YY 0951-2015Interferential current therapy instrument (English PDF)
干扰电治疗设备
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 2, 2015
Implementation date
January 1, 2017
Scope
YY 0951-2015 is the English-translated version of 干扰电治疗设备.
YY 0951-2015 is the Chinese pharmaceutical industry standard for the interferential current therapy instrument, the device that treats by crossing two medium-frequency currents in the tissue so that their interference produces a low-frequency effect.
It specifies the terms and definitions, the classification, the requirements, the test methods, the inspection rules, the marking, the instructions, and the rules for packaging, transport and storage, covering the output current and the carrier and beat frequencies and their accuracy, the treatment timer, the electrodes and the electrical safety. Issued on 2 March 2015, it has applied since 1 January 2017.
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Document preview — YY 0951-2015
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C 42
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
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.
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.
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.
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 ~
Fork acts on the human body, in the low-frequency modulation current organization formed to an apparatus for treatment.
This standard applies to equipment regulations.
3.2 Difference frequency
Difference in frequency between two carriers.
3.3 Carrier
A cyclical oscillating current. In the modulation wave, modulated frequency AC current.
3.4 Modulation
By modulating a carrier wave to change certain characteristics (e.g., amplitude, frequency or phase) of the process.
3.5 Dual interference
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 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 0505Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- YY 0607-2007Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators
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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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YY 0951-2015
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