{"id":512550,"date":"2024-11-05T14:19:19","date_gmt":"2024-11-05T14:19:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/can-csa-c22-2-no-80601-2-7117\/"},"modified":"2024-11-05T14:19:19","modified_gmt":"2024-11-05T14:19:19","slug":"can-csa-c22-2-no-80601-2-7117","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/csa\/can-csa-c22-2-no-80601-2-7117\/","title":{"rendered":"CAN\/CSA-C22.2 NO. 80601-2-71:17"},"content":{"rendered":"

Preface<\/strong><\/p>\n

This is the first edition of CAN\/CSA-C22.2 No. 80601-2-71, Medical electrical equipment \u2014 Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-71 (first edition, 2015-06). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. At the time of publication, IEC 80601-2-71:2015 is available from IEC in English only. CSA Group will publish the French version when it becomes available from IEC.<\/p>\n

For brevity, this Standard will be referred to as CAN\/CSA-C22.2 No. 80601-2-71 throughout.<\/p>\n

This Standard is intended to be used in conjunction with CAN\/CSA-C22.2 No. 60601-1:14, Medical electrical equipment \u2014 Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).<\/p>\n

Scope and object<\/strong><\/p>\n

Clause 1 of the general standard1 applies, except as follows:<\/p>\n

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

Replacement:
This International standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT.<\/p>\n

Not included within the scope of this particular standard are:<\/p>\n

a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules);
b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output;
c) pulse oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61.
d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy, which may require different test procedures than defined herein.
e) FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin, which may require different tes procedures than defined herein.<\/p>\n

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

Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for FUNCTIONAL NIRS EQUIPMENT as defined in 201.3.205.<\/p>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment \u2014 Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
CSA<\/b><\/a><\/td>\n2017-07-01<\/td>\n53<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":512561,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[143,2674],"product_tag":[],"class_list":{"0":"post-512550","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-55","7":"product_cat-csa","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\/512550","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\/512561"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=512550"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=512550"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=512550"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}