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YY 9706.210-2021 English PDF

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US$259.00 · In stock
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YY 9706.210-2021: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 9706.210-2021	259	Add to Cart	3 days	Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators	Valid

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Basic data

Standard ID: YY 9706.210-2021 (YY9706.210-2021)
Description (Translated English): Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C42
Word Count Estimation: 14,186
Issuing agency(ies): State Drug Administration

YY 9706.210-2021: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

---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.
Medical electrical equipment - Part 2-10.Particular requirements for the basic safety and essential performance of nerve and muscle stimulators ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standards Replace YY 0607-2007 Medical Electrical Equipment Part 2-10.Nerves and Muscles Specific requirements for basic safety and basic performance of stimulators (IEC 60601-2-10.2012 AMD1.2016CSV,MOD) Released on 2021-03-09 2023-05-01 implementation Issued by the National Medical Products Administration

Foreword Ⅰ 201.1 Scope, purpose and related standards 1 201.2 Normative references 2 201.3 Terms and Definitions 2 201.4 General requirements 3 201.5 General requirements for ME equipment testing 3 201.6 Classification of ME equipment and ME systems 3 201.7 ME equipment identification, marking and documentation 4 201.8 Protection of ME equipment against electric shock hazard 5 201.9 Protection of ME equipment and ME system against mechanical hazards 5 201.10 Protection against unwanted and excessive radiation risks 5 201.11 Protection against over-temperature and other hazards 5 201.12 Accuracy of controllers and instruments and protection of dangerous outputs 5 201.13 Hazardous Situations and Failure Conditions of ME Equipment 7 201.14 Programmable Medical Electrical System (PEMS) 7 201.15 Structure of ME equipment 7 201.16 ME System 7 201.17 Electromagnetic compatibility of ME equipment and ME systems 7 202 Electromagnetic compatibility---requirements and tests 7 Appendix 8 Appendix C (informative appendix) Guidelines for marking and labeling requirements for ME equipment and ME systems 9 Appendix AA (informative appendix) Special guidance and principle explanation 10

Foreword

All technical content of this part is mandatory. The "Medical Electrical Equipment" series of standards is divided into two parts. ---Part 1.General and parallel requirements; ---Part 2.Special requirements. This part is part 2-10. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces YY 0607-2007 "Medical Electrical Equipment Part 2.Special Requirements for the Safety of Nerve and Muscle Stimulators", and Compared with YY 0607-2007, the main technical changes except for editorial changes are as follows. ---Modified the scope of application of the standard (see.201.1.1, 1.1 of YY 0607-2007); ---Added some terms and definitions (see.201.3.201,.201.3.202); ---Added the requirements of the risk management process (see.201.4.2.); ---Modified the output requirements [see.201.7.2.101, 6.1p of YY 0607-2007]; ---Modified the requirements of the instruction manual (see.201.7.9.2, 6.8.2 of YY 0607-2007); ---Modified the requirements for the accuracy of controllers and instruments (see.201.12.1, Chapter 50 of YY 0607-2007); ---Modified the requirements of output blocking (see.201.12.4.102, 51.102 of YY 0607-2007); ---Modified the requirements of electromagnetic compatibility (see 202, Chapter 36 of YY 0607-2007); --- The requirements for continuous leakage current, patient auxiliary current and dielectric strength have been deleted (see Chapter 19 and Chapter 20 of YY 0607-2007 chapter). This part uses the redrafting law to amend and adopt IEC 60601-2-10.2012 AMD1.2016 CSV "Medical Electrical Equipment No. 2- Part 10.Specific requirements for basic safety and basic performance of nerve and muscle stimulators. The technical differences between this part and IEC 60601-2-10.2012 AMD1.2016CSV and the reasons are as follows. ---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments. The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows. ● Replace IEC 60601-1 with GB 9706.1 modified to adopt international standards; ● Replace IEC 60601-1-2 with YY 9706.102 modified to adopt international standards. This section has made the following editorial changes. ---Deleted some non-required notes; --- Deleted the index of terms and definitions in IEC 60601-2.10.2012 AMD1.2016CSV. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Medical Electrical Appliance Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4). Drafting organizations of this section. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Daosheng Medical Technology Co., Ltd., Henan Xiangyu Medical Equipment Co., Ltd. The main drafters of this section. Duan Qiaofeng, Gaoshan, Zhou Huilin, Zhang Yun, Liu Bo, Qian Xuebo, Li Fei, Yang Guojuan. The previous releases of the standards replaced by this part are as follows. ---YY 0607-2007; ---YY 0016-1993; ---YY 91093-1994. Medical Electrical Equipment Part 2-10.Nerves and Muscles Specific requirements for basic safety and basic performance of stimulators 201.1 Scope, purpose and related standards In addition to the following, Chapter 1 of the general standard applies. 201.1.1 Scope replace. This section specifies the safety requirements for nerve and muscle stimulators (hereinafter referred to as ME equipment) used in the practice of physical medicine. Contains the classics Skin electric nerve stimulator and electric muscle stimulator. Note 1.Muscle stimulators can also be considered neuromuscular stimulators. Note 2.In the "special guide and principle description" part of the more important requirements have been annotated, see Appendix AA. This section does not apply to the following ME equipment. ---ME equipment used for implantation or connected to implanted electrodes; ---ME equipment used for brain stimulation (such as electroconvulsive ME equipment); ---ME equipment used for neurological research; ---External cardiac pacemaker (see YY 0945.2); ---ME equipment used for induced response diagnosis (see YY 9706.240); ---ME equipment used for electromyography (see YY 9706.240); --- Cardiac defibrillation ME equipment (see GB 9706.8). 201.1.2 Purpose replace. The purpose of this section is to establish specific requirements for the basic safety and basic performance of the nerve and muscle stimulators defined in.201.3.204. 201.1.3 Parallel standards supplement. This section refers to Chapter 2 of the General Standards and applicable parallel standards listed in.201.2 of this section. YY 9706.102 was revised and cited in 202.GB 9706.103 is not quoted. 201.1.4 Specific standards replace. The specific standards can modify, replace or delete the requirements contained in the general standards or parallel standards to apply to the ME equipment under consideration. Other basic safety and basic performance requirements can be added. The requirements in the specific standards take precedence over the general standards. In this section, GB 9706.1 is referred to as the general standard. Parallel standards are indicated by their standard numbers. The numbering of the chapters and articles in this part corresponds to the general standard by adding the prefix "201" (for example,.201.1 in this part corresponds to Chapter 1 of the general standard). Chapter content), or by adding the prefix "20x" to correspond to the applicable collateral standard, where x is the end of the international standard number corresponding to the collateral standard Digits (for example, 202.4 in this part corresponds to the content of Chapter 4 in IEC 60601-1-2 corresponding to the parallel standard YY 9706.102, this part ......

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Question 1: How long will the true-PDF of YY 9706.210-2021_English be delivered?

Answer: Upon your order, we will start to translate YY 9706.210-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 9706.210-2021_English with my colleagues?

Answer: Yes. The purchased PDF of YY 9706.210-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.