Biocompatibility Testing of Medical Devices
Services
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