Medical device product inspection and testing workflow:
1. Sample reception and registration
Sample reception and registration are the first steps in the inspection and testing of medical device products. After receiving the sample
Samples need to be registered and relevant information recorded, such as sample name, model, specifications, and quantity Quantity, etc.
2. Appearance quality inspection
Appearance quality inspection is the assessment of whether the appearance of medical device products is intact and in compliance with relevant standards
Request for evaluation. Mainly including appearance defects, dimensional deviations, surface treatment, and other aspects.
3. Physical performance testing
Physical performance testing is the measurement of the mechanical changes that may occur during the use of medical device products
Try. Mainly including pressure resistance, tensile resistance, bending resistance, and other aspects.
4. Chemical performance testing
Chemical performance testing is the analysis and testing of the composition and chemical characteristics of medical device products. main
Including material composition, solubility, pH, and other aspects.
5. Biocompatibility testing
Biocompatibility testing is to determine whether medical device products may cause allergic reactions when in contact with human tissues
Conduct an evaluation. Mainly including skin irritation test, mucosal irritation test, injection test, etc.
6. Microbial testing
Microbial testing is the detection of pathogenic bacteria in medical device products. Mainly including bacterial culture
In terms of breeding experiments, fungal culture experiments, etc.
7. Electrical safety testing
Electrical safety testing is the assessment of whether medical device products with electrical components comply with relevant electrical safety standards
Allow for evaluation. This mainly includes insulation resistance testing, leakage current testing, and other aspects.
8. Radiation safety testing
Radiation safety testing is the assessment of whether medical devices containing radioactive elements comply with relevant radiation safety standards
Evaluate according to standards. Mainly including radiation dose testing, radiation pollution detection, and other aspects.
9. Environmental adaptability testing
Environmental adaptability testing is the testing of the usage of medical devices under different environmental
conditions, mainly including temperature, humidity, air pressure, and other aspects.
10. Functional performance testing
Functional performance testing is an evaluation of whether the functionality of medical device products meets relevant standard requirements. Mainly
including aspects such as service life, stability and accuracy.
11. Report preparation and review
Report preparation and review are the final steps in the inspection and testing of medical device products. After completing all tests, the test results need
to be compiled into a report and reviewed to ensure the accuracy of the report content.
Overview of Medical Device Product Inspection and Testing Work:
The inspection and testing of medical device products refers to the various technical and safety performance of the produced medical device products
Testing to ensure compliance with national and industry standards, while ensuring the health and safety of users. Medical devices Product inspection
and testing is a complex and rigorous process that requires professional personnel to operate and strictly follow relevant regulations Set and standardize.