ISO 10993-23 is one of a series of documents for biological evaluation of medical devices that specifies the procedure for the assessment of medical devices and their constituent materials regarding their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials, or their extracts according to ISO 109931 and ISO 1099-32.
ISO 10993-23 includes pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure, details of in vitro and in vivo irritation test procedures, and key factors for the interpretation of the results.
ISO 10993-23 is applicable to-
Provided tests in ISO 10993-23 are important tools for the development of safe products if they are executed and interpreted by trained personnel. It is based on numerous standards and guidelines, including OECD Test Guidelines (TG), U.S. Pharmacopoeia, and the European Pharmacopoeia. ISO 1099-23 is intended for the selection and conduct of tests enabling evaluation of irritation responses relevant to the safety of medical materials and devices.
In vitro tests as well as human tests have been added as adjuncts or alternatives. For skin irritation testing of neat chemicals in vitro tests were developed using reconstructed human epidermis models. The method was adapted for the detection of irritant chemicals in medical device extracts. The results of a large round-robin study that tested two types of reconstructed human epidermis models showed that these models can also be used to detect the presence of irritant chemicals extracted from polymeric materials [polyvinylchloride (PVC) and silicone] commonly used in the manufacture of medical devices.
ENISO 10993-23
ISO 10993-23