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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
MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
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
Biological evaluation of medical devices. Sample preparation and reference materials
Biological evaluation of medical devices. Sample preparation and reference materials
Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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
Biological evaluation of medical devices. Guidance on nanomaterials
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
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
Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
Medical device biological evaluation nanomaterials hemolysis test
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
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
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
MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
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
Biological evaluation of medical devices. Sample preparation and reference materials
Biological evaluation of medical devices. Sample preparation and reference materials
Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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
Biological evaluation of medical devices. Guidance on nanomaterials
Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
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
Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
Medical device biological evaluation nanomaterials hemolysis test
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
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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