Where to get biocompatibility tested?
One of the most basic contents of biocompatibility testing/evaluation is biosafety.
Biosafety means that materials must be non-toxic, non-allergenic, non-irritating, non-genotoxic, non-carcinogenic, and have no adverse reactions to human tissues, blood, and immune systems under the interaction between materials and the human body.
JJRLAB medical and biological laboratory has obtained China CMA and American IAS qualification certificates. At the same time, the laboratory operates in strict accordance with the GLP system. It is a laboratory recognized by government regulatory agencies such as the US FDA/Australia TGA/Brazil ANVISA, and is also a laboratory recognized by the US UL and the Canadian CSA. , TUV in Germany, SGS in Switzerland, Intertek in the UK, BSI in the UK, MEDCERT in Germany, IMQ in Italy and many other recognized laboratories and partners.
JJRLAB laboratory provides you with the most professional, efficient and comprehensive biocompatibility evaluation and biocompatibility test report services.
Test items | Reference standard | Testing cycle (weeks) |
Biocompatibility testing | ||
Cytotoxicity test | ||
Cytotoxicity test (MTT method) | ISO 10993-5/USP 87/GB/T 16886.5/ISO 7405/YY 0127.9/GB/T 14233.2 | 2 weeks |
Cytotoxicity test (agar method) | 2 weeks | |
Cytotoxicity test (filter membrane method) | 2 weeks | |
Cytotoxicity test (direct contact method) | 2 weeks | |
Cytotoxicity test (elution method) | 2 weeks | |
Irritation and sensitization testing | ||
Sensitization test (maximum dose method/patch method) | ISO 10993-10/ GB/T 16886.10/ GB/T 14233.2 | 6~8 weeks |
skin irritation test | ISO 10993-10/GB/T 16886.10 | 2 weeks |
intradermal irritation | ISO 10993-10/GB/T 16886.10/USP 88/GB/T 14233.2 | 2 weeks |
Oral irritation (histopathological reading required) | ISO 10993-10/GB/T 16886.10 | 6-8 weeks |
Vaginal irritation (histopathological reading required) | 6-8 weeks | |
Penile stimulation (histopathology reading required) | 6-8 weeks | |
Rectal irritation (histopathological reading required) | 6-8 weeks | |
Eye irritation | 4 weeks | |
Systemic systemic toxicity test | ||
Acute systemic toxicity test (intravenous/oral) | ISO 10993-11/ GB/T 16886.11/ USP88/ GB/T 14233.2 | 2 weeks |
Subacute systemic toxicity test (14 days/28 days) (without histopathological reading) | ISO 10993-11/ GB/T 16886.11/ GB/T 14233.2 | 4 weeks/6 weeks |
Subacute systemic toxicity test (14 days/28 days) (with histopathological reading) | ISO 10993-11/ GB/T 16886.11/ GB/T 14233.2 | 6 weeks/6-8 weeks |
Subchronic systemic toxicity test (90 days) | 4-4.5 months | |
Chronic systemic toxicity test (180 days) | 7.5-8 months | |
Pyrogen test | ISO 10993-11/ GB/T 16886.11/ Chinese Pharmacopoeia | 2 weeks |
implantation test | ||
Subcutaneous implantation (requires histopathological reading) in rabbits and rats | ISO 10993-6/ GB/T 16886.6/ USP 88 | |
Muscle implantation (histopathology reading required) rabbit, rat | ISO 10993-6/ GB/T 16886.6/ USP 88 | |
Bone implantation (histopathological reading required) rabbit, rat | ISO 10993-6/GB/T 16886.6 | |
blood compatibility test | ||
Hemolysis test (rabbit blood is preferred) | ISO 10993-4/ GB/T 16886.4/ GB/T 14233.2 | 2 weeks |
Hemolysis test (rabbit blood is preferred) | ASTM F756 (need to be specified by customer) | 4-6 weeks |
coagulation | ISO 10993-4/GB/T 16886.4 | 4-6 weeks |
platelet count | 4-6 weeks | |
total complement | 4-6 weeks | |
Thrombosis (in vivo (canine CTI), in vitro) | 4-6 weeks | |
Genotoxicity test | ||
Ames Salmonella Typhimurium Reverse Mutation Test | ISO 10993-3/GB/T 16886.3/YY/T 0127.10 | 6-8 weeks |
Gene mutation | ISO 10993-3/ GB/T 16886.3/ OECD 476 | 6-8 weeks |
Chromosome Aberration Test | ISO 10993-3/ GB/T 16886.3/ OECD 473 | 6-8 weeks |
Sperm aberrations (animals, rats) require microscope reading | ISO 10993-3/GB/T 16886.3 | 6-8 weeks |
Micronucleus test (animals, mice) requires microscope reading | ISO 10993-3/ GB/T 16886.3/ OECD 474 | 6-8 weeks |
For more details on biocompatibility testing and biocompatibility evaluation, please contact China JJRLAB
Email:hello@jjrlab.com
Email:hello@jjrlab.com
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