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Brain implantation test of medical devices


The international organization for stand...

Have we identified the extractables and leachables (E & L) of medical devices correctly?


With the promulgation and implementation of the new version of iso10993-18:2020 on the chemical characterization of medical device materials in the risk management process and the public solicitation of cmde in June 2020 for the guiding principles for the review of the establishment of evaluation methods and characterization techniques for unknown leachables of medical devices (Exposure Draft) Opinions issued a notice that combining the chemical characterization and toxicological risk assessment of medical devices with the biological evaluation of biocompatibility test results has become a new trend in the development of biosafety evaluation of medical devices. E & L research in medical devices will soon become an indispensable part of the whole process of product R & D, registration and application. Due to the complex material composition and production process of some medical devices, the types and quantity of E & L produced are extremely large. It is estimated that there are tens of thousands of kinds, and the content of these chemicals in the extraction solution is small, which poses a big problem for the identification of chemicals. In the process of E & L research using various technologies of chemical characterization of medical devices, mass spectrometry, especially high-resolution mass spectrometry, can infer the molecular formula of compounds by using accurate molecular weight, which provides a practical idea for E & l work. At the same time, there are also some difficulties in the structural analysis of chemical substances based on mass spectrometry. If there is no participation of professional mass spectrometry analysts in the implementation process, the identification work is very prone to errors.

ISO 10993-23 new method of biocompatibility stimulation test - in vitro stimulation test


In January 2021, the international organ...

Biological evaluation of medical devices


In the past decades, with the development of medical technology, medical devices have brought many benefits to clinical patients. At the same time, the potential biological risks caused by their direct or indirect contact with human body have attracted more and more attention. Use of international standard ISO 10993-1, "biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process" issued by FDA in (2016), ISO 10993-1:2018 and GB / T 16886.1: all elaborated the basic principles of biological evaluation of medical devices from the perspective of risk management. At present, the equivalent transformation of GB / T 16886.1:2011 and ISO 10993-1:2018 standards has also entered the stage of soliciting opinions. Although ISO 10993 and GB / T 16886 series standards recommend in vivo and in vitro tests and corresponding test methods for biological evaluation, biological evaluation is neither a set of mandatory test list nor a simple criterion for judging whether it is qualified or unqualified, but a risk assessment process throughout the whole product development stage.

Interpretation of chemical characterization of medical device materials in iso10993-18:2020 risk management process (2) -- collection and generation of basic chemical information of devices


The qualitative and quantitative information of chemical substances introduced into the material composition and production process of medical devices is an important information input for biological evaluation and toxicological risk assessment of medical devices. The collection and generation of raw material composition and formula information is helpful to assist the study of extractable or leachable substances to identify the chemicals removed from the device materials. This information can help toxicologists better carry out toxicological risk assessment, guide biocompatibility test, and finally evaluate the potential safety risks related to medical devices and materials.

Preclinical animal study of medical devices


Preclinical animal test of medical devices is to simulate clinical use by applying medical devices to animal models. Because it is closer to the actual clinical use and expected use, it is an important means to evaluate the safety and effectiveness of medical devices for high-risk medical devices and innovative medical devices without clinical application history. Preclinical animal test of medical devices, aiming at different research and development stages and test purposes of medical devices, It is divided into feasibility study (generally carried out in the product design and development stage), safety study and effectiveness study (generally at the stage of product finalization and / or final product). According to the clinical use and characteristics of medical devices, when selecting the animal model that meets the test purpose, priority should be given to the similarity between the structure, function, metabolism and disease characteristics and the human body and its impact on the test results. The higher the similarity between the animal model and the human body, the evidence supported when extrapolating the results to the human level In terms of animal selection, the higher the level, the larger animals, such as beagle dog, Labrador dog, Bama pig, domestic pig, goat, sheep and monkey, and the experimental animals that meet relevant national / industrial standards should be selected as far as possible.

Regulatory requirements for microbial identification


The establishment of microbiological database of environmental pollution bacteria and tested bacteria through microbiological identification can be used to formulate disinfection and sterilization procedures in clean room / area, correlation analysis of tested bacteria, pollution traceability, and important judgment basis for determining whether to retry, which is of great significance to ensure product quality and the reliability of sterility inspection results. National laws and regulations also put forward clear requirements for microbial identification and identification level, which are summarized below. Microbial identification refers to the process of distinguishing bacteria, yeasts and molds, or determining the level of genera, species and strains by measuring the characteristics of unknown microorganisms with the help of the existing classification system (general rule 9204 of Chinese Pharmacopoeia). According to the Chinese and American Pharmacopoeia, GMP guidelines and PDA tr70, pharmaceutical / device manufacturers need to identify microorganisms under the following circumstances: (1) colonies isolated from the clean room environment (2) positive sterility test results (3) suspicious colonies found in the control bacteria inspection of non sterile drugs (4) microbiological deviation investigation, etc.

Interpretation of chemical characterization of medical device materials in iso10993-18:2020 risk management process (1) - framework, function and basic process of chemical characterization


Update and significance of new iso10993-...

Good news | Wuxi apptec testing division successfully obtained CMA qualification certificate for medical device testing


Wuxi apptec successfully obtained CMA qualification certificate On July 10, 2020, Wuxi apptec Suzhou, the testing division of Wuxi apptec, successfully obtained the CMA qualification certificate. This certificate is an affirmation of the biocompatibility of the medical device testing center of Wuxi apptec testing division and the relevant testing ability and operation system of the microbiology laboratory. The medical device testing center of Wuxi apptec Testing Division will continue to be committed to providing high-level medical device product testing and consulting to serve the development of the global medical device industry.