YY/T 2005-2026Traditional Chinese medical device - Acupotomy (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the Standardization Technical Unit for Traditional Chinese Medicine Instruments (SMD/TU 008). This document was drafted by: Suzhou Medical Supplies Factory Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, and Jiangxi Provincial Medical Device Inspection Center. Testing Center, Shanghai University of Traditional Chinese Medicine, Sichuan Laozongyi Medical Equipment Co., Ltd. The main drafters of this document are. Xu Aimin, Gao Xianghui, Meng Fanmin, Qiao Jiaqi, Sun Huili, Zhang Fen, Wu Wenting, Li Jing, and Fu Shilian. Traditional Chinese Medicine Instruments Small Needle Knife

1 Scope

YY/T 2005 is the product standard for the acupotomy instrument, the small needle-knife used in Chinese medicine to release adhesions and scar tissue. It specifies the structure, the classification and the model designations, the requirements, the packaging and the labelling, and it describes the corresponding test methods. The acupotomy sits between an acupuncture needle and a scalpel, which is precisely why it needs its own standard: it is a cutting instrument in a field where the general acupuncture needle standards do not reach. It was issued together with YY/T 2006 on electrical cupping equipment as part of the build-out of the traditional Chinese medicine device series. For a manufacturer or a distributor supplying acupotomy instruments, this is the Chinese specification the product has to meet and the reference for its labelling.

This document specifies the structure, classification, model specifications, requirements, packaging, and labeling of small needle knives, and describes the corresponding test methods. This document applies to small needle knives used in Traditional Chinese Medicine small needle knife therapy.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are listed below. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. document.

GB/T 191 Packaging and Storage Graphic Symbols

GB/T 4340.1 Metallic materials - Vickers hardness test - Part

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Small needle knife acupotomy Resembling an acupuncture needle in shape, its tip is a narrow blade, possessing both needling and cutting functions. It is used for subcutaneous or muscle incisions in traditional Chinese medicine. Medical needles.

4 Structure, classification and model specifications

4.1 Structure A small needle knife typically consists of a handle, a needle body, and a blade. The blade width is generally equal to the diameter of the needle body, and the cutting edge is sharp. A typical small needle knife... The structure and names of each component are shown in Figures 1 to 4.