Medical devices are related to human health and safety, and their related issues have become a common focus of concern for manufacturers and consumers. Boande is an early third-party laboratory engaged in active medical device testing in China, providing long-term medical product testing services to medical device manufacturers both domestically and internationally
Test items
Routine safety tests:
Temperature rise, withstand voltage, leakage current, defibrillation protection test, mechanical test, single fault test, etc
Electromagnetic compatibility test:
Power terminal disturbance voltage, radiation disturbance, harmonic current, voltage fluctuation and flicker, electrostatic discharge immunity, radio frequency radiation immunity, power frequency magnetic field immunity, electrical fast transient pulse group immunity, radio frequency conduction immunity, surge immunity, voltage sag, short-term interruption, and voltage change immunity.
Testing of special product standards:
For example, testing of blood pressure accuracy, blood oxygen accuracy, infusion pump and infusion controller accuracy, as well as performance testing of a series of products such as monitoring, nerve and muscle stimulators.
Biocompatibility:
In vitro cytotoxicity test
Salmonella typhimurium revertant test
mutation test
Sensitization test
Gene mutation test
Skin irritation test
Thrombosis test
Intradermal stimulation test
Coagulation test
Acute systemic toxicity test
Subacute systemic toxicity test
Platelet adhesion testComplement activation test
Chronic systemic toxicity test
Muscle implantation test
Hemolysis test
Heat source test
Chromosome aberration test
Bone implantation test
Bone marrow micronucleus test
Material characteristic analysis
Subcutaneous implantation test
Function of testing report:
1. Project bidding: Issue authoritative third-party CMA/CNAS qualification report
2. Online e-commerce platform entry: Quality inspection report recognized by major e-commerce platforms 3. Used as a sales report: issuing legally effective testing reports to make consumers more confident 4. Papers and research: Provide professional personalized testing needs 5. Judicial services: providing scientific, fair, and accurate testing data 6. Industrial problem diagnosis: Verify the troubleshooting and correction of industrial production problemsBaijian and testing process:
1. Telephone communication and confirmation of requirements
2. Recommend solutions and confirm quotations 3. Mail samples and arrange testing 4. Progress tracking and result feedback 5. Provide reports and after-sales service 6. If urgent or priority processing is requiredTesting and testing characteristics:
1. The testing industry is fully covered, meeting different testing needs
2. Fully cover the laboratory and allocate localized testing nearby3. Engineers provide one-on-one services to make testing more accurate
4. Free initial testing, with no testing fees charged
5. Self service order delivery for free on-site sampling
6. Short cycle, low cost, and attentive service 7. Possess authoritative qualifications such as CMA, CNAS, CAL, etc 8. The testing report is authoritative and effective, and is generally used in China