BS PD ISO/TR 10993-22:2017描述了以下医疗器械生物学评估的注意事项: 由纳米材料组成或包含纳米材料。此外，本指南也可用于评估 由降解、磨损或机械处理过程产生的纳米物体 （例如，医疗器械的现场研磨、抛光）来自 不使用纳米材料制造。本文件包括以下方面的考虑:纳米材料的表征；纳米材料测试用样品制备；从医疗设备中释放纳米物体； 纳米物体的毒代动力学；纳米材料的生物学评价；介绍结果；医疗器械评估中纳米材料的风险评估；生物评价报告；医疗设备表面的纳米结构，在工程设计过程中有意产生， 医疗器械的制造或加工。本文件不包括以下内容:天然和生物纳米材料，只要它们尚未经过工程设计、制造或测试 处理后用于医疗器械；本体材料中的固有纳米结构；医疗器械表面的纳米结构，由- 产品在 医疗器械的工程、制造或加工。注:医疗器械表面非故意纳米结构的例子是挤压画线 以及加工/工具标记。本文件旨在提供一个总体框架，并强调以下重要方面: 在评估由、含有和/或 生成纳米物体。此外，该文件还指出了几个常见的陷阱和障碍 在测试纳米材料与块体材料或小分子材料的比较时，已经确定了这些材料 化学物种。 作为技术报告（TR），本文件代表了当前的技术知识 与纳米材料有关。未概述或提供详细的测试协议。这份文件可以 作为未来包含以纳米材料为重点的详细协议的文件的基础 测试。交叉引用:ISO 10993-11:2006ISO 10993-12:2012ISO/TR 13014:2012 ED1ISO 10993-16:2017ISO 10993-1:2009ISO 14971:2007 Ed 2（R10）ISO 10801:2010 Ed 1ISO 17973:2016ISO/TR 13097:2013 ED1ISO 24236:2005（R10）Ed 1ISO/TR 27628:2007（R10）Ed 1ISO 9276-3:2008 Ed 1ISO 21501-3:2007 Ed 1ISO 13322-1:2014 Ed 13318-3:2004 Ed 1ISO 20998- 2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年2:2013年12月12月12月12月12月12:2:2013年2:2:2013年2:2:2:2013年2:2:2:2:2:2:2:2:2:2:2:1当时当时当时当时12教育的12:1当时12 12:2:2013年2:2:2:2:2:2:1当时12 12 12教育的教育的12 12 12 12:2:2:2:2:2:2:2:1教育的12 12 12:2:2:2:2:2:1当时当时当时12 12 12 12 12 12 12 12 12 12 12 12 12-1:2006版1ISO/TR 13121:2011版1ISO/TR16197:2014 ED1ISO 18115-1:2013 ED2ISO 25178-71ISO 9276-6:2008 Ed 1ISO 13084:2011 Ed 1ISO/TR 15900ISO 11360ISO/TR15901ISO/TR 14187:2011 Ed 1ISO 17853:2011 Ed 3ISO/TS 17200:2013 ED1ISO 14488:2007 Ed 1ISO 25178-71:2012 ED1ISO/IEC 17025: 2005 Ed 1ISO/TR 16196:2016ISO 13099-2:2012 ED1ISO 14887:2000ISO 25178-72:2017ISO 20998-3:2017ISO 13318-2:2001 Ed 1ISO 24173:2009 Ed 1ISO/TS 80004-1:2015ISO/TS 80004-6:2013 ED1ISO 21501-2:2007 Ed 1ISO 19007ISO 18757:200313099-3:2014 ED1ISO 16700:2016ISO 13318-2:2007 Ed 2购买本文件时可获得的所有现行修订均包含在购买本文件中。

BS PD ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.This document includes considerations on the:characterization of nanomaterials;sample preparation for testing of nanomaterials;release of nano-objects from medical devices;toxicokinetics of nano-objects;biological evaluation of nanomaterials;presentation of results;risk assessment of nanomaterials in the context of medical device evaluation;biological evaluation report;nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.The following are excluded from this document:natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;intrinsic nanostructures in a bulk material;nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.This document is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.Cross References:ISO 10993-11:2006ISO 10993-12:2012ISO/TR 13014:2012 ED1ISO 10993-16:2017ISO 10993-1:2009ISO 14971:2007 Ed 2 (R10) ISO 10801:2010 Ed 1ISO 17973:2016ISO/TR 13097:2013 ED1ISO 24236:2005 (R10) Ed 1ISO/TR 27628:2007 (R10) Ed 1ISO 9276-3:2008 Ed 1ISO 21501-3:2007 Ed 1ISO 13322-1:2014 ED2ISO 13318-3:2004 Ed 1ISO 20998-2:2013 ED1ISO/TS 19590:2017ISO/TS 16550:2014 ED1ISO 22412:2017ISO 15471:2016ISO 22489:2016ISO 9276-4:2001 Ed 1ISO 13099-1:2012 ED1ISO 25178-2:2012ISO 25178-6:2010 Ed 1ISO 13322-2:2006 Ed 1ISO/TR 15499:2012 ED1ISO 13320:2009 Ed 1ISO 10808:2010 Ed 1ISO 22309:2011 Ed 2ISO 9277:2010 Ed 2ISO/TS 12025:2012 ED1ISO 29701:2010 Ed 1ISO 21501-4:2007 Ed 1ISO 20998-1:2006 Ed 1ISO/TR 13121:2011 Ed 1ISO/TR 16197:2014 ED1ISO 18115-1:2013 ED2ISO 25178-71ISO 9276-6:2008 Ed 1ISO 13084:2011 Ed 1ISO/TR 15900ISO 11360ISO/TR15901ISO/TR 14187:2011 Ed 1ISO 17853:2011 Ed 3ISO/TS 17200:2013 ED1ISO 14488:2007 Ed 1ISO 25178-71:2012 ED1ISO/IEC 17025:2005 Ed 1ISO/TR 16196:2016ISO 13099-2:2012 ED1ISO 14887:2000ISO 25178-72:2017ISO 20998-3:2017ISO 13318-2:2001 Ed 1ISO 24173:2009 Ed 1ISO/TS 80004-1:2015ISO/TS 80004-6:2013 ED1ISO 21501-2:2007 Ed 1ISO 19007ISO 18757:2003 (R09) Ed 1ISO/TS 80004-2:2015ISO 9276-2:2014 ED2ISO/TS 16195:2013 ED1ISO 21501-1:2009 Ed 1ISO 18144:2003 (R09) Ed 1ISO/TR 19319:2013 ED2ISO 18115-2:2013 ED2ISO 18118:2015 ED2ISO 13099-3:2014 ED1ISO 16700:2016ISO 13318-2:2007 Ed 2All current amendments available at time of purchase are included with the purchase of this document.