Medical Devices

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
  • MTT assay

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)