BIOCOMPATIBILITY
Product Categories
  • 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
 
Test Items and Standards
 
                   Test Item
      Standard
Lead Time 
 Cytotoxicity Test
Cytotoxicity Study (MTT Method)
ISO 10993-5
3 weeks
Cytotoxicity Study (Agarose Overlay Method)
ISO 10993-5 / USP 87
3 weeks
Cytotoxicity Study (Filter Diffusion Method)
ISO 10993-5
3 weeks
Cytotoxicity Study (Direct Contact Method)
ISO 10993-5 / USP 87
3 weeks
Cytotoxicity Study (MEM Method)
USP 87
3 weeks
Irritation and 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
Implantation in Subcutaneous Tissue Test 
ISO 10993-6
4 weeks at least
Implantation in Muscle Test 
ISO 10993-6
4 weeks at least
Implantation in Bone Test 
ISO 10993-6
4 weeks at least
Interactions with Blood Test
Hemolysis Test
ISO 10993-4 / GB
2 weeks
Hemolysis Test
ASTM F756
2 weeks
APTT、PT、TT、FIB
ISO 10993-4 / GB
2 weeks
Platelet Count Test
 
2 weeks
Complement Test
ISO 10993-4 / GB
2 weeks
Thrombosis Test (in Vivo / in Vitro)
ISO 10993-4 / GB
2 weeks
Genotoxicity Test
Ames Test
ISO 10993-3
8 weeks
Mouse Lymphoma Assay Test 
ISO 10993-3
10 weeks
Chromosome Aberration Test 
ISO 10993-3
10 weeks
Mouse Micronucleus Test
ISO 10993-3
10 weeks