YY/T 1661-2019Acupoint electrical resistance detection equipment (English PDF)
穴位阻抗检测设备
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1661-2019 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 24, 2019
Implementation date
August 1, 2020
Scope
YY/T 1661-2019 is the English-translated version of 穴位阻抗检测设备.
YY/T 1661-2019 is the Chinese pharmaceutical industry standard for acupoint electrical resistance detection equipment, the traditional Chinese medicine instrument that applies a small signal to the skin and measures the impedance at an acupoint or another specific point.
It gives the terms and definitions, the composition, the requirements and the test methods, covering the measuring signal and its limits, the accuracy and repeatability of the impedance reading, the electrodes, the display and the electrical safety.
Where a device has other functions, this standard applies only to this one. Issued on 24 July 2019, it has applied since 1 August 2020.
Found what you need?
Document preview — YY/T 1661-2019
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 Classification and 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 terms and definitions, composition, requirements, and test methods of acupoint impedance testing equipment.
This standard is applicable to the non-invasive impedance detection of acupoints or specific points on the body surface under the condition that the detection electric signal is applied to the test object.
Chinese medicine auxiliary diagnostic equipment (hereinafter referred to as equipment). For a versatile device, the content specified in this standard applies only to the device.
Acupoint impedance detection function, other functions, if there are corresponding national standards and/or industry standards, should also meet the requirements of other relevant standards.
This standard does not apply to impedance testing equipment for non-traditional Chinese medicine theory, such as. body composition analyzer, muscle electrical impedance recording equipment, brain electricity Impedance monitoring equipment, mammography electrical impedance diagnostic equipment, direct impedance blood flow imaging equipment, etc.
This standard does not include post-processing of impedance test data, and software or auxiliary diagnostics for medical analysis of test data results. Clinical functional requirements.
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 14710-2009 Environmental requirements and test methods for medical appliances
GB/T 16886.1-2011 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
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1 apply to this document.
3.1 Acupoint electrical resistance detection equipment
TCM-assisted diagnosis of non-invasive impedance detection of acupoints or specific points on the body surface under the condition that the detection electric signal is applied to the test object Broken device.
3.2 Detecting electrical signal
Between the acupoint point of the test object or the specific point of the body surface and the auxiliary electrode provided by the device or used in conjunction with the device, used for blocking Anti-detection voltage signal or current signal.
3.3 Detection electrode
The electrode directly contacting the acupuncture point of the detection object or a specific point on the body surface constitutes a pair of electrodes for impedance detection with the auxiliary electrode.
3.4 Auxiliary electrode
Relatively fixed to a specific part of the body surface of the test object (such as being held or fixed on the palm of the hand, fixed on the forehead, etc.), which serves as a reference work during detection. Capable electrode.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 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 14710-2009The environmental requirement and test methods for medical electrical equipment
- GB/T 16886.1-2011Biological 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
Similar standards
How to Download YY/T 1661-2019
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
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
YY 0505-2005 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Secure payment via Stripe
Payments accepted
YY/T 1661-2019
$150.00