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YY 0951-2015: Interferential current therapy instrument
Status: Obsolete YY 0951: Evolution and historical versions
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Interferential current therapy instrument
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Basic data | Standard ID | YY 0951-2015 (YY0951-2015) | | Description (Translated English) | Interferential current therapy instrument | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 13,176 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2017-01-01 | | Quoted Standard | GB/T 191-2008; GB 9706.1-2007; GB/T 14710-2009; GB/T 16886.1; YY/T 0466.1-2009; YY 0505; YY 0607-2007; YY 0868-2011 | | Adopted Standard | YY 0607-2007, MOD | | 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 interference therapy equipment terminology and definitions, classification, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. 3.1 This Standard applies to equipment regulations. | YY 0951-2015: Interferential current therapy instrument---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.
Interferential current therapy instrument
ICS 11.040.60
C42
People's Republic of China pharmaceutical industry standards
Interference therapy equipment
Issued on. 2015-03-02
2017-01-01 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.
This revised standard adopts YY 0607-2007 "Medical electrical equipment - Part 2. nerve and muscle stimulators for the safety requirements"
Provisions.
The standards for electromagnetic compatibility in accordance with the requirements of YY 0505 "Medical electrical equipment - Part 1-2. General requirements for safety - Collateral standard.
EMC requirements and tests "to run concurrently.
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.
The main drafters of this standard. Juan Yang, Han desert, Wu Chi-wai, Liu Bo, Li Yanan.
Interference therapy equipment
1 Scope
This standard specifies the interference current therapy apparatus (hereinafter referred to as the device) terms and definitions, classification, requirements, test methods, inspection rules, marking
Chi, instructions, packaging, transport and storage.
3.1 This standard applies to equipment regulations.
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/T 191-2008 Packaging - Pictorial signs
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 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information. General
Claim
YY 0505 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
YY 0607-2007 Medical electrical equipment - Part 2. nerve and muscle stimulation requirements for the safety
Used YY 0868-2011 nerve and muscle stimulation electrodes
3 Terms and Definitions
GB 9706.1-2007 and YY 0607-2007 defined and the following terms and definitions apply to this document.
3.1
While more than two (including two) different IF frequencies (1000Hz ~ 100000Hz frequency within the range) AC current post
Fork acts on the human body, in the low-frequency modulation current organization formed to an apparatus for treatment.
3.2
Difference frequency beatfrequency
Difference in frequency between two carriers.
3.3
Carrier carrierwave
A cyclical oscillating current. In the modulation wave, modulated frequency AC current.
3.4
Modulation modulation
By modulating a carrier wave to change certain characteristics (e.g., amplitude, frequency or phase) of the process.
3.5
Dual interference two-pathinterference
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