{"id":231470,"date":"2024-10-19T15:04:39","date_gmt":"2024-10-19T15:04:39","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iec-60601-2-662020\/"},"modified":"2024-10-25T09:24:27","modified_gmt":"2024-10-25T09:24:27","slug":"bs-en-iec-60601-2-662020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iec-60601-2-662020\/","title":{"rendered":"BS EN IEC 60601-2-66:2020"},"content":{"rendered":"

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV<\/span> which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision of the definition about ESSENTIAL PERFORMANCE; b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances;c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V; d) correction of the drop test level from 1,5 m to 1,0 m; e) correction of the wording of IEC 60601-2-66:2015.<\/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\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>\nAnnex ZZ(informative)Coverage of Essential Requirements of EU Directives <\/td>\n<\/tr>\n
13<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
15<\/td>\nFOREWORD <\/td>\n<\/tr>\n
18<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
19<\/td>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
21<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
22<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
23<\/td>\n201.4 General requirements <\/td>\n<\/tr>\n
24<\/td>\n201.5 General requirements for testing ME EQUIPMENT <\/td>\n<\/tr>\n
26<\/td>\n201.6 Classification of ME EQUIPMENT and ME SYSTEMS <\/td>\n<\/tr>\n
32<\/td>\n201.8 * Protection against electrical HAZARDS from ME EQUIPMENT <\/td>\n<\/tr>\n
33<\/td>\nFigure 201.101 \u2013 Measuring circuit for leakage current (see 201.8.7.4.7) <\/td>\n<\/tr>\n
34<\/td>\n201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS <\/td>\n<\/tr>\n
35<\/td>\nTable 201.101 \u2013 Mechanical hazards to be considered <\/td>\n<\/tr>\n
36<\/td>\n201.10 * Protection against unwanted and excessive radiation HAZARDS
201.11 * Protection against excessive temperatures and other HAZARDS <\/td>\n<\/tr>\n
38<\/td>\n201.12 * Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n
39<\/td>\n201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT <\/td>\n<\/tr>\n
41<\/td>\n201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) <\/td>\n<\/tr>\n
42<\/td>\n201.15 * Construction of ME EQUIPMENT <\/td>\n<\/tr>\n
44<\/td>\n201.16 * ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS <\/td>\n<\/tr>\n
46<\/td>\nAnnexes <\/td>\n<\/tr>\n
47<\/td>\nAnnex E (informative)Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current <\/td>\n<\/tr>\n
48<\/td>\nAnnex G (normative)Protection against hazards of ignition of flammableanaesthetic mixtures <\/td>\n<\/tr>\n
49<\/td>\nAnnex H (informative)Pems structure, pems development life-cycle and documentation <\/td>\n<\/tr>\n
50<\/td>\nAnnex I (informative)Me systems aspects <\/td>\n<\/tr>\n
51<\/td>\nAnnex J (informative)Survey of insulation paths <\/td>\n<\/tr>\n
52<\/td>\nAnnex K (informative)Simplified patient leakage current diagrams <\/td>\n<\/tr>\n
53<\/td>\nAnnex L (normative)Insulated winding wires for use without interleaved insulation <\/td>\n<\/tr>\n
54<\/td>\nAnnex AA (informative)Particular guidance and rationale <\/td>\n<\/tr>\n
55<\/td>\nTable AA.101 \u2013 Summary of the approach of this document <\/td>\n<\/tr>\n
59<\/td>\nAnnex BB (informative)Abbreviations <\/td>\n<\/tr>\n
60<\/td>\nAnnex CC (informative)Essential performance <\/td>\n<\/tr>\n
61<\/td>\nAnnex DD (informative)Electromagnetic compatibility of me equipment
Table DD.101 \u2013 Example of applicable standards for hearing aidspecific setting for RF radiated emissions <\/td>\n<\/tr>\n
62<\/td>\nTable DD.102 \u2013 Example of applicable tests <\/td>\n<\/tr>\n
63<\/td>\nBibliography <\/td>\n<\/tr>\n
65<\/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 hearing aids and hearing aid systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n68<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":231474,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[270,2641],"product_tag":[],"class_list":{"0":"post-231470","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-17-140-50","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\/231470","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\/231474"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=231470"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=231470"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=231470"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}