Industry Standard System And Quality Control Requirements

Industry standard system and quality control requirements
The laparoscopic cannula, 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 for laparoscopic cannulas will be further improved, providing technical support for the healthy development of the industry.
In terms of the formulation of industry standards, Anhui Aofu Medical Equipment Technology Co., Ltd. has played a significant role. Following its initiative in formulating YY/T 1710-2020 "Single-Use Abdominal Needle Insertion Device", the company once again took the lead in drafting the medical device industry standard YY/T 1980-2025 "Single-Use Sterile Incision Protection Sleeve". This standard was proposed by the National Medical Products Administration and is under the jurisdiction of the National Surgical Instrument Standardization Technical Committee (SAC/TC94). Besides the leading entity Aofu Medical, seven well-known domestic research institutions and enterprises including Shanghai and Anhui Medical Instrument Inspection Institute, Kangji Medical, and Hangzhou Mindray participated in the drafting. The standard details the classification and marking, materials, technical requirements, test methods, labels, instructions, and packaging and transportation of single-use sterile incision protection sleeves, and is applicable to similar products used in endoscopic surgeries or open surgeries to fix, spread, expand, and isolate contaminated areas of incisions.
In December 2025, the CMDE released the "Guidelines for Review of Class II Laparoscopic Surgical Instrument Products (Revised Edition 2025)", replacing the previously implemented "Technical Review Guidelines for Laparoscopic Surgical Instruments" (Document No. 30 of 2017). This document not only comprehensively updated the 2017 version of the guidelines but also timely responded to the deepening of industry technological development and regulatory understanding, further clarifying the registration requirements for Class II reusable passive laparoscopic surgical instruments, and delineating a clear compliance path for enterprises' application processes.
The applicable objects of the guiding principles are clearly defined as reusable passive medical devices of the second category in the management classification, which are used in conjunction with laparoscopy and are for abdominal surgery operations. These devices can be classified into 15 major categories based on their shape and structure, and into 17 major categories based on their usage. It should be noted that disposable laparoscopic surgical instruments are not applicable to this guiding principle. This provides a clear basis for the regulation of different types of products.
In terms of the division of registration units, the guiding principles provide highly operational guidelines. The second part of the document lists dozens of common surgical instruments such as forceps, scissors, grasping forceps, and needle holders. In principle, these can all be regarded as belonging to the same registration unit for declaration. This provides great convenience for enterprises to register a complete set of laparoscopic surgical instruments in a series.
In terms of product technical requirements, the guiding principles require the registrant to follow the provisions of the "Notice on Issuing the Guidelines for Compiling Product Technical Requirements of Medical Devices". This clause provides the basic technical performance indicators that need to be considered for the product, but does not specify quantitative requirements. The registrant can refer to relevant national standards and industry standards and formulate corresponding requirements based on the technical characteristics of their own products.
The appearance quality requirements are strict. The head-end part of the laparoscopic surgical instruments that can be seen in the laparoscopic field of vision should be treated to eliminate possible directional reflection phenomena; other parts should generally be smooth and round, with no unexpected sharp edges, cracks, burrs, etc. on the surface. The two pieces of the pincer head of the forceps instruments should fit together perfectly, without any misalignment or shaking. The pincer teeth should be clear and complete, without any missing teeth, rotten teeth, or frayed teeth, and the blade surface of the scissors should not have rolled edges or broken edges.
In response to various risks of the product, enterprises should take corresponding measures to ensure that the risks are reduced to an acceptable level. Appendix 10-1 lists an incomplete list of possible dangerous examples related to the product in accordance with the Appendix C of GB/T 42062 standard, to help determine the risks related to the product. The registration applicant should establish, document and maintain a continuous process throughout the entire life cycle of the product in accordance with the procedures and methods stipulated in GB/T 42062, to determine the risks related to medical devices, estimate and evaluate the associated risks, control these risks and monitor the effectiveness of the above controls, in order to fully ensure the safety and effectiveness of the product.
In terms of material selection, laparoscopic cannulas not only place greater emphasis on safety and biocompatibility in the choice of materials (such as using medical-grade stainless steel, polycarbonate, etc.), but also optimize the design to enhance puncture efficiency and sealing performance. Moreover, to meet the needs of different surgical procedures, the specifications of laparoscopic cannulas are also increasing, including different lengths and diameters, to accommodate the requirements of surgeries in different areas.
The sterilization requirements are strict. The disposable laparoscopic puncture devices and kits need to be sterilized using ethylene oxide. After sterilization, the residual amount of ethylene oxide should be less than 10 μg/g, meeting the relevant safety standards. The products should be packaged in a single-use sterile form to ensure safe use.
The performance test is comprehensive. The puncture syringe is made of medical-grade stainless steel, with moderate hardness and toughness to ensure a smooth puncture process and prevent deformation or fracture; the needle tip is designed with a sharp triangular or conical shape, with low puncture resistance and the ability to quickly penetrate tissues. Various outer diameter specifications are available to meet different surgical needs; the length range is 100-150mm, suitable for the abdominal wall thickness of patients of different body types.
Compatibility testing is crucial. The product must have good compatibility with the mainstream laparoscopic surgical instruments available on the market. The instruments should be able to smoothly enter and exit the cannula without any jamming. The inflation valve should be operable flexibly, with distinct on/off indicators. When the valve is open, the gas flows smoothly, enabling quick establishment of pneumoperitoneum. After closing, the gas tightness is good, with no gas leakage.
The international standard system also provides a reference for the quality control of laparoscopic cannulas in China. International standards such as ISO 13485 (Medical Device Quality Management System), ISO 10993 (Biological Evaluation of Medical Devices), and ISO 14971 (Medical Device Risk Management) together with domestic standards form a complete quality control framework. In terms of biological safety, biological evaluation in accordance with the GB/T 16886 series standards is required to ensure that the product poses no potential harm to the human body.
The testing institutions need to select the applicable standards based on the regulations of the product's registration location, and formulate supplementary testing plans in combination with the clinical usage scenarios. For instance, for disposable laparoscopic puncture devices, additional verification of puncture performance, sealing performance, and biocompatibility is required. Such differentiated testing requirements reflect the trend of quality control moving from universality to individualization and scenario-based approaches.
With the continuous improvement of regulatory requirements and the continuous refinement of industry standards, manufacturers of laparoscopic cannulas need to establish a comprehensive quality management system, covering raw material procurement, production process control, product inspection, and after-sales service, to ensure the quality and safety of the products throughout the entire process. Only through strict quality control can they gain market trust and promote the healthy development of the industry.