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.
We also provide custom testing for customers with medical device that require customized testing.

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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.

  1. Agar diffusion method, for a qualitative measurement. *
  2. Broth diffusion method, for a quantitative measurement. **

Composition Analysis

Detection of heavy metals in the medical device sample, such as the concentration of silver. The sample is dissolved, its content is measured with an atomic absorption spectrophotometer (AAS).

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.

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

Detection of heavy metals in the medical device sample, such as the concentration of silver. The sample is dissolved, its content is measured with an atomic absorption spectrophotometer (AAS).

The Testing Process

A Step-By-Step Overview

1

Fill the form

Fill out the form requesting for testing services.
Download
2

Send an inquiry

Send the filled out form to the laboratory
3

Review of request

The laboratory will review and authorize the request.

4

Wait for reply

The laboratory staff will inform applicants of the results.

5

Send the sample

Send the sample and the form to the collection point.
Download
6

Testing

The laboratory will commence the testing.
7

Wait for results

Customers using the Fast Track service will receive results within 14 days.
i
1

Fill the form

Fill out the form requesting for testing services.

Download
2

Send an inquiry

Send the filled out form to the laboratory

k
3

Review of request

The laboratory will review and authorize the request.

4

Wait for reply

The laboratory staff will inform applicants of the results.

5

Send the sample

Send the sample and the form to the collection point.

Download
6

Testing

The laboratory will commence the testing.

7

Wait for results

Customers using the Fast Track service will receive testing service within 14 days.

F.A.Q.

Difference Between Agar Diffusion and Broth Dilution
Antibacterial Susceptibility testing is a determination of antibacterial properties of the sample. It is consisting of two methods:

  1. 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.
  2. 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 Within ISO Guide 13,500 16,500 baht
     1.2 Outside ISO Guide 10,000 baht 13,500 baht
2. Hemolysis 10,000 baht 30,000 baht
3. Composition Analysis 2,500 baht 5,000 baht
4. Bacteria
     4.1 Bioburden Testing 1,700 baht/sample 5,000 baht/sample
     4.2 Bioburden Testing with Identification 2,500 baht/sample 7,000 baht/sample
     4.3 Sterility Testing 3,500 baht/sample 10,000 baht/sample
 5. Antibacterial Susceptibility Testing
     5.1 Staphylococcus aureus 1,700 baht/sample 5,000 baht/sample
     5.2 Staphylococcus epidermis
     5.3 Pseudomonas aeruginosa
     5.4 Escherichia coli
     5.5 Staphylococcus aureus MRSA
     5.6 Candida albican 3,500 baht/sample 10,000 baht/sample
     5.7 Porphylomonas gingivalis 8,500 baht/sample 25,000 baht/sample
6. Additional Report for Cytotoxicity and Hemolysis
     6.1 Result Report in English 2,750 baht per set
     6.2 Complimentary Documents (Thai and English)
7. Additional Report for Composition Analysis and Bacteria
     7.1 Result Report in English 2,750 baht per set
     7.2 Complimentary Documents (Thai and English)

*Normal means the testing service will be done per the order of sample submission
**Fast Track means the customer will receive the report within 2 weeks after payment.

What is the Laboratory of Biocompatibility Testing of Medical Devices ISO/IEC 17025 certified for?
Laboratory of Biocompatibility Testing of Medical Devices is certified for cytotoxicity testing of medical devices such as wound dressing.

Learn more

What is the minimal sample quantities?
We require different amount of sample for each testing, as follows:

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