ASTM F1251-89(2003 医疗和外科器械用聚合生物材料的相关术语
1.1 This terminology covers polymeric biomaterials in medical and surgical devices. Terms are defined as they are used relative to medical
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
NF S90-701:1988 外科医疗器械.材料和医疗设备的生物兼容性.萃取法
MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
BS EN ISO 10993-12:2007 医疗器械的生物学评估.样品制备和参考材料
ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection
Biological evaluation of medical devices - Sample preparation and reference materials
BS EN ISO 10993-12:2012 医疗器械的生物学评价. 样品制备和参考材料
Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 10993-12:2021 医疗器械的生物学评价 样品制备和参考材料
Biological evaluation of medical devices. Sample preparation and reference materials
GOST ISO 10993-12-2011 医疗器械.医疗器械的生物学评价.第12部分.样品制备和控制材料
Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST ISO 10993-18-2011 医疗器械.医疗器械的生物学评价.第18部分.材料的化学特征
Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
T/CAMDI 033-2020 医疗器械包装材料的生物学评价指南
本标准提供了用于确定医疗器械菌屏障系统中材料（或包装材料）的生物相容性试验的指南。 本标准不涉及包装材料的所有安全问题
Guide for biological evaluation of packaging materials for medical devices
PD ISO/TR 10993-22:2017 医疗器械的生物学评价 纳米材料指南
Biological evaluation of medical devices. Guidance on nanomaterials
ISO 10993-18:2020/Amd.1:2022 医疗器械的生物学评估 风险管理过程中医疗器械材料的化学特性
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-18:2020+A1:2023 医疗器械的生物学评估 风险管理过程中医疗器械材料的化学特性
1 Scope This document specifies a framework for the identification , and if necessary, quantification of constituents of a medical
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
GOST ISO/TS 10993-19-2011 医疗器械.医疗器械的生物学评价.第19部分.材料的生理生化试验,形态学和拓扑学特征
Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
YY/T 1532-2017 医疗器械生物学评价纳米材料溶血试验
Medical device biological evaluation nanomaterials hemolysis test
GB/Z 16886.22-2022 医疗器械生物学评价 第22部分：纳米材料指南
本文件提供了由纳米材料组成或包含纳米材料的医疗器械的生物学评价的考虑因素,以及在医疗器械(或组件)生产过程中未使用纳米材料,但其降解、磨损或在机械处理过程中(如医疗器械原位研磨、抛光等)产生的纳米物体的评价等方面的指导。 本文件适用于以下内容: ———纳米材料的表征; ———用于纳米材料测试的样品
Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.18-2022 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
本文件规定了医疗器械成分的定性和定量(如必要)框架,通过渐进式的化学表征进行材料成分的生物学危险(源)识别以及其生物学风险评估和控制。 本文件适用于以下一项或多项: ———其制造材料的定性(医疗器械构造); ———通过材料化学成分的定性和定量进行的制造材料的表征(材料组成); ———针对医疗器械在
Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
ASTM F1251-89(2003 医疗和外科器械用聚合生物材料的相关术语
1.1 This terminology covers polymeric biomaterials in medical and surgical devices. Terms are defined as they are used relative to medical
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
NF S90-701:1988 外科医疗器械.材料和医疗设备的生物兼容性.萃取法
MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
BS EN ISO 10993-12:2007 医疗器械的生物学评估.样品制备和参考材料
ISO 10993-12:2007 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection
Biological evaluation of medical devices - Sample preparation and reference materials
BS EN ISO 10993-12:2012 医疗器械的生物学评价. 样品制备和参考材料
Biological evaluation of medical devices. Sample preparation and reference materials
BS EN ISO 10993-12:2021 医疗器械的生物学评价 样品制备和参考材料
Biological evaluation of medical devices. Sample preparation and reference materials
GOST ISO 10993-12-2011 医疗器械.医疗器械的生物学评价.第12部分.样品制备和控制材料
Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST ISO 10993-18-2011 医疗器械.医疗器械的生物学评价.第18部分.材料的化学特征
Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
T/CAMDI 033-2020 医疗器械包装材料的生物学评价指南
本标准提供了用于确定医疗器械菌屏障系统中材料（或包装材料）的生物相容性试验的指南。 本标准不涉及包装材料的所有安全问题
Guide for biological evaluation of packaging materials for medical devices
PD ISO/TR 10993-22:2017 医疗器械的生物学评价 纳米材料指南
Biological evaluation of medical devices. Guidance on nanomaterials
ISO 10993-18:2020/Amd.1:2022 医疗器械的生物学评估 风险管理过程中医疗器械材料的化学特性
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-18:2020+A1:2023 医疗器械的生物学评估 风险管理过程中医疗器械材料的化学特性
1 Scope This document specifies a framework for the identification , and if necessary, quantification of constituents of a medical
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
GOST ISO/TS 10993-19-2011 医疗器械.医疗器械的生物学评价.第19部分.材料的生理生化试验,形态学和拓扑学特征
Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
YY/T 1532-2017 医疗器械生物学评价纳米材料溶血试验
Medical device biological evaluation nanomaterials hemolysis test
GB/Z 16886.22-2022 医疗器械生物学评价 第22部分：纳米材料指南
本文件提供了由纳米材料组成或包含纳米材料的医疗器械的生物学评价的考虑因素,以及在医疗器械(或组件)生产过程中未使用纳米材料,但其降解、磨损或在机械处理过程中(如医疗器械原位研磨、抛光等)产生的纳米物体的评价等方面的指导。 本文件适用于以下内容: ———纳米材料的表征; ———用于纳米材料测试的样品
Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.18-2022 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
本文件规定了医疗器械成分的定性和定量(如必要)框架,通过渐进式的化学表征进行材料成分的生物学危险(源)识别以及其生物学风险评估和控制。 本文件适用于以下一项或多项: ———其制造材料的定性(医疗器械构造); ———通过材料化学成分的定性和定量进行的制造材料的表征(材料组成); ———针对医疗器械在
Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
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