Industry Standard System And Control Requirements About Chiba Needle

Industry standard system and quality control requirements
The Chiba needle, as a Class II or Class III medical device, its quality standards directly affect the life safety of patients. In 2025, with the continuous improvement of industry standards and the continuous strengthening of regulatory policies, the quality control system of the Chiba needle will be further improved, providing technical support for the healthy development of the industry.
In terms of product definition and classification, the Chiba needle has a clear medical application definition. According to the data from DrugCompass, the Chiba biopsy needle is used to draw tissues and cells and is applicable for breast, kidney, liver, lung, thyroid, lymph node, and other soft tissue mass biopsies. The product consists of a needle tube, liner core, needle base, liner core base, and depth-limiting device. Among them, the needle tube and liner core materials are stainless steel, the depth-limiting device material is polyethylene, and the needle base and liner core base materials are polycarbonate and acrylonitrile-butadiene-styrene (ABS) materials. The product is sterilized packaging and is sterilized using ethylene oxide.
In terms of compliance with standards, the Chiba needle needs to meet specific industry standards. The standard for the aspiration biopsy needle is YZB/USA 1192-2013 "Aspiration Biopsy Needle". The approval number is National Food and Drug Administration for Medical Devices (Import) No. 2013-3151455. These standards ensure the basic quality and safety requirements of the product.
In terms of the certification system, Chiba needles need to obtain multiple international certifications. According to the data from MedicalExpo, the certifications for disposable aspiration biopsy needles (Chiba) include CE, CFDA, and FSC. The quality management system needs to comply with the ISO 13485 standard. These certifications are the basic requirements for the product to enter different markets and are also an important guarantee for quality control.
In terms of technical parameters, the Chiba needle has detailed specifications. The product specifications include diameters of 20G, 22G, 21G, 12G, 18G, 23G, 27G, 25G, 13G, 15G, 11G, 17G, 19G, 26G, 14G, 16G, and 24G, among others. The length range is from 30mm to 400mm. These technical parameters need to be strictly controlled within the allowable error range.
In terms of material selection, stainless steel is the main material for Chiba needles. By 2023, stainless steel will dominate the global Chiba needle market, accounting for more than 55% of the market revenue. Its durability, corrosion resistance, and cost-effectiveness make it the preferred choice for various applications. However, with technological advancements, new materials such as titanium, tungsten carbide, and diamond are expanding the application boundaries.
In terms of sterilization requirements, the Chiba needles need to be sterilized using an effective method. The product is sterilized in a packaging form using ethylene oxide. The residual amount of ethylene oxide after sterilization should be less than 10 μg/g, which complies with relevant safety standards. The product should be in a single-use sterile packaging to ensure safe use.
In terms of performance testing, the Chiba needle needs to undergo multiple rigorous tests. The puncture needle tube is made of medical-grade stainless steel, with moderate hardness and toughness, ensuring a smooth puncture process and preventing deformation or fracture. The needle tip is designed with a sharp triangular or conical shape, resulting in low puncture resistance and the ability to quickly penetrate tissues. Various outer diameter specifications are available to meet different surgical needs.
In terms of clinical application requirements, the Chiba needle needs to have excellent compatibility. The product should have good compatibility with mainstream interventional radiology equipment on the market. The insertion and removal of the instrument through the cannula should be smooth without any jamming. The inflation valve switch should be operable flexibly, with distinct on/off indicators. When the valve is opened, the gas flows smoothly, enabling the rapid establishment of the operation channel. After closing, the sealing performance is good, with no leakage.
In terms of the quality control system, enterprises need to establish a complete quality management system. They should produce in strict accordance with the ISO13485 quality system. CE and ISO 13485 certifications are basic requirements. The shelf life is usually 5 years. These systems ensure quality control throughout the entire process from raw material procurement to final production.
In terms of regulatory policies, the Kiyama needles need to comply with the requirements of the National Medical Products Administration. With the increasing support from national policies for domestic medical devices, the market share of domestic Kiyama needles has been increasing year by year. It is expected that by 2028, the market share of domestic Kiyama needles will exceed 60%, and breakthroughs will be achieved in some high-end product areas.
In terms of international standards, Chiba needles need to refer to advanced international standards. With the integration of the global medical market, products need to meet the requirements of different countries and regions. Enterprises need to adjust their product designs and quality control standards according to the regulatory requirements of the target markets.
These industry standards and quality control requirements form the fundamental guarantee for the safety and effectiveness of Chiba needles. With the advancement of technology and changes in clinical needs, the relevant standards are constantly being updated and improved. Manufacturers need to closely monitor the changes in standards and promptly adjust their production processes and quality control systems to ensure that the products always meet the latest standard requirements.