ISO 10993 Cytotoxicity Testing

JJR Laboratory in China offers in vitro cytotoxicity testing services for medical devices, medical adjuncts, cosmetic products, and products that come into contact with the human body. It is a GLP-authorized laboratory and an IEC 17025-accredited laboratory.

Product Applicability

In vitro cytotoxicity testing provides comprehensive quality control solutions specifically for medical device manufacturers, pharmaceutical packaging developers, and related industries. Its product services are applicable to the following product ranges:

Meical Devices

Including but not limited to implantable medical devices (such as pacemakers, joint replacements), surgical instruments, disposable medical devices (such as syringes, infusion sets), wound dressings, etc.

All medical devices that come into contact with the internal or external parts of the human body, especially those that directly or indirectly contact patients.

Pharmaceutical Packaging Materials

Including plastic bottles, glass bottles, capsules, aluminum foil, rubber stoppers, prefilled syringes, and other packaging materials that directly contact pharmaceuticals.

Secondary packaging materials used for storing, transporting, and distributing pharmaceuticals, such as cartons, plastic bags, etc.

Biological Products

Including vaccines, blood products, cellular therapy products, gene therapy products, etc.

Any bioactive substances or biomaterials that may require specific packaging to maintain their stability and bioactivity.

Cosmetics and Personal Care Products

Including skincare products, cosmetics, shampoos, body washes, and other products that come into contact with the skin or mucous membranes.

Any product packaging that may be absorbed through the skin into the human body.

Laboratory Research and Diagnostic Products

Including reagent kits, culture media, cell culture reagents, etc., used for scientific research.

Reagents, test strips, and other products used for clinical diagnosis.

Purpose and Significance of In Vitro Cytotoxicity Testing

Purpose: To evaluate the potential of medical devices and biomaterials to cause cytotoxic reactions and predict tissue and cell reactions upon application in terminal organisms. Through in vitro cell culture techniques, growth inhibition, functional changes, cell lysis, death, or other toxic reactions in cells after exposure to the test sample can be detected.

Significance: In vitro cytotoxicity testing allows for the economical and straightforward screening of cell toxicity in batches of test samples within a short period. It provides a prerequisite for whether animal testing is conducted and offers important guarantees for the development and application of new medical devices and biomaterials.

Relevant Standards for Testing

ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in vitro Cytotoxicity
GB/T 16886.5-2007 Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity (converted from ISO 10993)
GB/T 16175-2008 Biological Evaluation Test Methods for Medical Silicone Materials
GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, and Injection Equipment for Medical Use -- Part 2: Biological Test Methods
YY/T 0127.9-2009 Biological Evaluation of Dental Devices -- Part 2: Test Methods -- Cytotoxicity Tests: Agar Diffusion Method and Membrane Diffusion Method

Service Advantages

Ensuring Safety and Compatibility of Toxicity Testing

By following international and national standards such as ISO 10993-5, USP<87>, and GB/T 16886-5, in vitro cytotoxicity testing ensures the safety and biocompatibility of the aforementioned products during design, production, and market launch.

Professional Experimental Team Ensures Reliable Testing

The JJR Laboratory team in China will provide you with accurate and reliable test results, helping your products successfully pass regulatory approvals and ensuring the safety and health of end-users.