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医疗器械生物学评价 第16部分：降解产物和浸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

医疗器械 生物相容性 第8部分：选择和鉴定用于生物学试验的参考材料

Biological evaluation of medical devices—Part 8: Selection and qualification of reference materials for biological tests

眼科植入物 – 人工晶状体 – 第5部分：生物相容性

Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility

医疗器械的生物学评价.第1部分:在风险管理系统内的评价与试验

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009

医疗器械的生物学评价 第23部分：刺激试验（ISO 10993-23:2021）；德文版 EN ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021

医疗器械的生物学评价 第3部分：遗传毒性、致癌性和生殖毒性的试验（草案）

Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (draft)

医疗美利体育官网首页网址的生物学评价.第6部分:植入后局部效果试验(ISO 10993-6-2016);德文版本EN ISO 10993-6-2016

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016

医疗器械的生物学评价 第9部分：潜在降解产物的识别和量化框架（ISO/DIS 10993-9:2018）

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO/DIS 10993-9:2018); German and English version prEN ISO 10993-9:2018

光辐射物理学和照明工程.第100部分:人类视觉光线的非视觉影响.数量、符号和行动范围

Optical radiation physics and illuminating engineering - Part 100: Non-visual effects of ocular light on human beings - Quantities, symbols and action spectra

牙科 - 用于牙科医疗器械的生物相容性的评估

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

医疗器械的生物学评价 第12部分：样品制备和参考物质（ISO 10993-12:2012）

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

医疗器械生物学评价 第12部分：样品制备和参考材料

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

医用美利体育官网首页网址的生物评估 第1部分：风险管理过程中的评价和测试（ISO 10993-1:2018 包括2018-11修正版）

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)

牙科 牙科用医疗器械生物相容性评估

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

可吸收医疗器械生物学评价 第1部分：可吸收植入物指南

Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants