New York, USA – September 28, 2021 – STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, now launches medical device irritation testing service following the biocompatibility guidelines modified for medical devices. The testing is designed and performed based on the route of exposure to the body including the skin, mucosal, or ocular.
Irritation represents local tissue inflammation response to chemicals, without a systemic immunological component, and irritation is characterized by inflammation, redness, swelling, heat, or pain. Irritation testing is used to assess the potential of a medical device to cause an immediate irritation reaction in the skin, mucosal, or ocular tissues following a single or repeated exposure to the body. Irritation is one of the three most common biocompatibility tests required to ensure the safety of medical devices.
STEMart offers several methods as in vivo and in vitro assays for irritation biocompatibility testing, including the Topical Irritation Testing, and the Intracutaneous Reactivity Testing that is suitable for the detection of the potential for local irritation caused by chemicals extracted from a medical device. In the Topical Irritation Testing, the erythema and edema (redness and swelling) on the injection site are assessed after injection of extracts of the test material. It is suitable for the detection of the potential for local irritation caused by chemicals extracted from a biomaterial.
In addition, the Topical Irritation Testing also consists of several different testing methods, such as Oral Irritation, Vaginal Irritation, Nasal Irritation, Penile Irritation, Rectal Irritation, Skin Irritation Testing that measures cell viability in reconstructed human epidermis (RhE) tissues after a single chemical exposure, and Ocular Irritation Testing, a testing that is provided with several in vitro test methods for the identification of ocular irritation to satisfy the specific medical device requirements, including bovine corneal opacity and permeability (BCOP), the isolated chicken eye (ICE) test methods, Cytosensor microphysiometer (CM) test method, chorioallantoic membrane (HET-CAM) test method and isolated rabbit eye (IRE) test method.
STEMart offers comprehensive biocompatibility testing for both in vitro and in vivo assessments. With extensive expertise in biocompatibility testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks. “This new service is critical for STEMart to continue to assist the biopharma and medical device industry to accelerate the project to reach the next milestone. Customers can feel free to contact for this new medical device irritation testing service that enable users to push science forward.” said Tina Frederick, Executive Director of Marketing at STEMart.
If you have additional questions about medical device irritation testing service or would like to find out more about the medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform with an expanded global footprint and has a broad portfolio of more than 10,000 products. It aims to provide best-in-class lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage towards the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer, and through that to accelerate access to better health for people everywhere.