ISO 10993 In Vitro Cytotoxicity Testing

In vitro cytotoxicity testing uses cell culture techniques to determine:

- Cell death (e.g., cell lysis)

- Cell growth inhibition

- Colony formation

- Other effects on cells caused by medical devices, materials, or their extracts.

In the biological evaluation system of medical devices, in vitro cytotoxicity testing is one of the most important indicators. It helps evaluate the potential cytotoxicity of medical devices and biomaterials. Before these devices are used on living tissues or cells, in vitro cytotoxicity testing serves as a simulated experiment to predict the biological response. The method is economical, simple, and allows for batch testing, which makes it an essential screening tool for deciding whether animal testing is necessary.

Evaluation Criteria

In vitro cytotoxicity assays can be categorized based on endpoint measurements:

- Morphological assessment of cell damage

- Measurement of cell damage

- Measurement of cell growth

- Measurement of specific aspects of cell metabolism

Solutions

JJR Lab in China has years of experience in cytotoxicity testing, with a comprehensive testing system for both medical devices and biomaterials. Cytotoxicity testing methods are generally divided into:

1. Quantitative Cytotoxicity Testing

2. Qualitative Cytotoxicity Testing

Quantitative Cytotoxicity Testing: MTT Assay

Principle:  

The MTT assay is based on observing cell metabolic activity. MTT is a yellow water-soluble reagent that is reduced by viable cells into a purple-blue formazan. This formazan is then dissolved in isopropanol, and the optical density is measured using a spectrophotometer. The number of viable cells is directly proportional to the optical density.

Reference Standards:

- ISO 10993-5:2009 — Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity

- ISO 10993-12:2021 — Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials

- GB/T 16886.5-2017 — Biological Evaluation of Medical Devices – Part 5: In Vitro Cytotoxicity Test

Notes:  

The laboratory sample collection method typically uses extraction liquid for testing. The appropriate extraction ratio should be selected based on the sample's characteristics and thickness, followed by further cutting of the sample if necessary.

Qualitative Cytotoxicity Testing: ISO Method

Principle:  

Medical device extracts are cultured with cells, and biological reactions are observed under a microscope. Evaluation includes assessing:

- Cell morphology

- Vacuolation

- Cell detachment

- Lysis

- Membrane integrity

These aspects are followed by a rating to determine the cytotoxic effect.

Reference Standards:

- ISO 10993-5:2009 — Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity

- GB/T 16886.5-2017 — Biological Evaluation of Medical Devices – Part 5: In Vitro Cytotoxicity Test

Qualitative Cytotoxicity Testing: USP Method

Principle:  

This method examines the effects of leachates from elastic or polymeric materials (which directly or indirectly contact the patient) on cell morphology, to determine the biological reaction of the extracts.

Reference Standards:

- USP-NF <87> — Biological Reactivity Tests, In Vitro: Elution Test

Cytotoxicity testing requires extensive preparation, including reagents like culture media and cells. Since cell growth takes time, the testing cycle can be lengthy and may affect the scheduling of tests.

JJR Lab has extensive experience in in vitro cytotoxicity testing. We can adjust preparation times and schedule testing efficiently, aiming to provide the best possible quality control services to our customers.

Our in vitro cytotoxicity testing team consists of highly skilled professionals who can customize testing methods according to your specific needs. We operate to the highest quality standards and are committed to delivering professional, reliable quality control services.