OECD GLP certified medical device biocompatibility testing

OECD GLP certified medical device biocompatibility testing

Cosmos Biomed has an international OECD GLP certified laboratory. The safety and effectiveness of medical devices is the major goal of product certification. Medical devices that normally contact with the human body follow ISO 10993 international standard for safety risk assessment to ensure that the products passed pre-market approval. Into the request. We bring together experienced veterinarians and technical expertise in the companies. Our OECD GLP report widely acceptable by worldwide government submission.

We are convinced that service is not just a trust, but a responsibility for the rigorous control of products. Through professional test plan design, you can correctly screen the product materials or process the risk of possible risk. The test efficiency is our commitment to your service.

Service Portfolio


1. ISO 10993 and GB/T 16886 biocompatibility study plan consulting

ISO 10993-1 Biocompatibility evaluation plan consulting under risk management process
ISO 10993-3 Genotoxicity study ( AMES test: Salmonella Typhimurium Reverse Mutation Test OECD 471 /In Vitro Mammalian Cell (TK+/- cell ) gene mutation test OECD 490/ In Vitro mammalian cell chromosome aberration test OECD 473/ In Vivo mouse peripheral blood micronucleus test OECD 474)
ISO 10993-4 Hemocompatibility tests (Hemolysis test/ In-vivo Thrombogenicity in Dog/ Complement Activation – C3a, SC5b-9/ Platelet aggregation/ Partial Thromboplastin time (PTT)/ In Vitro Hemocompatibility (IVH, Complete Blood Count)
ISO 10993-5 In Vitro Cytotoxicity test (L929, 3T3, V79 cell lines)
ISO 10993-6 Muscle implantation test
ISO 10993-6 Subcutaneous implantation test
ISO 10993-6 Bone implantation test
ISO 10993-10 Rabbit skin/intracutaneous irritation test
ISO 10993-10 Skin sensitization test (Kligman Guinea Pig Maximization Test (GPMT) / Close patch)
ISO 10993-11
Acute systemic toxicity / Subacute systemic toxicity/Subchronic toxicity /Chronic systemic toxicity
ISO 10993-11 Pyrogen test
ISO 10993-17& ISO 10993-18 Chemical characteristic analysis and toxicological risk assessment
Extractable and leachable test evaluation
ICP/MS, LC/MS, GC/MS, FTIR method validation
Toxicological risk estimation (NOAEL, LOAEL & MOS, AET)
Biocompatibility Evaluation Plan and Report (BEP&BER)

2. Medical device animal performance functional study( Beagle, mini pig, goat/sheep, Monkey)

3. Reusable medical device cleaning and disinfection reprocess validation

4. ISO 18562 air flow pathway device testing

Biocompatibility Test

・In Vitro Cytotoxicity Test
・Skin Sensitization Test
・Skin Irritation Test
・Intracutaneous Test
・Acute Systemic Test
・Sub-acute Toxicity Test
・Sub-chronic Toxicity Test
・Chronic Toxicity Test
・Pyrogen Test
・Chromosome Aberration Test
・In Vivo Bone Micronucleus Test

・Hemocompatibility: Partial Thromboplastin Time (PTT)
・Hemocompatibility: Platelets
・Hemocompatibility: Complement Activation, SC5b-9
・Hemolysis Test
・Muscle Implantation Test
・Subcutaneous Implantation Test
・Bone Implantation Test
・Genotoxicity: Ames Test
・In Vitro Mammalian Cell Gene Mutation Test (TK Test)
・Hemocompatibility: Dog Thrombogenicity