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医疗器械检验

共 2,903 条标准

标准列表（第 96 / 97 页）

ISO10993-5:1999 医疗器械的生物学评价.第5部分:体外细胞毒性试验Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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ISO10993-4:2017+Amd.1:2025 医疗器械生物学评价第4部分:与血液相互作用试验选择Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood

ISO10993-4:2017/Amd.1:2025 医疗器械生物学评价第4部分:与血液相互作用试验选择Biologicalevaluationofmedicaldevices-Part4Selectionoftestsforinteractionswithblood

ISO10993-4:2017 医疗器械生物学评价第4部分:与血液相互作用试验选择 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

ISO10993-3:2014 医疗器械生物学评价第3部分:遗传毒性､致癌性和生殖毒性试验 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO10993-23:2021+Amd1:2025 医疗器械生物学评价第 23 部分:刺激试验Biological Evaluation of Medical Devices - Part 23: Tests for Irritation

ISO10993-23:2021 医疗器械生物学评价第23部分:刺激试验 Biological evaluation of medical devices - Part 23: Tests for irritation

ISO10993-18:2020+Amd1:2022 医疗器械生物学评价:第18部分:风险管理过程中医疗器械材料的化学表征Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process

ISO10993-18:2020 医疗器械生物学评价第18部分:风险管理过程中医疗器械材料的化学特性Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

ISO10993-17:2023+Amd1:2025 医疗器械生物学评价第17部分:医疗器械成分的毒理学风险评估Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents

ISO10993-17:2023 医疗器械生物学评价第17部分:医疗器械成分的毒理学风险评估 Biological evaluation of medical devices -Part 17:Toxicological risk assessment of medical device constituents

ISO10993-17:2002 医疗器械的生物学评价第17部分:可浸出物质允许限值的确定 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

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ISO10993-16:2017 医疗器械生物学评价第16部分:降解产物和可溶出物的毒代动力学研究设计 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

ISO10993-15:2019 医疗器械生物学评价第15部分:金属与合金降解产物的定性与定量 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

ISO10993-14:2001 医疗器械生物学评价第14部分:陶瓷制品降解产物的定性与定量 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

ISO10993-13:2010 医疗器械生物学评价第13部分:聚合物医疗器械降解产物的定性与定量 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

ISO10993-12:2021 医疗器械生物学评价第12 部分:样品制备与参照材料Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

ISO10993-11:2017 医疗器械生物学评价第11部分:全身毒性试验 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

ISO10993-10:2021 医疗器械生物学评价第10部分:皮肤致敏试验 Biological evaluation of medical devices - Part 10: Tests for skin sensitization

ISO10993-10:2010 医疗器械的生物学评价第10部��:刺激性和皮肤致敏性试验 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

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ISO10944:2009 眼科仪器-同视机 Ophthalmic instruments - Synoptophores

ISO10944:1998 眼科仪器.同视机Ophthalmic instruments - Synoptophores

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ISO10943:2023 眼科仪器.间接检眼镜Ophthalmic instruments - Indirect ophthalmoscopes

ISO10943:2011 眼科仪器-间接检眼镜 Ophthalmic instruments - Indirect ophthalmoscopes

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ISO10942:2022 眼科仪器.直接检眼镜Ophthalmic instruments - Direct ophthalmoscopes

ISO10942:2006 眼科仪器-直接检眼镜 Ophthalmic instruments - Direct ophthalmoscopes

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ISO10940:2009 眼科仪器-眼底照相机 Ophthalmic instruments - Fundus cameras

ISO10939:2017 眼科仪器 - 狭缝灯显微镜Ophthalmic instruments - Slit-lamp microscopes

ISO10939:2007 眼科仪器-裂隙灯显微镜 Ophthalmic instruments - Slit-lamp microscopes

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ISO10938:1998 眼科仪器-图表投影仪 Ophthalmic instruments - Chart projectors

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