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YY 9706.257-2021: Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY 9706.257-2021: Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY9706.257-2021 YY PHARMACEUTICAL INDUSTRY STANDARD ICS 01.040.01 C 40 Medical electrical equipment - Part 2-57.Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (IEC 60601-2-57.2011, MOD) Issued on. MARCH 09, 2021 Implemented on. MAY 01, 2023 Issued by. National Medical Products Administration Table of ContentsForeword... 3 201.1 Scope, object and related standards... 5 201.2 Normative references... 7 201.3 Terms and definitions... 8 201.4 General requirements... 12 201.5 General requirements for testing ME EQUIPMENT... 12 201.6 Classification of ME EQUIPMENT and ME SYSTEMS... 12 201.7 ME EQUIPMENT identification, marking and documents... 16 201.8 Protection against electrical HAZARDS from ME EQUIPMENT... 20 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS... 21 201.10 Protection against unwanted and excessive radiation HAZARDS... 21 201.11 Protection against excessive temperatures and other HAZARDS... 23 201.12 Accuracy of controls and instruments and protection against hazardous outputs ... 23 201.13 HAZARDOUS SITUATIONS and fault conditions... 25 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)... 25 201.15 Construction of ME EQUIPMENT... 25 201.16 ME SYSTEMS... 25 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS... 25 Annexes... 26 Annex AA (informative) Particular guidance and rationale... 27 Annex BB (informative) Exposure limit Values... 30 Annex CC (informative) Protective eyewear for LS EQUIPMENT... 34 Annex DD (informative) Summary of MANUFACTURER’S requirements... 35 Annex EE (informative) Symbols on marking... 37 Bibliography... 39ForewordThis Part is mandatory for the full text. “Medical electrical equipment” is divided into two parts. - Part 1.General requirements for the basic safety and essential performance; - Part 2.Particular requirements for the basic safety and essential performance. This Part is “Medical electrical equipment - Part 2-57.Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use”. This Part was drafted in accordance with the rules given in GB/T 1.1-2009. This Part adopts the redrafting method to amend IEC 60601-2-57.2011 “Medical electrical equipment - Part 2-57.Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use”. There are technical differences between this Part and IEC 60601-2-57.2011, and the clauses involved in these differences have been marked by a vertical single line (|) in the position of the outer margin. The technical differences between this Part and IEC 60601-2-57.2011 and their reasons are as follows. - Regarding normative references, this Part has made adjustments with technical differences to adapt to the technical conditions of China. The adjustments are concentrated in “201.2 Normative references”, and the specific adjustments are as follows. • REPLACE ISO 3864-2 with GB/T 2893.2, which is amended form the international standard; • REPLACE IEC 62471 with GB/T 20145, which is identical to the international standards; • REPLACE IEC 60947-3 with GB/T 14048.3, which is identical to the international standard. For ease of use, for IEC 60601-2-57.2011, this Part has made the following editorial changes. - DELETE the note in 201.3 about the index of terms and definitions; - AMEND 202.102 in 201.6.1.102.2 b) TO 201.102, which is an editorial error. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Part was proposed by the National Medical Products Administration. This Part shall be under the jurisdiction of Sub-Technical Committee on Medical Optics and Instrument of Standardization Administration of China (SAC/TC 103/SC 1). Drafting organization of this Part. Zhejiang Institute of Medical Device Testing. Main drafters of this Part. Ye Yueshun, Li Min, Du Kun, Fang Chunzi. Medical electrical equipment - Part 2-57.Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use 201.1 Scope, object and related standards Clause 1 of the general standard applies, except as follows. 201.2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 201.3 Terms and definitions For the purposes of this document, the terms and definitions given in GB 9706.1, apply, except as follows. Replacement. 201.4 General requirements Clause 4 of the general standard applies. 201.5 General requirements for testing ME EQUIPMENT Clause 5 of the general standard applies. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies, except as follows. 201.7 ME EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows. 201.8 Protection against electrical HAZARDS from ME EQUIPMENT Clause 8 of the general standard applies, except as follows. 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies. 201.10 Protection against unwanted and excessive radiation HAZARDS Clause 10 of the general standard applies except as follows. 201.11 Protection against excessive temperatures and other HAZARDS Clause 11 of the general standard applies. 201.12 Accuracy of controls and instruments and protection against hazardous outputs Clause 12 of the general standard applies, except as follows. 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) Clause 14 of the general standard applies. 201.15 Construction of ME EQUIPMENT Clause 15 of the general standard applies. 201.16 ME SYSTEMS Clause 16 of the general standard applies. 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS Clause 17 of the general standard applies. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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