Biocompatibility
Crystal Biological solutions is committed to quality of work for medical devices for its biocompatibility as per ISO, US FDA guidelines for regulatory approvals.
Biocompatibility Testing of Medical Devices:
Test for in vitro Cytotoxicity (ISO 10993-5)
- MEM Elution
- Agar Overlay Assays
- Direct Contact Test
- MTT Test
- XTT Assay
- Neutral Red Uptake (NRU)
- Colny Formation
Skin Irritation (ISO 10993-10)
- Primary Skin Irritation Test
- Intracutaneous Reactivity
- Dermal Irritation Test
- Mucosal Irritation (vaginal, rectal, oral, penile, ocular)
Skin Sensitization (ISO 10993-10)
- Buehler Sensitization Method
- Guinea Pig Maximisation Test
- Local Lymph Node Assay (LLNA)
Genotoxicity (ISO 10993-3/33)
- Bacterial Reverse Mutation (AMES) Test
- Cell Gene Mutation Test (Mouse Lymphoma Assay)
- In vitro & In vivo Micronucleus Test
- In vitro & In vivo Chromosomal Aberration
Hemocompatibility (ISO 10993-4)
- Hemolysis Test
- Partial Thromboplastin Time
- Complement Activation
- Platelet Aggregation /Activation
- Platelet Aggregation /Activation
Pyrogenicity (USP, ISO 10993-11)
- In vitro Bacterial Endotoxins
- Material Mediated Pyrogenicity Test
Haematology Test
Implantation Studies (ISO 10993-6)
- Intramuscular
- Subcutaneous
- Bone
- Brain
Systemic Toxicity (ISO 10993-11)
- Acute
- Sub-acute
- Sub-chronic
- Chronic
Biocompatibility
Previous
Next
