Path:
Home >
YY/T >
Page12 > YY/T 0868-2021
Price & Delivery
US$129.00 · In stock · Download in 9 secondsYY/T 0868-2021: Electrodes for nerve and muscle stimulators
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See
step-by-step procedureStatus: Valid
YY/T 0868: Historical versions
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| YY/T 0868-2021 | English | 129 |
Add to Cart
|
3 days [Need to translate]
|
Electrodes for nerve and muscle stimulators
|
| YY 0868-2011 | English | 399 |
Add to Cart
|
3 days [Need to translate]
|
Electrodes for nerve and muscle stimulators
|
Click to Preview a similar PDF
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 | 7,712 |
| 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.
...
