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YY/T 0994-2015 English PDF

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YY/T 0994-2015: Magnetic stimulation equipment
Status: Valid
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YY/T 0994-2015English169 Add to Cart 3 days [Need to translate] Magnetic stimulation equipment Valid YY/T 0994-2015

PDF similar to YY/T 0994-2015


Standard similar to YY/T 0994-2015

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Basic data

Standard ID YY/T 0994-2015 (YY/T0994-2015)
Description (Translated English) Magnetic stimulation equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 8,882
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Quoted Standard GB 9706.1-2007; GB/T 14710-2009; GB/T 16886.1-2011
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies) State Food and Drug Administration
Summary This Standard specifies the magnetic stimulation device of terms and definitions, requirements, test methods. 3.1 This Standard applies to the terms defined in the magnetic stimulation device (hereinafter referred to as the device). This Standard does not apply to the following devices: a permanent magnet-type device; rotating magnetic equipment; magnon heat treatment equipment.

YY/T 0994-2015: Magnetic stimulation equipment

---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.
Magnetic stimulation equipment ICS 11.040.60 C42 People's Republic of China pharmaceutical industry standards Magnetic stimulation device Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety," the content. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Chinese Academy of Medical Sciences Biological Institute of Biomedical Engineering. The main drafters of this standard. Wu Chi-wai, Chen Cheng, Jicai Yan, Wei Xu, Value of the Intensity Yin Tao. Magnetic stimulation device

1 Scope

This standard specifies the magnetic stimulation device terms and definitions, requirements, test methods. 3.1 This standard applies to the terms defined in the magnetic stimulation device (hereinafter referred to as the device). This standard does not apply to the following devices. --- Permanent magnet type of equipment; --- Gyromagnetic class equipment; --- Hot magnon therapy equipment.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB/T 14710-2009 medical electrical environmental requirements and test methods GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test

3 Terms and Definitions

GB 9706.1-2007 defined and the following terms and definitions apply to this document. 3.1 High-voltage energy storage capacitor utilizing the magnetic field coil spark device generating a pulse magnetic field cause irritation to the nervous system.

4 Requirements

4.1 Working conditions Unless the manufacturer otherwise specified, shall meet the requirements of Chapter 10 of GB 9706.1-2007. 4.2 magnetic induction Magnetic induction equipment shall meet the following requirements. a) the maximum magnetic flux density of not less than 1T. b) magnetic induction devices specified by the manufacturer, tolerance. ± 20%. 4.3 Output frequency The output frequency devices within 0Hz ~ 100Hz range, tolerance. ± 10%.

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