Medical Device ISO 10993 Biocompatibility Test Laboratory

China JJR Laboratory is an IEC 17025 and GLP accREDited laboratory, providing biocompatibility testing services for medical devices, including:

- Absorbent products for incontinence treatment

- Adhesives

- Blood collection and storage devices

- Bone void fillers

- Central nervous system implants

- Combination products

- Contact lenses

- Dental implants

- Devices containing antiMICrobial agents

- Device raw materials

- IntraocULar lenses

- Orthopedic implants

- Surgical sutures

- Vascular catheters

- Wound drainage devices

- Hemodialysis disposables

- Laparoscopes and endoscopes

- Ostomy devices

- Syringes

- Artificial blood vessels

- Implantable drug delivery devices

- Prosthetic eyes

- Reusable devices

- Urological stents

- Vascular stents

- Infusion/transfusion devices

- Orthodontic devices

- Surgical gloves

- Urological catheters

- Ventricular assist devices

- Wound dressings

cytotoxicity tests

- Cytotoxicity test (3 weeks)

- Cytotoxicity test (MTT method) (iso 10993-5)

- Cytotoxicity test (Agar overlay method) (ISO 10993-5 / USP 87)

- Cytotoxicity test (Filter method) (ISO 10993-5)

- Cytotoxicity test (Direct contact method) (ISO 10993-5 / USP 87)

- Cytotoxicity test (Elution method) (USP 87)

Skin Irritation and Sensitization Tests

- Sensitization test (Maximization/patch method) (iso 10993-10) (6-8 weeks)

- Skin irritation test (ISO 10993-10) (3 weeks)

- Intradermal irritation test (ISO 10993-10 / USP 88) (3 weeks)

- Oral irritation test (Histopathological analysis required) (ISO 10993-10) (8-10 weeks)

- Vaginal irritation test (Histopathological analysis required) (ISO 10993-10) (8-10 weeks)

- Penile irritation test (Histopathological analysis required) (ISO 10993-10) (8-10 weeks)

- Rectal irritation test (Histopathological analysis required) (ISO 10993-10) (3 months)

- Eye irritation test (ISO 10993-10) (3-4 weeks)

Systemic Toxicity Tests

- Acute systemic toxicity test (ISO 10993-11 / USP 88) (3 weeks)

- Subacute systemic toxicity test (14/28 days) (ISO 10993-11) (6 weeks/8 weeks)

- Subchronic/chronic systemic toxicity test (90/180 days) (ISO 10993-11) (5 months/8 months)

- Pyrogen test (ISO 10993-11) (3 weeks)

- Local implant reaction test (Starting from 4 weeks)

- Subcutaneous implant test (iso 10993-6)

- Muscle implant test (ISO 10993-6)

- Bone implant test (ISO 10993-6)

Blood Compatibility Tests

- Hemolysis test (ISO 10993-4 / GB)

- Hemolysis test (ASTM F756)

- Coagulation test (ISO 10993-4 / GB)

- Platelet count test

- Complement activation test (ISO 10993-4 / GB)

- Thrombosis test (In vivo, in vitro) (ISO 10993-4 / GB)

Genotoxicity / Genetic Toxicity Tests

- Genotoxicity/mutagenicity test (ISO 10993-3)

- Bacterial reverse mutation test (8 weeks)

- Mouse lymphoma test (10 weeks)

- Chromosomal aberration test (10 weeks)

- Micronucleus test (Mouse) (10 weeks)