YY/T 0951-2015Interferential current therapy instrument (English PDF)
干扰电治疗设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2017
Scope
YY/T 0951-2015 is the English-translated version of 干扰电治疗设备.
YY/T 0951-2015 is the Chinese standard "Interferential current therapy instrument".
Its scope clause reads: 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:. Its clauses include terms and definitions.
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Document preview — YY/T 0951-2015
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C42
Issued by: National Medical Products Administration
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 3.5 Dual interference two-pathinterference
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 […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191-2008Graphical symbols marking for handling and storage of packages
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0466.1-2009Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- YY 0505Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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Related Standards
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY 0505-2005 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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