Updated: 27th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is In Vitro Skin Irritation Testing?
In vitro skin irritation testing is one of the biological assessments used during the Biological Evaluation of medical devices to determine whether a device, its constituent materials or chemical extracts have the potential to cause reversible irritation following contact with the skin. As one of the biological endpoints identified within ISO 10993-1, skin irritation testing provides important evidence to demonstrate that a medical device is biologically safe for its intended clinical use.
The internationally recognised requirements for in vitro skin irritation testing are defined within ISO 10993-23, which describes validated laboratory methods using reconstructed human epidermis (RHE) models to assess the irritation potential of medical device materials and extracts. These modern methods replace many historical animal-based approaches while providing clinically relevant data to support regulatory submissions under the EU Medical Device Regulation (EU MDR 2017/745) and other international regulatory frameworks.
However, ISO 10993-1:2025 reinforces that skin irritation testing should not be performed routinely for every medical device. Instead, manufacturers are expected to undertake a risk-based Biological Evaluation, considering factors such as the nature of body contact, contact duration, material composition, chemical characterisation, manufacturing processes, toxicological risk assessment and existing biological evidence before determining whether additional laboratory testing is scientifically justified.
This guide explains when in vitro skin irritation testing may be required, how the ISO 10993-23 test methods work, how results are interpreted and how skin irritation testing fits within the wider Biological Evaluation process for medical devices.
Need an Introduction to Biological Evaluation?
This article focuses on in vitro skin irritation testing under ISO 10993-23. If you're looking for a complete overview of biological evaluation, including ISO 10993, biological risk assessment, BEPs, BERs, chemical characterisation, toxicological assessment and risk-based testing, read our Complete Guide to Biological Evaluation of Medical Devices.
The Importance of Skin Irritation
Skin irritation occurs when a substance causes inflammation or damage to the skin upon contact. For medical devices, this can be a serious concern, as they are often in prolonged contact with the skin. The consequences of not adequately testing for irritation can range from minor redness to severe dermatitis, leading to discomfort, injury, or even infection in users. Therefore, reliable testing methods are crucial to ensure that products are safe before they reach the market.
What’s Changed in ISO 10993-1:2025?
Skin irritation testing should always be selected as part of a risk-based Biological Evaluation rather than performed routinely. Learn how ISO 10993-1:2025 strengthens the emphasis on scientific justification, chemical characterisation, toxicological risk assessment and lifecycle evidence in our Guide to ISO 10993-1:2025.
The Evolution of Testing Methods
Traditionally, skin irritation testing was performed on animals, typically rabbits, to assess the potential harm that a product could cause to human skin. However, the ethical implications of animal testing, coupled with the drive for more human-relevant and scientifically advanced methods, have led to the development of alternative approaches. In vitro testing has emerged as a viable and accepted method, offering several advantages, including reduced ethical concerns, cost-effectiveness, and improved reproducibility of results.
How In Vitro Skin Irritation Testing Is Performed
ISO 10993-23 describes validated in vitro methods for assessing the skin irritation potential of medical devices using reconstructed human epidermis (RHE) models. These laboratory models closely replicate many of the structural and functional characteristics of human skin, allowing manufacturers to evaluate irritation potential without relying on traditional animal testing.
The assessment typically involves four key stages: preparing device extracts, exposing the reconstructed skin model, measuring cell viability using the MTT assay and interpreting the results against defined acceptance criteria.
Reconstructed Human Epidermis (RHE) Models
Reconstructed Human Epidermis (RHE) models are laboratory-grown, three-dimensional human skin tissues developed from cultured human keratinocytes. These models reproduce many of the characteristics of the outer layers of human skin, including a differentiated epidermis and functional barrier properties, making them suitable for evaluating the irritation potential of chemicals and medical device extracts.
During testing, the prepared device extract is applied directly to the surface of the reconstructed skin tissue for a specified exposure period. Following incubation, the tissue is rinsed and allowed to recover before cell viability is assessed using the MTT assay.
Advantages
- Closely replicates the biological behaviour of human epidermis.
- Eliminates the need for many historical animal irritation tests.
- Provides reproducible and internationally recognised test results.
- Accepted by regulators for demonstrating skin irritation potential under ISO 10993-23.
Limitations
- Assesses irritation only and does not evaluate skin sensitisation.
- May not fully represent complex clinical exposure conditions.
- Results should always be interpreted alongside chemical characterisation, toxicological assessment and the wider Biological Evaluation.
Extract Preparation
Before exposure to the reconstructed skin model, medical devices are typically extracted using appropriate extraction media to recover substances that could potentially migrate from the device during clinical use. The extraction process is designed to simulate the release of chemicals that patients may be exposed to under normal conditions of use.
Depending on the nature of the device and its constituent materials, laboratories may prepare:
- Polar extracts, using aqueous or physiological media to recover water-soluble substances.
- Non-polar extracts, using suitable organic extraction media to recover hydrophobic compounds that may not dissolve in water.
Extraction conditions, including the extraction ratio (surface area or mass of device per volume of extraction medium), extraction temperature and extraction duration, are defined within the ISO 10993 series to ensure consistent and reproducible testing.
Appropriate extract preparation is essential because poorly prepared extracts may underestimate or overestimate the potential biological hazards associated with the device.
Measuring Cell Viability Using the MTT Assay
Following exposure of the reconstructed human epidermis to the prepared extracts, tissue viability is determined using the MTT assay, one of the most widely used laboratory methods for measuring living cells.
The MTT assay works by measuring mitochondrial metabolic activity. Viable cells contain active mitochondrial enzymes that convert the yellow MTT reagent into an insoluble purple compound known as formazan. The amount of purple colour produced is directly proportional to the number of living cells remaining after exposure to the test material.
After the formazan crystals are dissolved, the intensity of the colour is measured using a spectrophotometer. The measured absorbance is compared with untreated control tissues to calculate the percentage cell viability.
Interpretation of Results
The measured cell viability is compared with the acceptance criteria specified in ISO 10993-23 and the validated test method.
- High cell viability indicates that the device extract is non-irritant under the conditions of the test.
- Reduced cell viability below the defined acceptance threshold indicates that the extract demonstrates skin irritation potential and should be investigated further as part of the Biological Evaluation.
A skin irritation result should never be interpreted in isolation. Manufacturers should consider the findings alongside chemical characterisation, extractables and leachables studies, toxicological risk assessments, clinical evidence and all other available biological data before drawing conclusions regarding the biological safety of the medical device.
Summary of the ISO 10993-23 Testing Process
| Stage | Purpose |
|---|---|
| Extract Preparation | Recover potentially irritating substances from the medical device using appropriate extraction media before biological assessment. |
| Reconstructed Human Epidermis (RHE) Exposure | Expose a laboratory-grown human skin model to the prepared extracts to evaluate the potential for skin irritation. |
| MTT Assay | Measure mitochondrial activity and cell viability by quantifying the conversion of MTT to purple formazan within living cells. |
| Interpretation of Results | Compare cell viability with the acceptance criteria to determine whether the device extract demonstrates skin irritation potential and assess the findings within the wider Biological Evaluation. |
What Does a Skin Irritation Test Failure Mean?
A skin irritation test result should never be interpreted in isolation. A positive result indicates that, under the conditions of the test, the medical device or its extract has demonstrated the potential to cause reversible skin irritation. However, this does not automatically mean that the device is unsafe, non-compliant or cannot achieve regulatory approval.
Skin irritation responses may arise for a variety of reasons, including residual manufacturing chemicals, processing aids, sterilisation residues, cleaning agents, material degradation products or substances identified during extractables and leachables (E&L) studies. In some cases, the observed response reflects the conservative nature of the laboratory test or the extraction conditions used rather than the actual biological risk presented during normal clinical use.
Where an irritation response is identified, manufacturers should investigate the underlying cause as part of the wider Biological Evaluation. This investigation may include reviewing the material composition, manufacturing processes, supplier information, chemical characterisation data, extractables and leachables studies, toxicological risk assessments and any available clinical or post-market evidence. If necessary, manufacturers may also implement process improvements, material changes or additional biological testing to address any remaining uncertainties.
The outcome of this investigation should be documented within the Biological Evaluation Report (BER). Rather than relying solely on the skin irritation test result, the BER should evaluate all available biological evidence and explain whether the identified irritation risk has been adequately characterised, controlled or mitigated. Only after considering the complete body of evidence should conclusions be drawn regarding the biological safety of the medical device.
Ultimately, ISO 10993-1:2025 requires manufacturers to adopt a risk-based approach to Biological Evaluation. Skin irritation testing represents only one biological endpoint, and its results should always be interpreted alongside chemical characterisation, toxicological assessment, risk management under ISO 14971, clinical evidence and Post-Market Surveillance before determining whether a device is biologically safe for its intended clinical use.
Key Takeaway
A positive skin irritation test does not automatically mean a medical device is unsafe. ISO 10993-1:2025 requires manufacturers to investigate the underlying cause, evaluate all available biological evidence and document a scientifically justified conclusion within the Biological Evaluation Report (BER) before determining the device’s biological safety.
Worked Example: Selecting Skin Irritation Testing as Part of a Biological Evaluation
A manufacturer has developed a single-use wearable ECG electrode intended for continuous contact with intact skin for up to seven days. During the Biological Evaluation, the device is categorised according to its nature of body contact and contact duration in accordance with ISO 10993-1:2025. A Biological Evaluation Plan (BEP) is then developed to identify the biological endpoints requiring assessment.
The manufacturer first reviews the material specifications, supplier information, existing clinical evidence and published literature relating to the adhesive, backing material and conductive gel. Chemical characterisation and a toxicological risk assessment are then performed to identify any substances that could potentially migrate from the device during normal clinical use.
Although the individual materials have an established history of safe use, the Biological Evaluation identifies an evidence gap because a new skin adhesive formulation has been introduced during product development. As a result, skin irritation is identified as a relevant biological endpoint requiring further investigation.
An ISO 10993-23 in vitro skin irritation test is performed using a validated reconstructed human epidermis (RHE) model. The prepared device extracts are applied to the tissue model and cell viability is measured using the MTT assay. The study demonstrates that tissue viability remains above the acceptance threshold, indicating that the device extract is non-irritant under the conditions of the test.
The results are incorporated into the Biological Evaluation Report (BER) together with the chemical characterisation, toxicological assessment and supporting scientific evidence. Based on the complete Biological Evaluation, the manufacturer concludes that the wearable ECG electrode is biologically safe for its intended clinical use and that no further skin irritation testing is required at this stage.
This example demonstrates the risk-based philosophy of ISO 10993-1:2025. Skin irritation testing is performed only after the Biological Evaluation identifies a scientifically justified evidence gap, rather than being undertaken as a routine requirement for every medical device.
The Impact on Product Development
Adopting ISO 10993-23 in product development offers several benefits:
Ethical Compliance
The adoption of validated in vitro methods also enables manufacturers to demonstrate their commitment to ethical and scientifically robust product development by reducing reliance on animal testing. ISO 10993-23 promotes the use of reconstructed human epidermis (RHE) models that support the internationally recognised 3Rs principles (Replacement, Reduction and Refinement) while generating reproducible data suitable for regulatory decision-making. As regulatory science continues to evolve, competent authorities increasingly encourage the use of validated non-animal methods where they provide an equivalent or improved assessment of biological safety, helping manufacturers meet both ethical expectations and regulatory requirements.
Regulatory Acceptance
Compliance with ISO 10993-23 helps manufacturers generate internationally recognised evidence demonstrating that a medical device does not present an unacceptable risk of skin irritation for its intended clinical use. The standard provides validated test methods that are widely accepted by regulatory authorities and Notified Bodies as part of a risk-based Biological Evaluation under ISO 10993-1. By following these recognised methods and documenting the results within the Biological Evaluation Report (BER), manufacturers can strengthen their Technical Documentation, support conformity assessment under the EU Medical Device Regulation (EU MDR 2017/745) and facilitate more efficient regulatory submissions across multiple international markets. This harmonised approach also promotes consistency in biological safety assessments, helping manufacturers demonstrate compliance while reducing uncertainty during regulatory review.
Cost and Time Efficiency
In addition to reducing the use of animal testing, validated in vitro methods can significantly improve the efficiency of product development. Compared with traditional animal studies, in vitro skin irritation testing can often be completed more quickly, providing manufacturers with earlier feedback during material selection, design verification and product development. This enables potential biological risks to be identified and addressed before more costly stages of development or regulatory submission. When integrated into a risk-based Biological Evaluation, faster access to reliable biological data can reduce project timelines, support informed design decisions and minimise delays associated with product modifications. These advantages are particularly valuable in highly regulated industries such as medical devices, where manufacturers must balance innovation with robust evidence demonstrating biological safety and regulatory compliance.
Enhanced Safety
By following the requirements of ISO 10993-23, manufacturers can generate robust scientific evidence demonstrating that a medical device does not present an unacceptable risk of skin irritation for its intended clinical use. When combined with chemical characterisation, toxicological risk assessment, clinical evidence and the wider Biological Evaluation required by ISO 10993-1, skin irritation testing helps identify and control potential biological hazards before products are placed on the market. This proactive, risk-based approach not only supports compliance with international regulatory requirements but also reduces the likelihood of adverse patient reactions, post-market complaints, corrective actions and product recalls. By identifying potential issues early in the product development lifecycle, manufacturers can make informed design and material selection decisions, strengthen their Technical Documentation and demonstrate to regulators and Notified Bodies that biological safety has been systematically evaluated and appropriately managed.
Challenges and Considerations
While ISO 10993-23 offers a robust framework for in vitro skin irritation testing, there are challenges and considerations to keep in mind:
Technical Expertise:
Conducting in vitro skin irritation testing requires specialised scientific expertise, validated laboratory procedures and appropriately trained personnel. Testing laboratories must operate under robust quality systems and use validated reconstructed human epidermis (RHE) models, calibrated analytical equipment and standardised protocols to ensure that results are accurate, reproducible and scientifically reliable. In addition to performing the laboratory procedures, experienced scientists must prepare appropriate device extracts, select suitable extraction conditions, conduct the MTT assay correctly and interpret the results within the context of the wider Biological Evaluation. The final assessment should not rely solely on the laboratory outcome but should also consider chemical characterisation, toxicological risk assessments, clinical evidence and the intended clinical use of the medical device. This multidisciplinary approach helps ensure that skin irritation testing provides meaningful evidence to support regulatory submissions and informed biological safety decisions.
Interpretation of Results:
Although ISO 10993-23 defines validated test methods and acceptance criteria for assessing skin irritation potential, interpreting the results can still require considerable scientific and regulatory expertise. A reduced cell viability result does not automatically mean that a medical device is unsafe or unsuitable for clinical use. Instead, manufacturers must evaluate the findings alongside the complete body of biological evidence, considering factors such as the device’s intended purpose, nature and duration of body contact, material composition, manufacturing processes, chemical characterisation, extractables and leachables (E&L) data, toxicological risk assessments and any available clinical or post-market evidence. Where unexpected or borderline results are obtained, further investigation may be required to identify the underlying cause, determine whether additional testing is justified or assess whether design or manufacturing changes are necessary. The final conclusions should be documented within the Biological Evaluation Report (BER), demonstrating that the irritation risk has been scientifically evaluated and remains acceptable for the device’s intended clinical use as part of the wider risk management process described in ISO 10993-1 and ISO 14971.
Limitations of In Vitro Models:
Although reconstructed human epidermis (RHE) models provide a scientifically robust and internationally accepted method for assessing skin irritation potential, no single laboratory test can fully replicate the complexity of human biology or every possible clinical use scenario. The biological response to a medical device is influenced by numerous factors, including material composition, manufacturing processes, chemical release, duration of contact, patient population and the intended conditions of use. For this reason, ISO 10993-23 should be applied as one component of a wider risk-based Biological Evaluation rather than as a standalone assessment. Where uncertainty remains following testing, manufacturers should consider all available evidence, including chemical characterisation, extractables and leachables (E&L) studies, toxicological risk assessments, clinical experience, post-market surveillance data and other relevant biological endpoints before determining whether further investigations are scientifically justified. This weight-of-evidence approach, as described in ISO 10993-1:2025, helps ensure that conclusions regarding skin irritation are based on the complete biological safety profile of the medical device rather than the outcome of a single test.
Conclusion
In vitro skin irritation testing remains an essential component of the Biological Evaluation of medical devices, providing scientifically robust evidence on whether a device, its materials or chemical extracts have the potential to cause skin irritation following patient contact. Performed in accordance with ISO 10993-23, these validated non-animal methods enable manufacturers to assess irritation potential using reconstructed human epidermis (RHE) models, supporting both patient safety and the principles of ethical product development.
However, as reinforced by ISO 10993-1:2025, skin irritation testing should not be viewed as a routine or standalone requirement. Instead, it should form part of a comprehensive, risk-based Biological Evaluation that considers device categorisation, intended clinical use, material composition, chemical characterisation, toxicological risk assessment, clinical evidence and all other available biological data before determining whether laboratory testing is scientifically justified.
By integrating ISO 10993-23 testing into a well-documented Biological Evaluation Plan (BEP), Biological Evaluation Report (BER) and wider ISO 14971 risk management process, manufacturers can generate internationally recognised evidence demonstrating that biological risks have been systematically identified, evaluated and controlled. This evidence not only supports compliance with the EU Medical Device Regulation (EU MDR 2017/745) and other international regulatory frameworks but also helps ensure that medical devices are biologically safe for their intended clinical use throughout the product lifecycle.
Learn More About Cytotoxicity Testing
Skin irritation is only one biological endpoint considered during a Biological Evaluation. Learn how ISO 10993-5 cytotoxicity testing assesses whether medical device materials or extracts can damage living cells, how the principal test methods differ and how results should be interpreted in our Complete Guide to Cytotoxicity Testing.
Why Does Chemical Characterisation Matter?
Chemical characterisation can help identify substances that may contribute to an irritation response and determine whether additional biological testing is required. Learn how extractables and leachables studies support toxicological risk assessment and Biological Evaluation in our Complete Guide to Extractables & Leachables Testing.
Developing a Drug-Contacting Medical Device?
For syringes, infusion sets, administration bags and other drug-contacting devices, biological safety may also depend on the stability and compatibility of the medicinal product. Learn how material interactions, leachables and storage conditions can affect drug quality in our Guide to Drug Stability in Medical Devices.
When Is Skin Irritation Testing Actually Required?
Not every skin-contacting medical device automatically requires new irritation testing. Discover how manufacturers use device categorisation, existing evidence, chemical characterisation, toxicological assessment and biological risk analysis to determine whether testing is scientifically justified in our Guide to When Biocompatibility Testing Is Required.
Frequently Asked Questions About In Vitro Skin Irritation Testing
In vitro skin irritation testing assesses whether a medical device or its materials can cause irritation to the skin without the need for animal testing. It uses human-derived skin models or reconstructed human epidermis (RHE) to predict potential irritant effects.
Why it matters: This testing is a regulatory requirement under ISO 10993-23, ensuring that medical devices are safe for skin contact while supporting ethical testing practices.
ISO 10993-23 is the standard that specifies methods for evaluating skin irritation caused by medical devices or their components. It replaced the in vivo rabbit irritation test with scientifically validated in vitro methods, aligning with the move toward animal-free testing.
Key insight: Compliance with ISO 10993-23 is mandatory for medical devices in contact with intact skin to meet regulatory approval in the EU, UK, and other markets.
The testing involves:
- Extract Preparation: Device materials are extracted using simulated biological fluids.
- Exposure to RHE Models: The extracts are applied to RHE models, which mimic human skin.
- Measurement of Cellular Response: After a set exposure time, cell viability is measured using assays like MTT (a colorimetric test).
- Data Interpretation: Results are analyzed to determine if the product causes skin irritation.
Pro tip: Proper extraction procedures and controls are essential for reliable results.
Devices requiring this test include:
- Wearable devices: Such as adhesive patches and ECG electrodes.
- Surgical dressings: Products intended for prolonged skin contact.
- Protective gear: Masks, gloves, or gowns in direct contact with the skin.
- Implant delivery systems: If they come into contact with intact skin during application.
Key takeaway: Any device intended for skin contact must be evaluated for irritation risks as part of biological safety testing.
- In Vitro Skin Irritation Testing: Focuses specifically on skin irritation responses using human skin models.
- Cytotoxicity Testing: Evaluates the general toxicity of materials on cells without targeting specific tissues like skin.
Key insight: While cytotoxicity testing is broader, irritation testing is tissue-specific and essential for skin-contact devices.
Yes! Patient Guard offers comprehensive support for biological evaluation, including:
- Assisting with testing strategy development.
- Coordinating in vitro skin irritation testing with accredited labs.
- Reviewing results for regulatory submission.
- Preparing Biological Evaluation Reports (BER) that comply with ISO 10993 standards.
Why choose Patient Guard: With expertise in ISO 10993 and regulatory compliance, we help ensure your device meets safety requirements efficiently and ethically.
References
This guide is based on the following legislation, international standards and official regulatory guidance relating to in vitro skin irritation testing and the Biological Evaluation of medical devices.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Requires manufacturers to demonstrate compliance with the General Safety and Performance Requirements, including the identification, evaluation and control of biological risks associated with patient-contacting medical devices. |
| International Organization for Standardization (ISO) | ISO 10993-23:2021 – Biological Evaluation of Medical Devices – Part 23: Tests for Irritation | Specifies internationally recognised methods for evaluating the irritation potential of medical devices, their materials and extracts. It includes in vitro testing using reconstructed human epidermis models and supports the assessment of irritation as part of a wider Biological Evaluation. |
| International Organization for Standardization (ISO) | ISO 10993-1:2025 – Biological Evaluation of Medical Devices – Part 1: Requirements and General Principles for the Evaluation of Biological Safety Within a Risk Management Process | Provides the overarching risk-based framework for Biological Evaluation and explains how manufacturers determine whether irritation and other biological endpoints require further assessment based on device categorisation, patient contact, materials, existing evidence and identified biological risks. |
| International Organization for Standardization (ISO) | ISO 10993-12:2021 – Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials | Provides requirements and guidance for selecting test samples, preparing medical device extracts, choosing appropriate extraction media and establishing extraction ratios and conditions for biological testing. |
| International Organization for Standardization (ISO) | ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | Provides the internationally recognised risk management framework used to identify, evaluate, control and monitor biological hazards, including potential irritation risks, throughout the medical device lifecycle. |
| U.S. Food and Drug Administration (FDA) | Biocompatibility Evaluation Endpoints by Device Category | Provides endpoint tables showing when irritation or intracutaneous reactivity should be considered according to device category, body-contact type and contact duration. |
| U.S. Food and Drug Administration (FDA) | Basics of Biocompatibility: Information Needed for Assessment by the FDA | Explains the FDA's risk-based approach to medical device biocompatibility, including the importance of evaluating the finished device, its materials, manufacturing processes, sterilisation, intended anatomical contact and exposure duration. |
Skin irritation testing should be undertaken as part of a documented, risk-based Biological Evaluation rather than treated as a routine standalone test. Manufacturers should consult the latest published legislation, recognised international standards and official regulatory guidance when determining whether irritation testing is scientifically justified, selecting appropriate extraction and test methods and interpreting the results within the Biological Evaluation Report.
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