The contact of medical devices with the human body involves various biological risks. In particular, for products that come into direct or indirect contact with the skin, eyes, or mucous membranes, the risk of irritation must be assessed. One of the fundamental sources that ensure 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 that determines whether a medical device or a component thereof has an irritating (irritating) effect on living tissue. Depending on the area of application and duration of contact of the product, the risk of irritation of the skin, eyes or mucous membranes is assessed.
What does the EN ISO 10993-23 standard include?
EN ISO 10993-23 is the part of the ISO 10993 series on biocompatibility that deals with the evaluation of irritation. This standard sets out the test methods and requirements to be applied to determine the irritation potential of medical devices.
Scope of contact areas:
- Skin (dermal irritation)
- Eyes (eye irritation)
- Mucous membranes (oral, vaginal, rectal areas)
How does the test work?
- Extract preparation: The samples are prepared according to the extraction conditions specified for the product.
- Test organization selection: Rabbits or alternatively validated in vitro models are usually used.
- Application and observation: The extract is applied to the designated area and subsequently observed at certain intervals.
- Evaluation and Assessment: The results obtained are evaluated on the basis of the criteria set out in the standard.
Reasons and importance of the stimulus test
- Proof of product safety
- Fulfillment of the requirements in statutory approval procedures
- in the mandatory biocompatibility tests for CE marking applications
- Previous recognition of risks such as irritation, redness and inflammation in patients
- Collection of safety data in the product development and design phase
For whom is it mandatory?
- Disposable medical device manufacturers
- Manufacturer of implantable devices
- Manufacturers of products that come into contact with the skin or mucous membranes, such as catheters, stents, wound dressings and contact lenses
- Companies that export medical products
- All parties involved in the CE certification and approval process
An indispensable step for patient safety
Irritant tests according to EN ISO 10993-23 are one of the most concrete evidence of the safety, efficacy and biocompatibility of products. Correct laboratory analyzes minimize human health risks and document product quality and reliability.