BIOCOMPATIBILITY

 

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
  • 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 

 

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.