Topical Irritation Testing

A big variety of chemical components such as starting materials and processing aids including lubricants and mould-release agents used in the manufacture of medical device, adhesive/solvent residues from assembly process, and sterilant residues from sterilization process may be present in a finished product. It shall be taken into consideration that whether these components have the potential irritation activity. Irritation is characterized by inflammation, redness, swelling, heat, and/or pain.

STEMart provides a wide range of in vitro and in vivo Topical Irritation Tesing according to the biocompatibility guidelines modified for medical devices.

Standard of Topical Irritation Testing

• ISO 10993-10: 2010

Topical Irritation Testing Capabilities

• In Vitro Skin Irritation Test

In vitro skin irritation test with reconstructed human epidermis (RhE) model measures the cytotoxic effects of medical device extract to predict the acute skin irritation of device.

• Ocular Irritation Test

Both in vitro and in vivo ocular irritation tests are provided to assess the potential of medical device to product ocular irritation.

• In vitro ocular irritation tests

Bovine corneal opacity and permeability (BCOP) test;

Isolated chicken eye (ICE) test;

Cytosensor microphysiometer (CM) test;

Chorioallantoic membrane (HET-CAM) test;

Isolated rabbit eye (IRE) test.

• In vivo ocular irritation test
• Oral Irritation Test

In vivo oral irritation test is provided to assess the potential of medical device with intended contact with oral tissue to produce irritation of the oral tissue.

• Vaginal Irritation Test

In vivo vaginal irritation test is provided to assess the potential of medical device with intended contact with vaginal tissue to produce irritation of the vaginal tissue.

• Penile Irritation Test

In vivo penile irritation test is provided to assess the potential of medical device with intended contact with penile tissue to produce irritation of the penile tissue.

• Rectal Irritation Test

In vivo rectal irritation test is provided to assess the potential of medical device with intended contact with rectal tissue to produce irritation of the rectal tissue.

If you have additional questions about Topical Irritation Testing or would like to find out more about our services, please feel free to contact us.

Reference

• International Organization for Standardization. Biological evaluation of medical devices — Part 10: Selection of tests for interactions with blood. ISO 10993-10; (2010).