Toxicological evaluation of medical devices is required to establish the safety of medical devices used for implantation or in the delivery of drugs/fluids into humans. RCC has the capability to conduct tests for medical device/s listed below using different regulatory guidance’s such as ISO 10993, ASTM, Product specific ISO guidelines and Pharmacopoeia (USP/BP/IP).
Medical Devices Biocompatibility Testing
1.Cytotoxicity (GLP, ISO 10993-5): Cytotoxicity in vitro screening assays are a sensitive method to rapidly assess the biocompatibility of the test material (extract) when in contact with a specific cell culture
2.Sensitization (GLP, ISO 10993-10): Sensitization biocompatibility testing for medical devices is used to determine the allergic or sensitizing capacity to the repeated or prolonged exposure of a test material. Sensitization is characterized by delayed reactions that are not localized, independent of dose.
- Local lymph node assay (LLNA)
- Contact Hypersensitivity- GPMT - (Guinea Pig Maximization Test, Magnusson and Kligman Method & Buehler Test Method)
3.Irritation or intracutaneous reactivity (GLP, ISO 10993-10): Irritation biocompatibility testing consists of in vivo screens that evaluate the potential of test materials – or their extracts – to cause irritation on the exposed part of the body. Standard studies are single-exposure evaluations. Based on clinical product use, studies may be customized for evaluation of repeat exposures.
- Dermal Irritation or Primary Skin Irritation
- Intracutaneous Reactivity
- Ocular Irritation
- Mucosa Irritation(Rectal, Vaginal, Penile)
4.Pyrogenicity Test: Pyrogen test in rabbits (GLP, ISO 10993-11): Bacterial endotoxin testing or rabbit material-mediated pyrogen-testing detects endotoxin on the biomaterial surface and any related pyrogen reaction via endotoxin contamination with a known specified toxin limit.
- In vitro Bacterial Endotoxins
- Material Mediated Rabbit Pyrogen Test
5.Genotoxicity Test (OECD GLP, ISO 10993-03)
- Bacterial Reverse Mutation Test (Ames)
- In vitro Mouse Lymphoma Assay
- In vitro & In vivo Micronucleus Test
- In vitro Chromosomal Aberration Test
6.Systemic Toxicology(OECD GLP, ISO 10993-11): Acute and repeated exposure, available with a wide range of dose routes in appropriate species
7.Hemocompatibility: For devices in direct contact with circulating blood (regardless of contact duration) hemocompatibility tests are performed to evaluate the effects of blood-contacting medical devices. Hemolysis determines the degree of erythrocyte (red blood cell) lysis and the release of hemoglobin caused by medical devices.
- Prothrombin Time Assay (PT)
- Activated Partial Thromboplastin Time Assay(APTT)
8.Carcinogenicity and Reproductive toxicity: Carcinogenicity and reproductive toxicity testing is rarely required for medical devices. RCC has the experience and capability to perform both these studies under GLP conditions.
9.Others: RCC also offers biocompatibility test for plastics (USP Class VI test)
