ISO 10993-23-2021 pdf download

ISO 10993-23-2021 pdf download.Biological evaluation of medical devices – Part 23: Tests for irritation. 4 General principles一Step-wise approach The available methods for testing irritation were developed specifically to detect skin and mucous membrane irritation potential. Other types of adverse effects, such as sensitization, are generally not predicted by these tests. Historically irritation testing was done on rabbits. For medical devices that are used as implants or external communicating devices, intradermal testing is more relevant in approaching the application and so for detection of irritation activity, intracutaneous testing is indicated as described in 7.2. Preference for in vitro tests instead olin vivo tests in accordance with ISO 109932, shall be considered, with replacement of the latter as new in vitro tests are scientifically validated and qualified for use with medical devices and become reasonably and practicably available. The results of a large round robin study that tested two types of RhE models showed that these models can also be used to detect the presence of irritant chemicals extracted from polymeric materials Ipolyviiiylchloride (PVC) and siliconej commonly used in the manufacture of medical devicesM. This method was found equally sensitive to detect low concentrations of some strong irritant compounds when compared to the human patch testing and intracutaneous rabbit testl14l. Therefore, the in vitro irritation test shall be performed before animal testing or human patch test is considered. NOTE It can be relevant to provide detailed information of the applicability of the RhE model for the specific medical device being tested. This document describes a stepwise approach, which shall include one or more of the following: a) chemical characterization, supplemented where needed with chemical testing of samples in accordance with the general principles specified in ISO 10993-9, ISO 10993-13, ISO 10993-14, ISO 10993-15 and ISO 10993-18; b) literature review, as indicated in ISO 10993-1, including an evaluation of chemical and physical properties, and information on the irritation potential of any product constituent as well as structurally-related chemicals and materials; NOTE In sthco methods (structure activity relationship, QSAR. read across) can indicate potential irritant activity. c) in vitro alternative test using validated RhE per the methods in 62 to &12; NOTE For special irritation tests relevant for medical devices intended to be applied to a specific area (AimexJi). I.e. niucosal or eye epithelia. the RhE models are not adapted and it is recommended to explore the use of other in vitro models with...