Biocompatibility Assessment

In Vivo Testing

a. Irritation Tests (skin irritation, intradermal reaction, eye irritation, penile irritation, vaginal irritation, rectal irritation, oral irritation)  GB/T 16886.10-2017 idt ISO 10993-10 2021

b. Pyrogen Test GB/T 16886.11-2021 idt ISO 10993-11 2017

c. Implantation Tests (subcutaneous implantation, muscular implantation, bone implantation, brain implantation, ophthalmic implantation, dental implantation) GB/T 16886.3-2019 idt ISO 10993-3 2014

d. Toxicity Tests (acute, subacute, subchronic, long-term) GB/T 16886.11-2021 idt ISO 10993-11 2017

e. Sensitization Tests (bipolar, closed patch) GB/T 16886.10-2017 idt ISO 10993-10 2021

f. Thrombosis Test GB/T 16886.4-2022 idt ISO 10993-4 2017

In Vitro Testing

a. Cytotoxicity (MTT method, extraction method, agar diffusion method) 

GB/T16886.11-2021 idt ISO 10993-11 2017

b. Genotoxicity (bacterial reverse mutation, chromosomal aberration, TK gene mutation, in vivo micronucleus test) 

GB/T 16886.3-2019 idt ISO 10993-3 2014

c. Hemocompatibility (hemolysis test, complement activation, platelet count, in vitro thrombosis) 

GB/T 16886.4-2022 idt ISO 10993-4 2017