{"id":386687,"date":"2024-10-20T03:36:35","date_gmt":"2024-10-20T03:36:35","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-80601-2-262020-2\/"},"modified":"2024-10-26T06:35:35","modified_gmt":"2024-10-26T06:35:35","slug":"bs-en-iec-80601-2-262020-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-80601-2-262020-2\/","title":{"rendered":"BS EN IEC 80601-2-26:2020"},"content":{"rendered":"

IEC 80601-2-26:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: \u2013 phono-photic stimulators; \u2013 EEG data storage and retrieval; \u2013 ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document. IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.<\/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\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
5<\/td>\nAnnex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n
7<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
8<\/td>\nFOREWORD <\/td>\n<\/tr>\n
11<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
12<\/td>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
14<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n201.4 General requirements <\/td>\n<\/tr>\n
16<\/td>\n201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
Tables
Table 201.101 \u2013 Distributed essential performance requirements <\/td>\n<\/tr>\n
17<\/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
20<\/td>\nFigures
Figure 201.101 \u2013 Test of protection against the effectsof defibrillation (common mode) <\/td>\n<\/tr>\n
22<\/td>\nFigure 201.102 \u2013 Test of protection against the effectsof defibrillation (differential mode) <\/td>\n<\/tr>\n
23<\/td>\n201.9 Protection against mechanical hazards of me equipment and me systems
Figure 201.103 \u2013 Application of the test voltage between lead wiresto test the energy delivered by the defibrillator <\/td>\n<\/tr>\n
24<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n
25<\/td>\n201.12 Accuracy of controls and instruments and protection against hazardous outputs
Table 201.102 \u2013 Input voltage ranges and rates of variation <\/td>\n<\/tr>\n
26<\/td>\nFigure 201.104 \u2013 General test circuit <\/td>\n<\/tr>\n
28<\/td>\nFigure 201.105 \u2013 Test circuit for noise and common mode rejection(see 201.12.1.104 and 201.12.1.106) <\/td>\n<\/tr>\n
29<\/td>\n201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic disturbances \u2013 Requirements and tests <\/td>\n<\/tr>\n
30<\/td>\nFigure 202.101 \u2013 Test layout for radiated and conducted emission testand radiated immunity test(see 202.4.3.1) <\/td>\n<\/tr>\n
32<\/td>\nFigure 202.102 \u2013Test circuit for hf surgical equipment protection measurementaccording to 202.8.101 <\/td>\n<\/tr>\n
33<\/td>\n206 Usability
Figure 202.103 \u2013 Test setup for hf surgical equipment measurementaccording to 202.8.101 <\/td>\n<\/tr>\n
34<\/td>\nAnnexes <\/td>\n<\/tr>\n
35<\/td>\nAnnex AA (informative)Particular guidance and rationale <\/td>\n<\/tr>\n
38<\/td>\nBibliography <\/td>\n<\/tr>\n
39<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for the basic safety and essential performance of electroencephalographs<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":386695,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[146,2641],"product_tag":[],"class_list":{"0":"post-386687","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-99","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\/386687","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\/386695"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=386687"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=386687"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=386687"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}