Biocompatibility Testing

IIRT performs biocompatibility testing to evaluate the appropriate use of component material or finished product. Our Biocompatibility test results are widely acknowledged and trusted. Biocompatibility tests are performed in a safe and secure environment considering all the necessary measures. 

Various safety evaluation studies are conducted on biomaterials, medical devices, and related products to identify the presence of toxins or any other harmful components. Biocompatibility testing needs to meet FDA and international standards and for that variety of tests are done which range from the initial screening of new materials to product release testing, periodic audit testing, and non-clinical or pre-market safety evaluations. We assure to use all the safety measures and follow all three major steps which include planning, testing, and evaluating the data.

IIRT undertakes the Biocompatibility safety assessment of medical devices as per ISO/FDA for the following tests/categories.

• Phys-chem studies
• Implantation Studies
• Irritation and Hypersensitivity
• Systemic Toxicity
• Cytotoxicity and Genotoxicity
• Immunotoxicity
• Toxicokinetics

Our team of experts discuss with you the needs and after a thorough understanding of the same advise the best testing plans that are the right choice of biocompatibility testing for your product.

The three common/general biocompatibility tests that each device needs to go for include:

• Cytotoxicity
• Sensitization
• Irritation test

Biocompatibility Studies for Medical Devices under ISO 10993
Cytotoxicity	Implantation   Testing	Genotoxicity	Irritation	Systemic   Toxicity
Agar overlay		AMES test	Intracutaneous   Reactivity	Acute, Sub-   acute, and   Pyrogen test
MEM Elution	Intramuscular   (USP/ISO)   and   subcutaneous   Implantation	Mouse   Lymphoma	Dermal    Irritation
Direct   contact		In vitro and     In vivo   micronucleus	Ocular Irritation	Sub-chronic   and Chronic
MTT assay		Chromosome    Aberration	Mucosa   Irritation
Colony   Formation			(Oral, Rectal,   Vaginal,   Penile)	Reproduction   toxicity

 

 

Sensitization	Systemic   Toxicity	Hemo-   compatibility	USP Plastics
Maximization   Test	Acute, Sub-   acute, and   Pyrogen test	ASTM Hemolysis   tests – Direct and   Indirect contact	USP I-IV
Closed Patch   (Buehler)			Systemic   injection
Local lymph   node assay	Sub-chronic     and Chronic		Intracutaneous   test
	Reproduction   toxicity		Implant test

 

 

 

 

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