Where to get biocompatibility tested?

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