BS EN ISO 10993-9-2009 医疗器械的生物学评估.潜在降解产物的鉴别和定量框架

标准号：BS EN ISO 10993-9-2009
中文标准名称：医疗器械的生物学评估.潜在降解产物的鉴别和定量框架
英文标准名称：Biological evaluation of medical devices - Framework for identification and quantification of potential degradation products
标准类型：C30
发布日期：2010/6/30 12:00:00
实施日期：2010/6/30 12:00:00
中国标准分类号：C30
国际标准分类号：11.100.20
适用范围：This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observedbiodegradation of medical devices and for the design and performance of biodegradation studies. Informationobtained from these studies can be used in the biological evaluation described in the ISO 10993 series. Thispart of ISO 10993 considers both non-resorbable and resorbable materials.This part of ISO 10993 is not applicable to:a) evaluation of degradation which occurs by purely mechanical processes; methodologies for theproduction of this type of degradation product are described in specific product standards, whereavailable;b) leachable components which are not degradation products;c) medical devices or components that do not contact the patient's body directly or indirectly.NOTE 2 This part of ISO 10993 can be applied to the degradation of materials used in any kind of product that fallswithin the definition of “medical device” in ISO 10993-1, even if such products are subject to different regulations fromthose applying to medical devices, e.g. the scaffold in a tissue engineered medical product, or a carrier matrix to deliverdrugs or biologics.