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=631013"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=631013"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=631013"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}