Standards Development

Scope

This document specifies the general requirements and test methods of Chuzhen instruments. It is only applicable to non-disposable Chuzhen instruments.

This document is not applicable to non-invasive meridian and acupoint stimulators with electrical, magnetic, or laser characteristics.

Purpose

Non-invasive meridian and acupoint stimulators are essential external instruments of traditional Chinese medicine, with a rich historical background, diverse typology, and a thriving global market. As a commonly utilized non-invasive meridian and acupoint stimulator, Chuzhen instruments stimulate acupoints, meridians, muscles and fascia through manipulations such as tapping, pressing, scraping, and rotating to prevent and treat diseases. It is a non-disposable instrument with “a set of four pieces”, which can effectively stimulate different areas of the body. Numerous clinical research projects have shown that Chuzhen therapy is effective in treating various systemic diseases. With the widespread application and recognition of traditional Chinese medicine culture worldwide, Chuzhen instruments has been used in Germany, the Netherlands, France, China, Malaysia, South Africa and other countries. Meanwhile, Chuzhen instruments have been promoted in New Zealand, Switzerland, Bosnia and Herzegovina, Malta, Portugal, Pakistan, Nepal, Uzbekistan, Algeria, Zambia, Tunisia, Lesotho, Tanzania, Ethiopia, Guinea Bissau and other countries. The safety and quality of Chuzhen instruments are closely linked to the safety and efficacy of Chuzhen therapy. Currently, there are a wide variety of Chuzhen instruments available on the market, presenting issues such as excessive sharpness at the tip, high surface roughness, and immature structural design. However, there is no standardized guidance for their manufacturing and processing. This lack of standardization poses potential safety risks and raises concerns among operators and consumers, hindering international trade, technological inheritance, and industry development. According to statistics, the traditional Chinese medicine instrument market is expected to continue growing rapidly in the coming years, making the increasing demand for instruments a focal point for manufacturers worldwide. Based on the several issues and market demands of these instruments mentioned above, standardizing Chuzhen instruments is necessary to enhance product quality, protect consumer safety, facilitate government refinement of relevant standards and regulatory measures, and promote standardized professional training............In order to provide better health care services in various countries and better benefit global trade, the instrument should be standardized first. This document specifies the structure, dimensions, appearance inspection, materials, hardness, weight, roughness, abrasion resistance, corrosion resistance, cleaning and disinfection, safety requirements, packaging, transportation, and storage of Chuzhen instruments. Standardizing Chuzhen instruments will enhance their safety and quality, with the aim of promoting more scientific, safe, and effective global use of Chuzhen instruments while also facilitating international trade.