What is ISO10993-23 testing?
Skin irritation testing is essential for demonstrating that a medical device does not cause adverse local effects following contact with the body. ISO 10993-23 is a regulatory requirement for devices that contact intact or compromised skin, which is re-enforced in the ISO 10993-1.
Reconstructed human epidermis (RhE) consists of human skin cells which are organised into a normal human epidermis 3D structure. The adoption of in RhE models allows manufacturers to assess irritation potential without animal testing. This supports ethical product development, reduces testing timelines, and aligns with global regulatory expectations to replace, reduce, and refine animal use, while still generating relevant data for regulatory submissions.
ISO 10993-23 irritation testing evaluates whether exposure to a device or its extracts reduces skin cell viability to a level indicative of irritation. A test item is considered to have irritant potential if the skin cell viability falls below 50% compared to the negative control.
Skin irritation testing is applicable to medical devices and materials that have surface or external contact with the body, including:
• Wound dressings and plasters
• Wearable and adhesive medical devices
• Topical devices, gels, creams, and liquids
• Catheters and tubing with skin contact
• Raw materials and finished devices intended for dermal exposure
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 requirementsISO 10993-23 Test for Irritation
We 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.
Frequently Asked Questions
How long does Skin irritation testing take?
Medical devices require a 72 hour incubation period for this test, a typical skin irritation test is performed within 6 days. At test Labs we ensure that pre-liminary results are notified on the same week of the results.
How should I prepare my device for Irritation testing?
Devices should be provided in their final finished state, including any coatings, additives, or sterilisation processes. Samples must be clean, unused, and representative of the marketed product.
What information about my device is required for Irritation testing?
As our testing is compliant with the principles of GLP, alongside the test item we would need further information on the production of the device such as; manufacturer name, adress and date, manufacturing methods e.g. sterilisation processes and moulding processes, as well as surface areas and dimensions of test items.
Does skin irritation testing require animals?
No, this test uses commercially available 3D models from human skin cells, hence the rapid turnover in testing time.
What are RhE models?
Reconstructed human epidermis (RhE) are models that consist 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.
We won’t keep you waiting
We respond to all enquiries within minutes of receiving them.
Our lead times match the urgency and demand in the market – we offer industry-leading turnaround times because we know how critical reliable data is for your project. While what you’ve seen is our typical lead time, the final timeline will depend on your specific study requirements. But rest assured, we’ll do everything we can to deliver even faster.
Think of it like a relay race – we’ll hand over the data baton as quickly as possible, so you can keep moving forward on your medical device journey.