BS EN ISO 10993-10:2013 pdf free download.Biological evaluation of medical devices – Part 10: Tests for irritation and skin
sensitization.The size of this pdf file is 25.3M.
BS EN ISO 10993-10:2013 assesses possible contact hazards from chemicals released from medical devices,which may produce skin and mucosal irritation, eye irritation or skin sensitization.
Some materials that are included in medical devices have been tested, and their skin or mucosal irritation sensitization potential has been documented. Other materials and their chemical components have not been tested and may induce adverse effects when in contact with human tissue. The manufacturer is thus obliged to evaluate each device for potential adverse effects prior to marketing.
Traditionally, small animal tests are performed prior to testing on humans to help predict human response.More recently, in vitro tests as well as human tests have been added as adjuncts or alternatives. Despite progress and considerable effort in this direction, a review of findings suggests that currently no satisfactory in vitro test has been devised to eliminate the requirement for in vivo testing. Where appropriate, the preliminary use of in vitro methods is encouraged for screening purposes prior to animal testing. In order to reduce the number of animals used, this part of ISO 10993 presents a step-wise approach, with review and analysis of test results at each stage. An animal test is usually required prior to human testing.
It is intended that these studies be conducted using Good Laboratory Practice and comply with regulations related to animal welfare. Statistical analysis of data is recommended and should be used whenever appropriate.
This part of ISO 10993 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, nking 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 tests included in this part of ISO 10993 are important tools for the development of safe products, provided that these are executed and interpreted by trained personnel.
BS EN ISO 10993-10:2013 is based on numerous standards and guidelines, including OECD Guidelines U. S Pharmacopoeia and the European Pharmacopoeia. It is intended to be the basic document for the selection and conduct of tests enabling evaluation of irritation and dermal sensitization responses relevant to safety of medical materials and devices.
BS EN ISO 10993-10:2013 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.