YY/T 0868-2021 English PDF

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YY/T 0868-2021: Electrodes for nerve and muscle stimulators
Status: Valid

YY/T 0868: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0868-2021	129	Add to Cart	3 days	Electrodes for nerve and muscle stimulators	Valid
YY 0868-2011	399	Add to Cart	3 days	Electrodes for nerve and muscle stimulators	Obsolete

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Basic data

Standard ID: YY/T 0868-2021 (YY/T0868-2021)
Description (Translated English): Electrodes for nerve and muscle stimulators
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C42
Word Count Estimation: 7,761
Issuing agency(ies): State Drug Administration

YY/T 0868-2021: Electrodes for 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.
Electrodes for nerve and muscle stimulators ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standards Replace YY/T 0868-2011 Electrodes for nerve and muscle stimulators Released on 2021-03-09 2023-05-01 implementation Issued by the National Medical Products Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0868-2011 "Electrodes for nerve and muscle stimulators", the main changes compared with YY/T 0868-2011 Change as follows. ---Modified the content of normative references (see Chapter 2, Chapter 2 of the.2011 edition); ---Modified terms and definitions (see 3.1, 3.1 in the.2011 edition); ---Modified the impedance requirements (see 4.2.1, 4.2.1 of the.2011 edition); ---The temperature requirement is deleted (see 4.2.2 of the.2011 edition); ---Added the requirements for the stickiness of the hydrogel sheet electrode (see 4.2.2.1); ---Added the requirements for the flexibility of the hydrogel sheet electrode (see 4.2.2.2); ---Modified the connection requirements (see 4.2.3, 4.2.3 of the.2011 edition); ---Added the requirements for the stability of the non-detachable electrode connection line (see 4.2.4); --- Deleted the requirements for the cross-sectional area of the electrode connection line (see 4.2.4 of the.2011 edition); ---The requirements for microorganisms have been added (see 4.2.7); ---Modified the biocompatibility (see 4.3, 4.3 in the.2011 edition); ---Modified the sterility test method (see 5.2.5, 5.2.5 of the.2011 edition). 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 standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) of the National Medical Electrical Appliance Standardization Technical Committee. Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Hunan Medical Device Inspection and Testing Institute, Omron (Dalian) Co., Ltd., Nanjing Dingshi Medical Equipment Co., Ltd. The main drafters of this standard. Li Yanan, Liu Bo, Zhang Yun, Deng Zhenjin, Zhang Weiqi, Deng Fei. The previous versions of the standard replaced by this standard are as follows. ---YY/T 0868-2011. Electrodes for nerve and muscle stimulators

1 Scope

This standard specifies the terms, definitions, requirements, and test methods for electrodes for nerve and muscle stimulators (hereinafter referred to as electrodes). This standard applies to electrodes for nerve and muscle stimulators. This standard does not apply to electro-acupuncture, fili-needle, and electrodes that only contain acupoint detection function in Chinese medicine.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 3280-2015 stainless steel cold-rolled steel plate and strip GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance GB/T 14233.1-2008 Medical transfusion, blood transfusion, injection equipment inspection methods Part 1.Chemical analysis methods GB 15979-2002 Hygienic standard for disposable sanitary products GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management YY 9706.210-2021 Medical electrical equipment Part 2-10.Basic safety and basic performance of nerve and muscle stimulators Use requirements "The Pharmacopoeia of the People's Republic of China".2015 Edition Four

3 Terms and definitions

The following terms and definitions defined in YY 9706.210-2021 apply to this document. 3.1 The electrical stimulation signal output by the stimulator is transmitted to the human body through conductive materials (such as rubber, hydrogel, metal, etc.), which conforms to Accessories for neuromuscular stimulator equipment specified in YY 9706.210-2021 (the electrode connection line is also considered to be a part of the electrode).

4 requirements

4.1 Dimensions The size of the conductive part of the electrode and the size of the electrode connecting wire are specified by the manufacturer, and the error should not exceed ±5% of the nominal value. 4.2 Performance 4.2.1 Impedance The manufacturer should declare the conductive impedance range and test frequency of each specification electrode in the random file, and the impedance measurement value should be declared by the manufacturer In the range. ......

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