Testing Services
for medical equipment
Laboratory for Biocompatibility Testing of Medical Devices provide a professional biocompatibility testing with ISO/IEC:17025 standard within 14 days after receiving payment and samples (except Sterility Test which is 20 days).
We also provide custom testing for customers with medical device that require customized testing.
Services
We offer
In Vitro Cytotoxicity
Testing of a sample extract with L-929 cell lines. The result is analysed from the metabolic activity of cells. The calculation of cell viability and grading follows ISO 10993-5:2009 standard.
Bioburden
Determination of the number of microorganisms, such as bacteria and fungus, on the surface of medical devices or metal samples. The testing is done according to ISO 117347-1:2018 standard.
Sterility
Determination of the sterile level of the sample, such as the sterility of the manufactured urinary catheter. The sample must be sterilized and sealed. The testing follows ISO 11737-2:1998 standard.
In Vitro Hemolysis
Testing of a sample’s extract with diluted rabbit blood. The result is analysed from the percentage of haemoglobin from cells rupturing. The calculation and grading follow the ASTM F756 standard.
Antibacterial Susceptibility
We offer two determination methods.
- Agar diffusion method, for a qualitative measurement. *
- Broth diffusion method, for a quantitative measurement. **
Composition Analysis
Shelf-life study in climatic chamber
Temperature and humidity control cabinet for storing samples at the desired temperature and humidity
In Vitro Cytotoxicity
L-929 cell lines. The result is analysed from the metabolic activity of cells. The calculation of cell viability and grading follows ISO 10993-5:2009 standard.
Bioburden
Sterility
In Vitro Hemolysis
Antimicrobial Susceptibility
We offer two determination methods.
1. Agar diffusion method, for a qualitative measurement. *
2. Broth diffusion method, for a quantitative measurement. **
Composition Analysis
Shelf-life study in climatic chamber
Temperature and humidity control cabinet for storing samples at the desired temperature and humidity
The Testing Process
A Step-By-Step Overview
Fill the form
Fill out the form requesting for testing services.
Send an inquiry
Review of request
The laboratory will review and authorize the request.
Wait for reply
The laboratory staff will inform applicants of the results.
Send the sample
Send the sample and the form to the collection point.
Testing
Wait for results
Customers using the Fast Track service will receive testing service within 14 days after receiving payment and samples (except Sterility Test).
Fill the form
Fill out the form requesting for testing services.
Send an inquiry
Send the filled out form to the laboratory
Review of request
The laboratory will review and authorize the request.
Wait for reply
The laboratory staff will inform applicants of the results.
Send the sample
Send the sample and the form to the collection point.
Testing
The laboratory will commence the testing.
Wait for results
Customers using the Fast Track service will receive testing service within 14 days after receiving payment and samples (except Sterility Test).
F.A.Q.
Difference Between Agar Diffusion and Broth Dilution
- Agar diffusion method, which is a qualitative measurement of the antibacterial properties. For example, testing of antibacterial coated dental implant against Porphyromonas gingivalis. It is done according to CLSI M02 13th edition: 2018 standard.
- Broth diffusion method, which is a quantitative measurement of antibacterial properties. For example, the determination of the minimum inhibitory concentration of ZnO against Staphylococcus aureus. It is done according to CLSI M07 10th edition: 2015 standard.
Service Fee
Per the decree of Faculty of Engineering, Mahidol University 2022:
| Services | Rate | |
|---|---|---|
| Normal* | Fast Track* | |
| 1. Cytotoxicity | ||
| 1.1 ISO certified (in-scope) | 14,200 baht | 17,400 baht |
| 1.2 ISO uncertified (in-scope) | 10,500 baht | 14,200 baht |
| 2. Hemolysis | 10,500 baht | 31,500 baht |
| Human Blood | 5,000 Baht | |
| Rabbit Blood | 10,000 Baht | |
| 3. Composition Analysis | 2,700 baht | 5,300 baht |
| 4. Microbiology Testing | ||
| 4.1 Bioburden Testing | 1,800 baht | 5,300 baht |
| 4.2 Bioburden Validation (for sample without pores/threads/fiber) | 2,700 baht | 7,400 baht |
| 4.3. Bioburden Validation (for sample with pores/threads/fiber) | 5,300 baht | 12,600 baht |
| 4.4 Sterility Testing (14 days testing period) | 3,700 baht | 10,500 baht |
| 5. Antibacterial Susceptibility Testing | ||
| 5.1 Staphylococcus aureus | 1,800 baht | 5,300 baht |
| 5.2 Staphylococcus epidermis | ||
| 5.3 Pseudomonas aeruginosa | ||
| 5.4 Escherichia coli | ||
| 5.5 Staphylococcus aureus MRSA | ||
| 5.6 Candida albicans | 3,700 baht | 10,500 baht |
| 5.7 Porphylomonas gingivalis | 9,000 baht | 26,300 baht |
| 6. Additional Report for Cytotoxicity and Hemolysis | ||
| 6.1 English Version of the Test Report | 4,000 baht per set | |
| 6.2 Thai version of the Supporting Document | ||
| 6.3 English version of the Supporting Document | ||
Note: Supporting document includes details about sample preparation, testing process, and qualitative test result
*Normal track means that the client will receive the service within 60 days after recieving payment and samples.
**Fast Track means the customer will receive the report within 14 days after recieving payment and samples.
What is the Laboratory of Biocompatibility Testing of Medical Devices ISO/IEC 17025 certified for?
What is the minimal sample quantities?
| Testing Service | Surface Area | Weight | No. of Samples |
| 1. Cytotoxicity Testing | ≥ 200 cm2 | ≥ 10g | |
| 2. Hemolysis Testing | ≥ 500 cm2 | ≥ 30g | |
| 3. Composition Analysis | ≥ 200 cm2 | ≥ 10g | |
| 4. Microbiology Testing | |||
| 4.1 Bioburden Testing | ≥ 3 EA | ||
| 4.2 Bioburden Validation | ≥ 10 EA | ||
| 4.3 Sterility Testing | ≥ 3 EA | ||
| 4.4 Antibacterial Susceptibility Testing | |||
| 4.4.1 Agar Diffusion Method | ≥ 10 samples | ||
| 4.4.2 Broth Diffusion Method | ≥ 10 ml |