Method for limiting extraction of medical device
A medical device, the ultimate technology, applied in the field of medical device testing, can solve the problems of no sample sterility, deviation of residue quality calculation, interference with experimental results, etc., and achieve the effect of simple operation and thorough sterilization
Active Publication Date: 2019-09-20
SHENZHEN INST FOR DRUG CONTROL SHENZHEN TESTING CENT OF MEDICAL DEVICES
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Problems solved by technology
The guideline describes the process in a general way, and the operator often ignores the unstable physical and chemical properties of the glass pear-shaped bottle during the testing process, which leads to deviations in the calculation of the residue mass in the sample
Extreme extraction involves large precision instruments such as balances and vacuum concentration devices, so the entire experimental process cannot be carried out in a sterile environment
However, in genotoxicity experiments using cells and bacteria cultured in vitro, it is necessary to ensure the sterility of the samples, otherwise it will interfere with the experimental results
However, the guidelines provided by the standard do not include instructions on how to maintain the sterility of the sample
Method used
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Experimental program
Comparison scheme
Effect test
Embodiment 1
[0052] A method for extreme extraction of samples used for genotoxicity evaluation of medical devices, comprising the following steps:
[0053] (1) Ceramics provided by Shandong Medical Device Product Quality Inspection Center are used as test samples;
[0054] (2) Get two quartz pear-shaped bottles to wash and dry, number 1 and 2, put them into a vacuum desiccator and keep vacuum drying for one hour, then weigh them on a 100,000-level balance, and record the masses as 89.5267g and 100.4190g;
[0055] (3) Continue to put the two quartz pear-shaped bottles into the vacuum desiccator to keep them vacuum-dried for one hour, then weigh them on the same 100,000-level balance, and record the mass of the quartz pear-shaped bottles numbered 1 and 2 They are 89.5265g and 100.4187g respectively, and the difference from the previous weighed mass does not exceed 0.3mg, which is regarded as a constant weight. The net weight of the number 1 and 2 quartz bottles is recorded as 89.5265g acco...
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The invention provides a method for limiting extraction of a medical device. The method comprises: placing a sample in a pear-shaped bottle made of a quartz material; and then carrying out vacuum drying to realize a constant weight so as to obtain the accurate mass. According to the provided method, the control of the constant weight becomes accurate during the limiting extraction process; and the obtained sample is sterilized and the detection result is accurate.
Description
technical field [0001] The invention belongs to the field of medical device testing, and relates to a method for limit extraction of medical devices, in particular to a method for limit extraction of medical devices before genotoxicity detection. Background technique [0002] According to GB T 16886.1 / ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Tests in the Risk Management Process, genotoxicity evaluation has become a necessary experiment in the preclinical biological safety evaluation of long-term human contact devices project. The genotoxicity testing and evaluation methods of biomedical materials and related medical devices mainly include ISO 10993-3 Biological evaluation of medical devices—Part 3 Tests forgetoxicity, carcinogenicity and Chinese national standard GB / T 16886.3 Biological evaluation of medical devices Part 3: Genotoxicity, Carcinogenicity and reproductive toxicity tests. There is consistency between the two standards. [0...
Claims
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IPC IPC(8): G01N1/40
CPCG01N1/4055G01N2001/4061
Inventor 林钟石黄虹蓉刘尧林骏钟文雨缪剑虹梁永羿冼嘉华
Owner SHENZHEN INST FOR DRUG CONTROL SHENZHEN TESTING CENT OF MEDICAL DEVICES