Academic articles
Interpretation of chemical characterization of medical device materials in iso10993-18:2020 risk management process (1) - framework, function and basic process of chemical characterization
2020-07-27
Update and significance of new iso10993-18 standard With the promulgation of the new international standard iso10993-18:2020 biological evaluation of medical devices Part 18: chemical characterization of medical device materials in the process of risk management < 1 >, FDA subsequently issued a supplementary information table and outlined the approval contents of the new standard < 2 >. China has successively issued the draft for comments corresponding to the national standard GB / T 16886.18 and the draft for comments < 3 > of cmde guiding principles for the establishment of evaluation methods and characterization technology review of unknown leachables in medical devices, highlighting the increasing attention paid by regulators in various countries to the chemical characterization of medical device materials, The chemical characterization of medical device materials has risen to an unprecedented position in the biological evaluation of medical devices. Iso10993-18:2020 is the inevitable product of the revision of iso10993-1:2018. With the development of scientific knowledge, human beings have a further understanding of the basic mechanism of device and tissue response, and it has become a trend to minimize the number of animal tests. At the same time, the regulatory authorities of various countries also have higher and higher requirements for the biocompatibility research of medical devices. For example, some high-risk medical devices need to provide biocompatibility test results such as genotoxicity and carcinogenicity. These tests often have long cycle and high cost, which brings great trouble to medical device manufacturers. The chemical characterization of medical device materials can provide necessary chemical information. Through the toxicological risk assessment of these chemical information and combined with the data of in vivo test, the biocompatibility of medical devices can be better evaluated. If the chemical information is sufficient and scientifically and reasonably discussed and evaluated, unnecessary animal experiments can even be exempted.https://mp.weixin.qq.com/s/j2YWfV0fdrmqHS3n-ph5Gg