EMC China Lab

Medical Device ISO 10993 Biocompatibility Test Laboratory

Views :
Update time : 2024-07-03

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)


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
What is the ETSI EN 303 645 Testing Standard? What is the ETSI EN 303 645 Testing Standard?
04 .24.2025
ETSI EN 303 645 boosts IoT security and privacy. JJR Lab in China offers comprehensive testing to he...
UL Compliance and ETL Certification for LED Lighti UL Compliance and ETL Certification for LED Lighti
04 .24.2025
UL and ETL ensure LED safety and quality. China’s JJR Lab offers testing to meet North American stan...
What is the IEC 60598 Standard? What is the IEC 60598 Standard?
04 .24.2025
IEC 60598 ensures luminaire safety, performance, and compliance. China-based JJR Laboratory offers e...
What is the Canada IC Logo? What is the Canada IC Logo?
04 .24.2025
The Canada IC logo certifies wireless products for sale in Canada. Testing by China’s JJR Laboratory...
EMC Pre Compliance Testing EMC Pre Compliance Testing
04 .24.2025
JJR Laboratory in China offers EMC pre-compliance testing, helping clients save up to 40% on certifi...
PAHs Testing (Food and Textile) PAHs Testing (Food and Textile)
04 .24.2025
JJR Lab offers testing for PAHs in textiles, tires, and rubber products, ensuring compliance with EU...
Where to Apply for the EU RoHS Test Report? Where to Apply for the EU RoHS Test Report?
04 .24.2025
Need EU RoHS testing? JJR Lab in China offers fast, certified compliance for electronics and compone...
Children’s Products and Toy Testing Children’s Products and Toy Testing
04 .24.2025
Children’s toys impact safety and growth. China JJR Lab tests to EN 71, ASTM F963, ISO 8124, GB 6675...

Leave Your Message