EN ISO 10993-10 describes the procedure for the assessment of possible contact hazards from chemicals released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization.
The tests included in EN ISO 10993-10 are important tools for the development of safe products, provided that these are executed and interpreted by trained personnel.
EN ISO 10993-10 includes:
— pretest considerations for irritation, including in silico and in vitro methods for dermal exposure,
— details of in vivo (irritation and sensitization) test procedures,
— key factors for the interpretation of the results.
Instructions are given for the preparation of materials specifically in relation to the above tests. In addition, several special irritation tests are described for application of medical devices in areas other than skin.
EN ISO 10993-10 is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcomes of the evaluation for each medical device.
It is important they take into consideration all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.
The international standard has been approved in Europe as EN ISO 10993-10:2013 without any changes and it supersedes EN ISO 10993-10:2010.
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