YY/T 1666-2019Meridian stimulator (English PDF)
经络刺激仪
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 24, 2019
Implementation date
August 1, 2020
Scope
YY/T 1666-2019 is the English-translated version of 经络刺激仪.
YY/T 1666-2019 is the Chinese pharmaceutical industry standard for the meridian stimulator, the traditional Chinese medicine device that delivers low-frequency pulses of up to about 1500 V peak, measured across a 20 kohm load, through electrodes placed on acupoints or other points of the body surface.
It gives the composition, the requirements and the test methods, covering the output waveform, its amplitude, width and repetition rate and their accuracy, the limits on charge and energy delivered, the electrodes, the controls and alarms and the electrical safety. Issued on 24 July 2019, it has applied since 1 August 2020.
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Document preview — YY/T 1666-2019
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
- 4 composition
- 5 Requirements
- 6 Test method
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the composition, requirements, and test methods of meridian stimulators (hereinafter referred to as equipment).
This standard is applicable to the application of non-invasive peaks to acupoints or specific parts of the body surface through electrodes that are in direct contact with the patient.
1500V high voltage [load impedance 20 (1 ± 10%) kohm] low-frequency pulse electrical signal, dredge the lesion area and the corresponding meridian points, to the Chinese medicine guide Equipment for the treatment of flat therapy. For a versatile device, the content specified in this standard applies only to the meridian stimulation of the device.
Function, other functions, if there are corresponding national standards and/or industry standards, should also meet the requirements of other relevant standards.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB/T 14710 Medical electrical requirements and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing
YY 0607 Medical electrical equipment - Part 2. Safety requirements for nerve and muscle stimulators
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1 and YY 0607 apply to this document.
3.1 Apply non-invasive 1500V high pressure to acupoints or specific parts of the body surface through electrodes that are in direct contact with the patient [negative
Load impedance 20 (1 ± 10%) kohm] low-frequency pulse electrical signal, dredge the lesion area and the corresponding meridian point points, with the Chinese medicine guide level therapy Equipment for treatment.
3.2 Polarity conversion
The function of changing the polarity of the output pulse signal of the device.
3.3 Gradient output
An output mode in which the pulse width or pulse repetition frequency is between the specified upper and lower limits, periodically varying with time.
3.4 Intensity increment automaticallystrengthincrease
The output pulse amplitude is increased to the specified upper limit of the amplitude at a predetermined time interval based on the set initial pulse amplitude.
3.5 Thruster massagerolerandelectrode
A hand-held electrode with a roller device that can introduce a pulse signal to a patient through a roller when manually performing mechanical massage.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710The 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 0607Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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
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YY/T 1666-2019
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