Biocompatibility Testing Laboratories

biocompatibility testing and Evaluation - GB/T 16886 / ISO 10993 / USP 88 / ISO 7405, etc.

biocompatibility refers to the ability of a living tissue to coexist with an inert material without adverse reactions.

Generally, it refers to the compatibility between a material and its host, including tissue compatibility and blood compatibility. Biocompatibility shoULd not cause adverse reactions to biological tissues, blood, or other bodily fluids.

One of the fundamental aspects of biocompatibility testing/evaluation is biosafety.

Biosafety refers to the interaction between a material and the human body, ensuring that it is non-toxic, non-allergenic, non-irritating, non-mutagenic, non-carcinogenic, and does not cause adverse reactions in human tissues, blood, or the immune system.

China JJR Biocompatibility Testing Laboratory has obtained certifications from both the China CMA and the United States IAS, and the laboratory operates strictly in accordance with GLP standards. It is recognized by regulatory bodies such as the US FDA, Australia TGA, and Brazil ANVISA. Additionally, it is a recognized partner of international organizations such as UL (United States), CSA (Canada), TUV (Germany), SGS (Switzerland), Intertek (UK), BSI (UK), MEDCERT (Germany), and IMQ (Italy).

China JJR Laboratory provides professional, efficient, and comprehensive biocompatibility evaluations and biocompatibility testing reports.

Biocompatibility Testing:

- cytotoxicity testing:  

  Cytotoxicity Test (MTT Method): iso 10993-5 / USP 87 / GB/T 16886.5 / ISO 7405 / YY 0127.9 / GB/T 14233.2, duration: 2 weeks.  

  Cytotoxicity Test (Agar Method), duration: 2 weeks.  

  Cytotoxicity Test (Membrane Method), duration: 2 weeks.  

  Cytotoxicity Test (Direct Contact Method), duration: 2 weeks.  

  Cytotoxicity Test (Extraction Method), duration: 2 weeks.

- Irritation and sensitization testing:  

  Sensitization Test (Maximization/Patch Method): iso 10993-10 / GB/T 16886.10 / GB/T 14233.2, duration: 6–8 weeks.  

  Skin Irritation Test: ISO 10993-10 / GB/T 16886.10, duration: 2 weeks.  

  Intradermal Irritation Test: ISO 10993-10 / GB/T 16886.10 / USP 88 / GB/T 14233.2, duration: 2 weeks.  

  Oral Irritation Test (Requires Histopathology): ISO 10993-10 / GB/T 16886.10, duration: 6–8 weeks.  

  Vaginal Irritation Test (Requires Histopathology), duration: 6–8 weeks.  

  Penile Irritation Test (Requires Histopathology), duration: 6–8 weeks.  

  Rectal Irritation Test (Requires Histopathology), duration: 6–8 weeks.  

  Ocular Irritation Test, duration: 4 weeks.

- Systemic Toxicity Testing:  

  Acute Systemic Toxicity Test (Intravenous/Oral): ISO 10993-11 / GB/T 16886.11 / USP 88 / GB/T 14233.2, duration: 2 weeks.  

  Subacute Systemic Toxicity Test (14/28 days) (Without Histopathology): ISO 10993-11 / GB/T 16886.11 / GB/T 14233.2, duration: 4 weeks / 6 weeks.  

  Subacute Systemic Toxicity Test (14/28 days) (With Histopathology): ISO 10993-11 / GB/T 16886.11 / GB/T 14233.2, duration: 6 weeks / 6–8 weeks.  

  Subchronic Systemic Toxicity Test (90 days), duration: 4–4.5 months.  

  Chronic Systemic Toxicity Test (180 days), duration: 7.5–8 months.  

  Pyrogen Test: ISO 10993-11 / GB/T 16886.11 / Chinese Pharmacopoeia, duration: 2 weeks.

- Implantation Testing:  

  Subcutaneous Implantation (Requires Histopathology) Rabbits, Rats: iso 10993-6 / GB/T 16886.6 / USP 88.  

  Muscle Implantation (Requires Histopathology) Rabbits, Rats: ISO 10993-6 / GB/T 16886.6 / USP 88.  

  Bone Implantation (Requires Histopathology) Rabbits, Rats: ISO 10993-6 / GB/T 16886.6.

- Blood Compatibility Testing:  

  Hemolysis Test (Preferred Rabbit Blood): ISO 10993-4 / GB/T 16886.4 / GB/T 14233.2, duration: 2 weeks.  

  Hemolysis Test (Preferred Rabbit Blood): ASTM F756 (Client Specified), duration: 4–6 weeks.  

  Coagulation Test: ISO 10993-4 / GB/T 16886.4, duration: 4–6 weeks.  

  Platelet Count, duration: 4–6 weeks.  

  Total Complement Activation Test, duration: 4–6 weeks.  

  Thrombosis Test (In Vivo (Dog CTI), In Vitro), duration: 4–6 weeks.

- Genotoxicity Testing:  

  Ames Test (Salmonella Typhimurium Reverse Mutation): ISO 10993-3 / GB/T 16886.3 / YY/T 0127.10, duration: 6–8 weeks.  

  Gene Mutation Test: ISO 10993-3 / GB/T 16886.3 / OECD 476, duration: 6–8 weeks.  

  Chromosome Aberration Test: ISO 10993-3 / GB/T 16886.3 / OECD 473, duration: 6–8 weeks.  

  Sperm Abnormality Test (Animals, Rats) Requires Microscopic Analysis: ISO 10993-3 / GB/T 16886.3, duration: 6–8 weeks.  

  Micronucleus Test (Animals, Mice) Requires Microscopic Analysis: ISO 10993-3 / GB/T 16886.3 / OECD 474, duration: 6–8 weeks.

For more details on ISO 10993 and ISO 18562 biocompatibility testing and evaluation, please contact China JJR Medical and Biological Laboratories.