{"id":231259,"date":"2024-10-19T15:03:37","date_gmt":"2024-10-19T15:03:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-60601-2-662015\/"},"modified":"2024-10-25T09:22:13","modified_gmt":"2024-10-25T09:22:13","slug":"bs-en-60601-2-662015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-60601-2-662015\/","title":{"rendered":"BS EN 60601-2-66:2015"},"content":{"rendered":"

IEC 60601-2-66:2015 applies to the basic safety of hearing instruments and hearing instrument systems, hereafter also referred to as ME equipment or ME system. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this particular standard and to implement minor changes requested by interested parties.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
4<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
5<\/td>\nAnnex ZA (normative) Normative references to international publications with their corresponding European publications <\/td>\n<\/tr>\n
7<\/td>\nAnnex ZZ (informative) Coverage of Essential Requirements of EU Directives <\/td>\n<\/tr>\n
22<\/td>\nEnglish
CONTENTS <\/td>\n<\/tr>\n
23<\/td>\nFOREWORD <\/td>\n<\/tr>\n
25<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
26<\/td>\n201.1 Scope, object and related standards <\/td>\n<\/tr>\n
28<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
30<\/td>\n201.4 General requirements
201.5 General requirements for testing me equipment <\/td>\n<\/tr>\n
32<\/td>\n201.6 Classification of me equipment and me systems <\/td>\n<\/tr>\n
33<\/td>\n201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n
38<\/td>\n201.8 *Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n
40<\/td>\nFigure\u00a0201.101 \u2013 Measuring circuit for leakage current <\/td>\n<\/tr>\n
41<\/td>\n201.9 *Protection against mechanical hazards of me equipment and me systems
Table\u00a0201.102 \u2013 Mechanical hazards to be considered <\/td>\n<\/tr>\n
43<\/td>\n201.10 Protection against unwanted and excessive radiation hazards
201.11 *Protection against excessive temperatures and other hazards <\/td>\n<\/tr>\n
44<\/td>\n201.12 *Accuracy of controls and instruments and protection against hazardous outputs <\/td>\n<\/tr>\n
45<\/td>\n201.13 *Hazardous situations and fault conditions for me equipment <\/td>\n<\/tr>\n
48<\/td>\n201.14 *Programmable electrical medical systems (pems) <\/td>\n<\/tr>\n
49<\/td>\n201.15 *Construction of me equipment <\/td>\n<\/tr>\n
51<\/td>\n201.16 *Me systems
201.17 *Electromagnetic compatibility of me equipment and me systems <\/td>\n<\/tr>\n
52<\/td>\nAnnexes
Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current
Annex G (normative) Protection against hazards of ignition of flammable anaesthetic mixtures
Annex H (informative) Pems structure, pems development life-cycle and documentation
Annex I (informative) Me systems aspects
Annex J (informative) Survey of insulation paths <\/td>\n<\/tr>\n
53<\/td>\nAnnex K (informative) Simplified patient leakage current diagrams
Annex 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\u00a0AA.101 \u2013 Summary of the approach of this standard <\/td>\n<\/tr>\n
59<\/td>\nAnnex BB (informative) Abbreviations <\/td>\n<\/tr>\n
60<\/td>\nBibliography <\/td>\n<\/tr>\n
61<\/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 instruments and hearing instrument 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>\n2015<\/td>\n64<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":231263,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[270,2641],"product_tag":[],"class_list":{"0":"post-231259","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\/231259","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\/231263"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=231259"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=231259"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=231259"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}