贴剂用医用胶带安全要求的探讨.ppt

Ⅲ.生物相容性 * 如果不进行有效的安全测试？ 生物相容性测试 医用产品必须通过国际标准ISO-10993，医疗设备的生物 评估，第一部分：评估测试推荐的广泛的安全和效用评估 过敏反应 化学伤害 * Part 1: Evaluation and testing Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityPart 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicityPart 6: Tests for local effects after implantationPart 7: Ethylene oxide sterilization residualsPart 8: Selection and qualification of reference materials for biological testsPart 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materialsPart 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloysPart 16: Toxicokinetic study design for degradation products and leachablesPart 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materials Part 19: Physico-chemical, morphological and topographical characterization of materials Part 20: Principles and methods for immunotoxicology testing of medical devices * * 细胞毒性 - 浸提液实验 - 直接接触实验 - 间接接触实验（琼脂扩散） 皮肤刺激实验 - 体外刺激 - 动物皮肤刺激 - 人体皮肤刺激 - 21天人体累计刺激实验（Draize） 致敏实验 - 最大剂量试验（GPMT） - 封闭式贴敷试验（Buehler试验） - 人体重复接触致敏（Draize RIPT） * 目的：评价材料或其提取成分对细胞的影响（生长、代谢、损伤、死亡） 测试依据：ISO10993-5：1992医疗器械生物学评价 第5部分：细胞 毒性试验：体外法 测试方法：琼脂覆盖法 细胞毒性数据 定性评价 0.0 无细胞毒性 0.1～0.9 最小 1.0～1.8 轻微 1.9～2.8 中度 2.9～4.0 重度 4.0 极度 *应由合格的专业人员根据试验数据对结果进行总体评价 * 试验目的：评价材料引起皮肤刺激反应的潜在性 测试依据：I