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YY/T 0951-2015: Interferential current therapy instrument
Status: Valid YY/T 0951: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0951-2015 | English | 289 |
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Interferential current therapy instrument
| Valid |
YY/T 0951-2015
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| YY/T 0951-2015 | English | 289 |
Add to Cart
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3 days [Need to translate]
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Interferential current therapy instrument
| Valid |
YY/T 0951-2015
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PDF similar to YY/T 0951-2015
Standard similar to YY/T 0951-2015 YY/T 1095 YY 0950 YY 0900 YY/T 0952 Basic data | Standard ID | YY/T 0951-2015 (YY/T0951-2015) | | Description (Translated English) | Interferential current therapy instrument | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 13,135 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2017-01-01 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard is applicable to devices that simultaneously act on the human body with two or more (including two) alternating currents of intermediate frequency (within the range of 1,000 Hz to 100,000 Hz) of different frequencies to form low-frequency modulated currents in tissues for treatment. This standard specifies the terms, definitions, classifications, test methods, inspection rules, signs, instruction manuals, packaging, transportation and storage requirements for interference electrotherapy equipment. | YY/T 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.
ICS 11:040:60
C42
Pharmaceutical Industry Standard of the People's Republic of China
YY 0951-2015
interference with electrotherapy equipment
According to the State Drug Administration medical device industry
Standard Announcement (No: 76 of 2022), this standard is from
From September 7, 2022, it will be converted into a recommended standard, no
Enforce it again:
Released on:2015-03-02
2017-01-01 Implementation
Issued by China Food and Drug Administration
foreword
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
The safety requirements of this standard fully implement the requirements of GB 9706:1-2007 "Medical Electrical Equipment Part 1: General Safety Requirements"
content:
This standard is modified to adopt YY 0607-2007 "Medical Electrical Equipment Part 2: Special Requirements for Safety of Nerve and Muscle Stimulators"
Provisions:
The electromagnetic compatibility requirements of this standard comply with YY 0505 "Medical Electrical Equipment Part 1-2: General Safety Requirements Parallel Standards:
"Electromagnetic Compatibility Requirements and Tests" will be implemented at the same time:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents:
This standard was proposed by China Food and Drug Administration:
This standard is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee (SAC/TC10/SC4) of the National Medical Electrical Appliances Standardization Technical Committee:
This standard was drafted: State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center:
The main drafters of this standard: Yang Guojuan, Han Mo, Hu Zhiwei, Liu Bo, Li Yanan:
YY 0951-2015
interference with electrotherapy equipment
1 Scope
This standard specifies the terms and definitions, classifications, requirements, test methods, inspection rules, and standards for interference electrotherapy equipment (hereinafter referred to as equipment):
logo, instruction manual, packaging, transportation and storage:
This standard applies to the equipment specified in 3:1:
2 Normative references
The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document
pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 191-2008 Packaging, storage and transportation icon marks
GB 9706:1-2007 Medical Electrical Equipment Part 1: General Safety Requirements
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
YY/T 0466:1-2009 Symbols for medical device labeling, marking and providing information for medical devices Part 1: General
Require
YY 0505 Medical Electrical Equipment Part 1-2: General Safety Requirements Collateral Standard: Electromagnetic Compatibility Requirements and Tests
YY 0607-2007 Medical Electrical Equipment Part 2: Special Requirements for Safety of Nerve and Muscle Stimulators
YY 0868-2011 Electrodes for nerve and muscle stimulators
3 Terms and Definitions
The following terms and definitions defined in GB 9706:1-2007 and YY 0607-2007 apply to this document:
3:1
At the same time, two or more (including two) AC currents of different frequencies (within the frequency range of 1000Hz~100000Hz) are exchanged:
It is a device that acts on the human body to form a low-frequency modulation current in the tissue for treatment:
3:2
Beat frequency beatfrequency
The difference between the frequencies of the two carriers:
3:3
carrier wave
A periodic oscillating current: In modulated waves, an intermediate frequency alternating current is modulated:
3:4
Modulation
The process of using a modulating wave to change a certain characteristic (such as amplitude, frequency, or phase) of a carrier:
3:5
Two-path interference two-path interference
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