ISO 10993-23 Test for Irritation

We offer ISO 10993-23 tests to determine irritation potential of their devices without the need for animal testing

What is ISO10993-23 testing?

Tests to determine the irritancy of medical devices, materials or their extracts. Irritation testing is essential in evaluating a device’s potential to cause an irritation reaction following exposure to the body. With the introduction of the In Vitro Recombinant human Epidermis (RhE) model for skin irritation, manufacturers can now look to determine irritation potential of their devices without the need for animal testing.

The testing allows for detection of irritants from polar and non-polar extracts of devices as well as through direct contact with compatible creams, liquids and gels. The test method determines the viability of the RhE cells, with <50% viability as an indication of irritant potential. Reconstructed human epidermis (RhE) consists of human skin cells (keratinocytes) which are organised into a normal human epidermis structure, forming a 3D structure.

These models overcome the limitations of traditional monolayer of cells which are used in cytotoxicity in vitro testing, as they represent more of the complex systems that occur in organisms. The RhE 3D structure includes an organized basal, spinous, and granular layer, as well as multi-layered stratum corneum (the outer layer of skin which acts as the main skin barrier).

Biological Evaluation Plan

BEP establishes your product testing requirements. It also helps to prevent unnecessary testing studies.

ISO 10993-23 Test for Irritation

The test extract is topically exposed to the RhE skin tissue and incubated. The sample is exposed to MTT dye, which is a yellow salt that measures cellular metabolic activity.

Biological Evaluation Report

Your report will be issued with in two weeks of experimental phase completion, fully compliant with GLP requirements

Test Labs Limited perform regulatory studies in compliance with the Principles of Good Laboratory Practice (GLP). GLP is a defined set of Principles designed to be implemented within a quality system of a test facility conducti ng non-clinical health and environmental safety studies intended for regulatory submission. These principles outline how studies should be planned, performed, monitored, recorded, archived, and reported with the aim to harmonise the way in which test facilities work. The GLP Principles were published for test facilities to comply with to ensure the integrity, quality, consistency, and reliability of data that is produced.

The GLP regulations require that “regulatory studies” to demonstrate the safety or properties where the data is intended for submission must be performed at a test facility that is a member of the respective national compliance monitoring programme. As a member of this programme test facilities are inspected on a regular basis as an assessment of conformity.

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In vitro means ‘in glass’ which essentially refers to testing that occurs in glass vessels, instead of in a human or animal

A Guide to Good Laboratory Practice (GLP): Everything You Need to Know

GLP is a defined set of principles to be implemented in a QMS by an organisation completing non-clinical studies

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Clinical Evaluation

We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.

Medical devices bioburden testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

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Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

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We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

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Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials

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