On July 20, 2019, the second batch of group standard formulation work and the 3D printing medical device practitioner training meeting were officially launched, and my country’s first batch of customized medical device group standards was officially implemented.
At the same time, the 3rd Shanghai Medical Association Digital Medicine Academic Annual Conference, the “Eighth Digital Orthopedics and Minimally Invasive Spine Surgery” training course and the second batch of group standard setting work and 3D printing medical device practitioners training meeting, to four The meeting will be held in the form of linkage.
The first batch of five group standards was officially implemented
The first batch of five group standards has been officially implemented on July 20. Under the promotion of the 3D printing medical device professional committee, the first batch of 5 group standards for 3D printing medical devices will be officially approved from July 1, 2018 to 2019. It was formally implemented on July 20, 2010, during which 11 group standard drafting and discussion meetings have gone through.
Customized medical devices play an important role in promoting the development of personalized medicine. However, due to the particularity of the design and production of such products, it is difficult to ensure the safety and effectiveness of the products with conventional testing methods and evaluation methods. Therefore, the quality system and process control of such products, especially high-risk customized medical devices, are particularly important. This standard specifies the special requirements for the customized medical device quality system. The customized medical devices referred to in this standard do not include biological 3D printed medical devices. III National Group Standard Letter
This standard specifies requirements for product design and type, materials, design evaluation, test methods, quality control, manufacturing, sterilization, packaging, and information provided by the manufacturer of the matching artificial temporomandibular joint. This standard applies to matching artificial temporomandibular joints. The product is suitable for the repair or reconstruction of temporomandibular joints and adjacent bone tissues in oral and maxillofacial surgery, ENT, head and neck surgery and other operations.
This standard specifies the terms and definitions, related parties, related responsibilities, implementation conditions, development and maintenance safety requirements of the Internet information platform for the implementation process of customized additive manufacturing (3D printing) medical device products under Internet conditions.
Customized medical devices play an important role in promoting the development of personalized medicine. However, due to the particularity of the design, development and production of such devices, it is difficult for conventional testing methods and evaluation methods to ensure the safety and effectiveness of the devices. Therefore, the quality system and process control of customized medical devices is particularly important, such as personnel, design and development, raw materials, production equipment, production processes, device quality control, document management, traceability, etc., to establish a good medical-industrial interaction mechanism and implementation The whole process monitoring is of great significance to ensure the safety and effectiveness of the clinical application of customized medical devices. This standard specifies the monitoring and judgment indicators and acceptance conditions for the whole process of medical-industrial interaction of customized medical devices.
This standard specifies the methods for obtaining and analyzing the mechanical equivalent models of customized medical devices. This standard applies to the mechanical analysis of some or all of the additive manufacturing products. This standard specifies the requirements and precautions for the development of the mechanical model to predict the load-bearing condition of the mechanical equivalent model in the evaluation of the mechanical equivalent model of a customized medical device. The methods in this standard can be used to evaluate a series of customized equivalent mechanical models of medical devices to meet the requirements of the use of the devices. Model verification and validation procedures are recommended in this standard to help determine whether the mechanical equivalent model analysis follows the recommended guidelines. This standard recommends what should be included in the analysis report.
my country’s 3D printing medical devices usher in the acceleration of industrialization
The lack of relevant regulations and standards is the main problem restricting the industrial application of 3D printed medical devices in China. The implementation of the first batch of five major group standards means that my country’s 3D printed medical device standard system has been gradually established. my country’s “New Standardization Law” has given the legal status of group standards, and the implementation of group standards will accelerate the industrialization of my country’s 3D printing medical devices.
The members who participated in the first batch of 3D printing medical device group standard formulation project team include: academicians of the Chinese Academy of Engineering, the State Food and Drug Administration, the Shanghai Food and Drug Administration, clinicians, scientific research institutes, testing institutions and other technical experts and business representatives, experts 68 people, 25 companies, and 105 people in total participated in the formulation of group standards.
Secretary-General Yang Jing of the 3D Printing Medical Device Professional Committee stated that the first batch of group standards has been officially implemented, and the special committee will further promote the use of group standards, such as mutual recognition and use of each other with other group standards organizations such as biocompatible materials. Group standards.
Academician Lu Bingheng, Academician Dai Kerong, Academician Wang Yingjun of the Chinese Academy of Engineering, Dean Liu Zhongmin and Professor Tan Jun of Dongfang Hospital Affiliated to Tongji University, Professor Shen Guofang, Vice Dean of Shanghai Medical College of Medicine and other experts, and Liu Bin, Director of the Fourth Department of Medical Device Technology Evaluation Center of the State Administration of Food and Drug Administration , Guo Shuting, Deputy Director of Shanghai Drug Administration, Xu Jianguang, Chairman of Shanghai Medical Doctor Association, and other relevant leaders attended the opening ceremony of the four major joint action meetings.
During the opening ceremony, Secretary-General Yang Jing of the 3D Printing Medical Device Professional Committee presided over the training work and the launching ceremony of the second batch of team logo formulation work and the award ceremony of the second batch of team logo experts and enterprise appointment letters. Academician Lu Bingheng, Academician Dai Kerong, and Academician Wang Yingjun gave a wonderful academician report during the opening ceremony. They analyzed from different perspectives such as the construction of additive manufacturing standards, the application of 3D printing in orthopedic personalized treatment, and the 3D printing of biocompatible materials. The application and development of 3D printing technology in the field of digital medicine.
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Link to this article：The first five group standards for 3D printing medical devices are officially implemented!
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