ISO 10993-7:2008 醫(yī)療器械生物學(xué)評(píng)價(jià)——第7部分:環(huán)氧乙烷殘留量 ISO 10993-7:2008 Biological evaluation of medical devices —Part 7:Ethylene oxide sterilization residuals
ISO 10993-6:2009 醫(yī)療器械生物學(xué)評(píng)價(jià)——第6部分:植入后局部反應(yīng)試驗(yàn) ISO 10993-6:2009 Biological evaluation of medical devices Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
ISO 10993-5:2009 醫(yī)療器械生物學(xué)評(píng)價(jià)——第5部分:體外細(xì)胞毒性試驗(yàn) ISO 10993-5:2009 Biological evaluation of medical devices —Part 5:Tests for in vitro cytotoxicity
ISO 10993-4 AMD1:2006[1] 醫(yī)療器械生物學(xué)評(píng)價(jià)——第4部分:與血液相互作用試驗(yàn)選擇 ISO 10993-4 AMD1:2006[1] Biological evaluation of medical devices —Part 4:Selection of tests for interactions with blood
ISO 10993-3:2003 醫(yī)療器械生物學(xué)評(píng)價(jià)——第3部分:遺傳毒性、致癌毒性和生殖毒性試驗(yàn) ISO 10993-3:2003 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-2-2006 醫(yī)療器械生物學(xué)評(píng)價(jià)——第2部分:動(dòng)物保護(hù)要求 ISO 10993-2-2006 Biological evaluation of medical devices—Part 2: Animal welfare requirements
ISO 10993-1:2009 醫(yī)療器械生物學(xué)評(píng)價(jià)——第1部分:風(fēng)險(xiǎn)管理程序中的評(píng)價(jià)和測(cè)試(英文版) Biological evaluation of medical devices —Part 1:Evaluation and testing within a risk management process
ISO 10993-1:2018醫(yī)療器械生物學(xué)評(píng)價(jià) 第1部分:風(fēng)險(xiǎn)管理過(guò)程中的評(píng)價(jià)與試驗(yàn) ISO 10993-1:2018 Biological evaluation of medical devices —Part 1:Evaluation and testing within a risk management process
實(shí)驗(yàn)室對(duì)比實(shí)驗(yàn)報(bào)告模板,包括穩(wěn)健統(tǒng)計(jì)法、En值法、F檢驗(yàn)+t檢驗(yàn)
ASTM f2129 - 08進(jìn)行循環(huán)電位動(dòng)力學(xué)極化測(cè)量以確定小型植入物設(shè)備的腐蝕敏感性的標(biāo)準(zhǔn)試驗(yàn)方法