YY 9706.246-2023 English PDFUS$469.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 9706.246-2023: Requirements for service certification of rural homestay inn Status: Valid
Basic dataStandard ID: YY 9706.246-2023 (YY9706.246-2023)Description (Translated English): Requirements for service certification of rural homestay inn Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: A00 Classification of International Standard: 11.040.99 Word Count Estimation: 22,215 Date of Issue: 2023-01-13 Date of Implementation: 2026-01-15 Issuing agency(ies): State Drug Administration Summary: This standard specifies the safety requirements for operating tables. Whether or not such operating tables have electrical components, including transmissions. This transmission device is used for the transmission of the table top of the operating table with a detachable table top relative to the bottom (or base) of the operating table. This standard does not apply to patient dental chairs, examination chairs and couches, patient support systems for diagnostic and therapeutic equipment, heating blankets for operating tables, patient transfer equipment, delivery tables and beds, medical beds, field operating tables. If the operating table is to be used in combination with diagnostic/therapeutic equipment, the relevant specific standard requirements for diagnostic and/or therapeutic equipment apply. YY 9706.246-2023: Requirements for service certification of rural homestay inn---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.ICS 11.040.99 CCSC46 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0570-2013 Medical electrical equipment - Part 2-46.Operating tables Particular requirements for basic safety and essential performance (IEC 60601-2-46.2016, MOD) Released on 2023-01-13 2026-01-15 Implementation Released by the State Drug Administration table of contentsPreface III Introduction IV 201.1 Scope, purpose and related criteria1 201.2 Normative references 2 201.3 Terms and Definitions 2 201.4 General requirements 3 201.5 General requirements for operating table tests 3 201.6 Classification of operating tables and ME systems3 201.7 Operating table marking, marking and documentation4 201.8 Protection of operating tables against electric shock hazards4 201.9 Protection against mechanical hazards of operating tables and ME systems 4 201.10 Protection against unnecessary or excessive radiation hazards6 201.11 Protection against extreme temperatures and other hazards6 201.12 Accuracy of controls and instruments and protection against hazardous outputs7 201.13 Hazardous situations and fault conditions for operating tables 7 201.14 Programmable electrical medical systems (PEMS) 7 201.15 Construction of operating tables7 201.16 ME system 8 201.17 Electromagnetic compatibility of operating tables and ME systems8 202 Electromagnetic Disturbance - Requirements and Tests 8 202.6 Electromagnetic compatibility of operating tables and ME systems 8 203 Diagnostic X-ray Equipment Radiation Protection 10 Appendix G (Normative) Protection against ignition hazards of flammable anesthetic mixtures 12 Appendix AA (Informative) Special Guidelines and Principles 13 Reference 15 index 16 Figure 202.101 Enclosure specific test 9 Figure 202.102 Specific tests for supply flexible cords 9 Figure 202.103 Accessory cable specific test 10 Figure AA.1 Recommended distribution of body weight over 135kg and application examples 13 Table.201.101 Determination of tensile safety factor 6 Table AA.1 recommended distribution of body weight over 135kg and application examples 13forewordThe "Medical Electrical Equipment" series of standards are divided into two parts. --- Part 1.General and parallel requirements; --- Part 2.Special requirements. This document is part 2-46. This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" drafting. This document replaces YY 0570-2013 "Medical Electrical Equipment Part 2.Special Requirements for Operating Table Safety". This document is consistent with YY 0570- Compared with.2013, the main technical changes are as follows. ---Renumber the clauses of this document according to the clause numbers of GB 9706.1-2020; --- Added basic performance requirements (see.201.4.3); ---Modified some test methods (see.201.9, 202, Chapter 4, Article 36 of the.2013 edition). This document is modified to adopt IEC 60601-2-46.2016 "Medical Electrical Equipment Part 2-46.Basic Safety and Essential Performance of Operating Tables Special Requirements". The technical differences between this document and IEC 60601-2-46.2016 and their reasons are as follows. --- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to my country's technical conditions and adjustments Centrally reflected in.201.2 "Normative Reference Documents", the specific adjustments are as follows. ● Replace IEC 60601-1.2012 with GB 9706.1-2020, which adopts international standards; ● Replace IEC 60601-1-3.2008 AMD1.2013 with GB 9706.103-2020, which adopts the revised international standard; ● Replace IEC 60601-1-2.2007 with YY 9706.102-2021, which is equivalent to the international standard; ● Replace IEC 60601-2-2 with GB 9706.202, which adopts international standards; ● Replace IEC 60601-2-43 with GB 9706.243 which adopts international standard. ---When a series of standards and different versions of the same standard are involved in the document, the series of standards with corresponding relations have not been transformed in China or the relevant version of the standard was not converted. Therefore, in order to maintain the meaning consistent with the original text, the International Standard number is retained. Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying these patents. This document is proposed by the State Drug Administration. This document is sponsored by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) Focus on. This document is drafted by. Nanjing Mindray Biomedical Electronics Co., Ltd., Shanghai Medical Device Inspection and Research Institute. The main drafters of this document. Cen Jian, Xu Chao, Tao Hua, Zhang Jinmiao, Chen Yuzhong. The previous versions of the documents replaced by this document are as follows. ---YY 0570-2005, YY 0570-2013.IntroductionSafety standards for medical electrical equipment, also known as the 9706 series of standards, are proposed to be composed of general standards, collateral standards, specific standards, guidelines and interpretations constitute. ---General standard. The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements. --- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special It is only the equipment that needs to meet the requirements of such standards. ---Special standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards standard. ---Guidelines and interpretations. explanations for the application guidelines and clauses of the relevant requirements in the standards involved. This document deals with the basic safety and essential performance of operating tables. This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1.General requirements for basic safety and essential performance", hereinafter referred to as general standards. The requirements of this document take precedence over those of the general standard. An asterisk (*) used as the first character of a title or the beginning of a paragraph or table title in this document indicates that there is a relevant item in Appendix AA. Project-specific guidelines and rationale. The relevant content of Appendix AA is not only helpful to the correct use of this document, but also when used in clinical practice. After changes or technological developments, the process of revising standards can be accelerated in a timely manner. However, Appendix AA is not part of the requirements of this document. Medical electrical equipment - Part 2-46.Operating tables Particular requirements for basic safety and essential performance 201.1 Scope, purpose and relevant standards Clause 1 of the general standard 1) applies except as follows. 1) The general standard refers to GB 9706.1-2020. 201.1.1 Scope replace. This document specifies the safety requirements for operating tables. Regardless of whether such an operating table has electrical components, including transmissions. this transmission The device is used for the transmission of the table top of the operating table with a detachable table top relative to the bottom (or base) of the operating table. Note. See 4.2 of the general standard. This document does not apply to. ---patient dental chair; --- Check chairs and sofas; ---Patient support system for diagnostic and therapeutic equipment (see GB 9706.243); --- Operating table heating blanket (see YY 9706.235); ---Patient transfer equipment; ---conveyor table and bed; ---Medical bed (see YY 9706.252); --- Field operating table. If the operating table will be used in combination with diagnostic/therapeutic equipment, the relevant specific standard requirements for diagnostic and/or therapeutic equipment are applicable. 201.1.2 Purpose replace. The purpose of this document is to develop specific requirements for the basic safety and essential performance of operating tables as defined in.201.3.201. 201.1.3 Collateral Standards Supplement. This document refers to Chapter 2 of the General Standard as well as applicable collateral standards listed in Chapter.201.2 of this document. YY 9706.102 and GB 9706.103 apply after the modification of Chapter 202 and Chapter 203 respectively. YY 9706.108, YY/T 9706.110, YY 9706.111 and YY 9706.112 do not apply. All other published collateral standards in the 9706 series apply. 201.1.4 Particular standards replace. In the 9706 series of standards, specific standards may modify, replace or delete the requirements contained in general standards or collateral standards to apply to the For ME EQUIPMENT considered, other basic safety and essential performance requirements may also be added. The requirements of a particular standard take precedence over the general standard. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.246-2023_English be delivered?Answer: Upon your order, we will start to translate YY 9706.246-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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