外科植入无机骨检测

外科植入无机骨检测项目报价？  解决方案？  检测周期？  样品要求？

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YY/T 0924.1-2014外科植入物 部分和全膝关节假体股骨和胫骨部件 第1部分:分类、定义和尺寸标注

YY/T 0924的本部分对膝的一个或多个间室的支撑面置换的膝关节假体的股骨、胫骨和髌骨部件进行了分类,并给出了部件定义和尺寸标注。

YY/T 0964-2014外科植入物 生物玻璃和玻璃陶瓷材料

本标准规定了外科植入物用生物玻璃和玻璃陶瓷的材料要求和测试技术,本标准所述材料可用于多孔状和粉末状外科植入物,也可用于外科器械的涂层,但不包括药物输送系统。生物玻璃和玻璃陶瓷与骨和软组织的生物学反应已经在临床应用和实验室研究中得到验证。本标准不包含合成羟基磷灰石、羟基磷灰石涂层,氧化铝陶瓷,α-磷酸三钙和β-磷酸三钙以及白磷钙石。

YY/T 1447-2016外科植入物 植入材料磷灰石形成能力的体外评估

本标准规定了在模拟体液（SBF）中材料表面形成的磷灰石的检测方法。

YY/T 1575-2017组织工程医疗器械产品 修复和替代骨组织植入物骨形成活性的体内评价指南

本标准规定了修复和替代骨组织缺损的植入物骨形成活性的体内评价通则。本标准中的植入物可由天然或合成生物材料(可生物降解)，或其复合物构成。本标准描述了大鼠、兔、犬、猪、羊等不同种属的动物模型和相应的试验程序，以及形态学、组织生物化学和生物力学分析等结果测定和评价方法。本标准适用于修复和替代骨组织缺损的植入物。

YY/T 1640-2018外科植入物 磷酸钙颗粒、制品和涂层溶解性的试验方法

本标准规定了评价磷酸钙材料溶解速率的试验方法。本标准适用于外科植入物用磷酸钙材料，包括符合GB 23101.1、GB 23101.2的羟基磷灰石，符合YY/T 0683规定的β-磷酸三钙和无添加或添加了其他次要成分(＜10%)的双相复合物等。

ASTM F1581-2008外科植入物无机骨组成的标准规范

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3). Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7). 1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4 This standard does not pruport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).

ASTM F1581-2008(2016)外科植入物用无机骨组成的标准规格

1.1x00a0;This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2x00a0;The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7). 1.3x00a0;This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5x00a0;Warningx2014;Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (DS) for details and EPAx2019;s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 1.6x00a0;This standard does not purport to address all of the safety concerns, such as health concerns due to the presence of transmissible disease, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. (See Appendix X2).

ASTM F1581-2008(2020)外科植入物用无机骨成分的标准规范

1.1 This specification covers material requirements for anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. For a material to be called anorganic or deorganified bone, it must conform to this specification (see Appendix X1). 1.2 The biological response to apatite in soft tissue and bone has been characterized by a history of clinical use and by laboratory studies (1, 2, 3).2 Xenogeneic bone, with organic components present, has been shown to be antigenic in the human host (4) whereas the same material that has been completely deorganified has been shown to elicit no inflammatory or foreign body reactions in human clinical use (5, 6, 7). 1.3 This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 Warning—Mercury has been designated by many regulatory agencies as a hazardous substance that can cause serious medical issues. Mercury, or its vapor, has been demonstrated to be hazardous to health and corrosive to materials. Use caution when handling mercury and mercury-containing products. See the applicable product Safety Data Sheet (SDS) for additional information. The potential exists that selling mercury or mercury-containing products, or both, is prohibited by local or national law. Users must determine legality of sales in their location. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriat

DIN EN ISO 13504-2012牙科. 牙科植体位置和治疗使用仪器和相关配件的一般要求 (ISO 13504-2012); 德文版本EN ISO 13504-2012

This Standard specifies general requirements for instruments and related accessories to be used specifically in dental implantology in the craniofacial area. These requirements apply to instruments when they are manufactured. This includes instruments for single-use and reusable instruments.This International Standard applies to instruments used on the patient which are manually driven instruments and to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.