STC's Biocompatibility Testing services for medical devices includes:
- Absorbent Incontinence Products
- Adhesives
- Blood Collection & Storage Devices
- Bone Void Fillers
- Central Nervous System Implants
- Combination Products
- Contact Lenses
- Dental Implants
- Devices Containing Antimicrobials
- Device Raw Materials
- Hemodialysis Disposables
- Implantable Drug Delivery Devices
- Infusion / transfusion Devices
- Intraocular Lenses
- Laparoscopes & Endoscopes
- Ocular Implants
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- Orthodontic Devices
- Orthopedic Implants
- Ostomy Devices
- Reusable Devices
- Surgical Gloves
- Sutures
- Syringes
- Urinary Stents
- Urologic Catheters
- Vascular Catheters
- Vascular Grafts
- Vascular Stents
- Ventricular Assist Devices
- Wound Drainage Devices
- Wound Dressings
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Cytotoxicity Study Test (3 weeks lead time)
- MTT Method (ISO 10993-5)
- Agarose Overlay Method (ISO 10993-5 / USP 87)
- Filter Diffusion Method (ISO 10993-5)
- Direct Contact Method (ISO 10993-5 / USP 87)
- MEM Method (USP 87)
Irritation & Skin Sensitization Test
- Skim Sensitization Study (GPMT / Closed-patch) (ISO 10993-10) (6 - 8 weeks)
- Skin Irritation Test (ISO 10993-10) (3 weeks)
- Intracutaneous (Intradermal) Reactivity Test (ISO 10993-10 / USP 88) (3 weeks)
- Oral Mucosa Irritation Test (ISO 10993-10) (8 - 10 weeks)
- Vaginal Irritation Test (ISO 10993-10) (8 - 10 weeks)
- Penile Irritation Test (ISO 10993-10) (8 - 10 weeks)
- Rectal Irritation Test (ISO 10993-10) (3 months)
- Ocular Irritation Test (ISO 10993-10) (3 - 4 weeks)
Systemic Toxicity Test
- Acute Systemic Toxicity Test (ISO 10993-11 / USP 88) (3 weeks)
- Subacute Systemic Toxicity Test (14 days / 28 days) (ISO 10993-11) (6 or 8 weeks)
- Subchronic Systemic Toxicity Test (90 days / 180 days) (ISO 10993-11) (5 or 8 months)
- Pyrogen Test (ISO 10993-11) (3 weeks)
Local Effects after Implantation Test (ISO 10993-6) (at least 4 weeks)
- Implantation in Subcutaneous Tissue Test
- Implantation in Muscle Test
- Implantation in Bone Test
Interactions with Blood Test (2 weeks)
- Hemolysis Test (ISO 10993-4 / GB)
- Hemolysis Test (ASTM F756)
- APTT、PT、TT、FIB (ISO 10993-4 / GB)
- Platelet Count Test
- Complement Test (ISO 10993-4 / GB)
- Thrombosis Test (in Vivo / in Vitro) (ISO 10993-4 / GB)
Genotoxicity Test (ISO 10993-3)
- Ames Test (8 weeks)
- Mouse Lymphoma Assay Test (10 weeks)
- Chromosome Aberration Test (10 weeks)
For more information about our Biocompatibility Testing services, please feel free to
contact us.
OTHER TESTING SERVICES