ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity: 規(guī)定了醫(yī)療設(shè)備材料體外細(xì)胞毒性測(cè)試方法,適用于皮膚細(xì)胞檢測(cè),評(píng)估材料生物兼容性。
ASTM F813-07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices: 提供了材料與細(xì)胞直接接觸的評(píng)估流程,用于檢測(cè)細(xì)胞反應(yīng)和 viability,確保材料安全性。
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity: 中國(guó)國(guó)家標(biāo)準(zhǔn)基于ISO 10993-5,規(guī)范醫(yī)療器械體外細(xì)胞毒性測(cè)試,強(qiáng)調(diào)細(xì)胞培養(yǎng)和終點(diǎn)分析。
ISO 19007:2018 Cosmetics - In vitro skin corrosion - Human skin model test: 國(guó)際標(biāo)準(zhǔn)用于化妝品皮膚腐蝕性測(cè)試,涉及角質(zhì)形成細(xì)胞模型,評(píng)估產(chǎn)品安全性。
OECD TG 439 In Vitro Skin Irritation: Reconstructed Human Epidermis Test: 經(jīng)濟(jì)合作與發(fā)展組織指南,規(guī)范體外皮膚刺激性測(cè)試 using keratinocyte models, for chemical safety assessment.