BS EN ISO 10993-10:2013 pdf.Biological Evaluation Of Medical Devices – Part10:Tests For Irritation And Skin Sensitization.
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
This part of ISO 10993 includes:
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
c) key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1 and the following apply.
3.1
allergen
sensitizer
substance or material that is capable of inducing a specific hypersensitivity reaction upon repeated contact with that substance or material
3.2
blank
extraction vehicle not containing the test material, retained in a vessel identical to that which holds the test material and subjected to identical conditions to which the test material is subjected during its extraction
NOTE The purpose of the blank control is to evaluate possible confounding effects due to the extraction vessel, vehicle and extraction process.
3.3
challenge
elicitation
process following the induction phase, in which the immunological effects of subsequent exposures in an individual to the inducing material are examined
3.4
dose
dosage
amount of test sample administered (e.g. mass, volume) expressed per unit of body weight or surface area
NOTE The terms are often used interchangeably (more commonly dosage).
3.5
erythema
reddening of the skin or mucous membrane
3.6
eschar
scab or discoloured slough of skin
3.7
extract
liquid or suspension that results from exposing a test or control material to a solvent under controlled conditions
4 General principles — Step-wise approach
The available methods for testing irritation and sensitization were developed specifically to detect skin and mucous membrane irritation and skin sensitization potential. Other types of adverse effect are generally not predicted by these tests. 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 shall be used as described in 6.4.
This part of ISO 10993 requires a step-wise approach, which shall include one or more of the following:
a) characterization of test material, involving chemical characterization and analysis of the test sample according to the general principles described in ISO 10993-9, ISO 10993-13, ISO 10993-14, ISO 10993-15 and ISO 10993-1 8;
b) literature review, including an evaluation of chemical and physical properties, and information on the irritation and sensitization potential of any product constituent as well as structurally-related chemicals and materials;
c) in accordance with ISO 10993-2, in vitro tests in preference to in vivo tests shall be considered, and replacement of the latter as new in vitro tests are scientifically validated and become reasonably and practicably available. For the evaluation of skin irritation and corrosion, in vitro alternatives are available for chemicals; there are currently no internationally validated and accepted in vitro tests to detect sensitizers;