ISO/TS 11796:2023 医疗器械的生物学评价 证明已确认的体外方法适用评估医疗器械的皮肤致敏性的实验室间研究要求

标准编号：ISO/TS 11796:2023

中文名称：医疗器械的生物学评价 证明已确认的体外方法适用评估医疗器械的皮肤致敏性的实验室间研究要求

英文名称：Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices

发布日期：2023-07

标准范围

本文件规定了评估和证明OECD测试指南中经验证的非动物方法的适用性的框架和方法，以评估医疗器械或医疗器械材料的皮肤致敏潜力。本文件涉及:—？参考化学皮肤致敏剂和非皮肤致敏剂数据库；—？参考资料；—？候选测试方法的可行性测试，包括用于医疗器械提取物的任何方法优化；—？候选测试方法的预验证；—？实验室间研究:—？样品制备和编码；—？加标来自阴性对照医疗器械材料的提取物；—？数据收集；—？统计分析以评估可靠性和再现性。使用本文件中描述的方法评估候选测试方法的适用性并不意味着候选测试方法可以用作标准-用于评估医疗器械皮肤致敏潜力的单独试验。对于某些候选测试方法，需要综合方法和/或定义方法。[1]ISO 10993-10描述了医疗器械皮肤致敏潜力的评估。

This document specifies the framework and the methodology to evaluate and demonstrate the applicability of a validated non-animal method from an OECD test guideline to assess the skin sensitizing potential of a medical device or a medical device material. This document addresses:

—    the database of reference chemical skin sensitizers and non-skin sensitizers;

—    reference materials;

—    feasibility testing of candidate test methods, including any method optimization for use with extracts of medical devices;

—    prevalidation of candidate test methods;

—    the interlaboratory study:

—    sample preparation and coding;

—    spiking of the extracts from the negative control medical device material;

—    data collection;

—    statistical analysis to assess reliability and reproducibility.

The use of the approaches described in this document to assess the applicability of a candidate test method does not imply that the candidate test method can be used as a stand-alone test for evaluating the skin sensitization potential of medical devices. For certain candidate test methods, integrated approaches and/or defined approaches are needed.^[1] The evaluation of skin sensitization potential of a medical device is described in ISO 10993-10.

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