Medical Device Irritation Testing

Medical Device Irritation Testing

Medical device irritation testing is a highly regulated industry (read more about medical device cleaning and validation) with requirements for cleaning, sterilization, reprocessing, and irritation testing. Similar to biocompatibility, irritation testing determines whether the material or the device itself will cause any irritation.

Medical device irritation testing is done to measure the reaction that a single exposure or repeated exposure to the device and its materials may have on the skin or inside the body. Irritation is characterized by inflammation, redness, swelling, heat, and/or pain.

Irritation testing is mandated by international standards and FDA regulations. Tests for irritation are done on the skin and mucous membranes (such as around the eye and nose) and determine the amount of exposure before irritation (if any) occurs.

Irritation can occur from chemicals in the device and its materials, some causing immediate reactions and others causing delayed reactions. ISO 10993-10 presents a four-tier approach to understanding and determining a device’s potential to cause irritation. First, manufacturers must determine whether there have been reports of irritation caused by the chemical or material in question. Second, find valid in vitro tests that identify irritation materials. If a material cannot be ruled out by steps one or two, the third step is to perform in vivo testing (either intracutaneous, primary skin, or ocular irritation) on the chemical or material to determine the irritation potential. Lastly, a noninvasive clinical study on people may need to be carried out.

Contract Laboratory has helped many manufacturers find third-party laboratories for their medical device testing, like the following:

• Large Corporation needs a Toxicology Laboratory for skin sensitization, skin irritation, and eye irritation studies (preferably according to OECD guidelines)
• Medical Device Laboratory needed for ISO testing of medical disposables to ISO 10993-5 Cytotoxicity and ISO 10993-10 Irritation Oral Stimulation and Bipolar Irritation Test (in vitro)
• Implantable Medical Device Manufacturer needs a Product Safety Toxicology Laboratory for in vivo irritation testing as per ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization.
• Medical Device Laboratory needed for bio-compatibility studies on whitened cotton textile products including cytotoxicity test and primary skin irritation test
• Medical Device Company needs 3rd party Product Safety Laboratory for Biocompatibility testing (cyto, irritation, sensitization)
• FDA GLP Medical Device Product Safety Laboratory needed for ISO 10993-1 biocompatibility studies for implantable bone graft substitutes (granules), xenograft (from bovine bone), and a biphasic calcium phosphate Cytotoxicity- Sensitization- Irritation or intracutaneous reactivity- Systemic toxicity- Subchronic toxicity- Genotoxicity- Implantation
• FDA cGMP Medical device laboratory needed for product safety and toxicology study testing of water-based personal lubricant including 1) Condom biocompatibility 2) Systemic toxicity 3) Vaginal irritation 4) Dermal sensitization
• FDA Product Safety laboratory is needed for toxicology studies of medical devices (ultrasound gel) for biocompatibility:  cytotoxicity, irritation / intracutaneous toxicity, and sensitization.
• FDA GLP Product Safety Laboratory is needed for Biocompatibility Testing for a medical device according to ISO 10993-1. Specifically Cytotoxicity testing (ISO 10993-5) and Irritation and Sensitization testing (ISO 10993-10).
• Medical Device laboratory needed for ASTM and ISO product safety testing for evaluation of medical devices including toxicology, packaging, and microbiology testing: ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms for compliance with latex and polyisoprene condoms. ISO 10993-5 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices-Part 10: Tests for irritation and skin sensitization ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity United States Pharmacopeia, National Formulary General Chapter <88>: Biological Reactivity Tests, In Vivo USP <51> Antimicrobial Effectiveness Testing USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms ISTA 3A: Packaged-Products for Parcel Delivery System Shipment 70 Kg (150 lb) or Less Shelf-life testing
• View more medical device test requests

NEED MEDICAL DEVICE TESTING OR RESEARCH STUDIES?

If you are a medical device manufacturer and need independent, third-party medical device laboratories to perform testing, visit our website to submit a medical device test request.