貼劑用醫(yī)用膠帶安全要求的探討(文件)
【正文】 低密度聚乙烯 169。 可追溯性 —— 由 LOT批號(hào)追蹤使用的原材料和生產(chǎn)工藝條件 167。松脂從化學(xué)成分來說，它是樹脂酸溶解在萜烯中的 種溶液 ? 松香在工業(yè)和民用產(chǎn)品中應(yīng)用廣泛 ? 過敏癥狀主要是急性接觸性過敏性皮炎和哮喘 Contact dermatitis from adhesive plaster Reaction to ankle strapping Facial rash from rosin in makeup 169。 3M 2023. All Rights Reserved. 3M Medical Specialties 3M臨床研究 另外， 3M進(jìn)行了大量的 臨床研究 ，以確保產(chǎn)品用于人體的 安全性和舒適性 Short term: 0h,4h,24h Long term: 0h,24h,48h,72h 169。 169。 3M 2023. All Rights Reserved. 3M Medical Specialties 豚鼠皮膚致敏（ Buehler法） 目的： 評(píng)價(jià)材料在試驗(yàn)條件下導(dǎo)致豚鼠皮膚致敏反應(yīng)的潛在性。 3M 2023. All Rights Reserved. 3M Medical Specialties 原發(fā)性皮膚刺激實(shí)驗(yàn) 試驗(yàn)?zāi)康模?評(píng)價(jià)材料引起皮膚刺激反應(yīng)的潛在性 測試依據(jù)： ISO 1099310： 1995醫(yī)療器械生物學(xué)評(píng)價(jià) 第 10部分：刺 激與致敏試驗(yàn) 試驗(yàn)對(duì)象： 白化兔 試驗(yàn)方法： 動(dòng)物背部脊柱兩側(cè)去毛， 25mm 25mm的試樣貼敷并用紗 布包扎固定至少 4h，移除試樣后 1h、 24h、 48h、 72h觀察皮膚反應(yīng)。 3M 2023. All Rights Reserved. 3M Medical Specialties ISO10993: Biological evaluation of medical devices Part 1: Evaluation and testing Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 8: Selection and qualification of reference materials for biological tests Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayedtype hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 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 alloys Part 16: Toxicokiic study design for degradation products and leachab
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