Contact of medical devices with the human body carries various biological risks. Particularly for products that come into direct or indirect contact with skin, eyes, or mucous membranes, the risk of irritation must be thoroughly assessed. One of the fundamental sources ensuring the scientific and international standardization of this process is the standard EN ISO 10993-23.
What is an Irritation Test?
The irritation test is one of the biocompatibility tests used to determine whether a medical device or its component has an irritating effect on living tissue. Depending on the product's application area and contact duration, the risk of irritation to the skin, eyes, or mucous membranes is assessed.
What does EN ISO 10993-23 encompass?
EN ISO 10993-23 is the part of the ISO 10993 series on biocompatibility that addresses irritation assessment. This standard specifies the test methods and requirements to be applied for determining the irritation potential of medical devices.
Scope of Contact Areas:
- Skin (dermal irritation)
- Eyes (ocular irritation)
- Mucous Membranes (oral, vaginal, rectal areas)
How is the Test Performed?
- Extract Preparation: Samples are prepared according to the extraction conditions specified for the product.
- Selection of Test System: Typically, rabbits or, alternatively, validated in-vitro models are used.
- Application and Observation: The extract is applied to the specified site and subsequently observed at defined intervals.
- Evaluation and Assessment: The obtained results are evaluated against the criteria specified in the standard.
Reasons and Significance of Irritation Testing
- Demonstration of Product Safety
- Fulfillment of Requirements in Regulatory Approval Procedures
- One of the mandatory biocompatibility tests for CE marking applications
- Prior identification of risks such as irritation, redness, and inflammation in patients
- Acquisition of safety data during the product development and design phase
Who is required to comply?
- Manufacturers of single-use medical devices
- Manufacturers of implantable devices
- Manufacturers of products that come into contact with skin or mucous membranes, such as catheters, stents, wound dressings, and contact lenses
- Companies exporting medical devices
- All stakeholders involved in the CE certification and approval process
An essential step for patient safety
Irritation tests conducted in accordance with EN ISO 10993-23 provide definitive evidence of product safety, efficacy, and biocompatibility. Through precise laboratory analyses, risks to human health are minimized, and product quality and reliability are thoroughly documented.