首页 馆藏资源 舆情信息 标准服务 科研活动 关于我们
历史 ASTM F1609-08(2014)
到馆提醒
收藏跟踪
购买正版
Standard Specification for Calcium Phosphate Coatings for Implantable Materials 用于植入材料的磷酸钙涂层的标准规范
发布日期: 2014-03-01
1.1本规范涵盖了外科植入物应用中磷酸钙涂层的材料要求。 1.2在颗粒和整体形式中,磷酸钙材料系统在生物反应方面具有良好的特性 (1,2) 2. 和实验室特征 (2-4) . 几份出版物 (5-10) 记录了 体外 和 体内 选定磷酸钙涂层系统的性能。 1.3本规范包括羟基磷灰石涂层、磷酸三钙涂层或其组合,无论是否有意添加其他陶瓷或金属, 3. 并通过包括但不限于以下方法应用:( 1. )机械捕捉( 2. )等离子喷涂沉积( 3. )浸渍/烧结( 4. )电泳沉积( 5. )陶瓷化,以及( 6. )溅射。 1.4基底可包括光滑、多孔、纹理和其他可植入地形形式。 1.5本规范不包括可能含有钙和磷离子物种的有机涂层。 1.6 警告- 环保局和许多国家机构已将汞指定为一种有害物质,可导致中枢神经系统、肾脏和肝脏损害。汞或其蒸汽可能对健康有害,并对材料具有腐蚀性。处理汞和含汞产品时应小心。有关详细信息,请参阅适用的产品材料安全数据表(MSDS)和EPA网站(http://www.epa.gov/mercury/faq.htm)了解更多信息。用户应意识到,州法律可能禁止在您所在州销售汞或含汞产品,或同时销售两者。
1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. 1.2 In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2) 2 and laboratory characterization (2-4) . Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems. 1.3 This specification includes hydroxylapatite coatings, tricalcium phosphate coatings, or combinations thereof, with or without intentional minor additions of other ceramic or metallic, 3 and applied by methods including, but not limited to, the following: ( 1 ) mechanical capture, ( 2 ) plasma spray deposition, ( 3 ) dipping/sintering, ( 4 ) electrophoretic deposition, ( 5 ) porcelainizing, and ( 6 ) sputtering. 1.4 Substrates may include smooth, porous, textured, and other implantable topographical forms. 1.5 This specification excludes organic coatings that may contain calcium and phosphate ionic species. 1.6 Warning— 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 Material Safety Data Sheet (MSDS) for details and EPA’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.
分类信息
关联关系
研制信息
归口单位: F04.13
相似标准/计划/法规
现行
ASTM F1609-23
Standard Specification for Calcium Phosphate Coatings for Implantable Materials
植入式材料用磷酸钙涂层的标准规范
2023-07-01
现行
GOST 31615-2012
Имплантаты для хирургии. Стандартный метод испытаний для проверки на сдвиг фосфатно-кальциевых и металлических покрытий
手术植入物 磷酸钙涂层和金属涂层剪切试验的标准试验方法
2012-05-24
现行
YY/T 0988.13-2016
外科植入物涂层 第13部分:磷酸钙、金属和磷酸钙/金属复合涂层剪切和弯曲疲劳试验方法
Coatings of surgical implants—Part 13:Test method for shear and bending fatigue testing of calcium phosphate and metallic and calcium phosphate/metallic coating
2016-03-23
现行
YY/T 0988.12-2016
外科植入物涂层 第12部分:磷酸钙 涂层和金属涂层剪切试验方法
Coatings of surgical implants—Part 12:Shear testing method of calcium phosphate coating and metallic coatings
2016-03-23
现行
YY/T 0988.11-2016
外科植入物涂层 第11部分:磷酸钙涂层和金属涂层拉伸试验方法
Coatings of surgical implants—Part 11:Tension testing method of calcium phosphate coating and metallic coatings
2016-03-23
现行
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
Implants for surgery—Standard test method for dissolution testing of calcium phosphate granules,fabricated forms and coatings
2018-12-20
现行
ASTM F1044-05(2017)e1
Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
磷酸钙涂层和金属涂层剪切试验的标准试验方法
2017-12-01
现行
ASTM F1160-14(2017)e1
Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
磷酸钙和金属医用复合磷酸钙/金属涂层的剪切和弯曲疲劳试验标准试验方法
2017-12-01
现行
ASTM F1147-24
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
磷酸钙和金属涂层张力试验的标准试验方法
2024-05-01
现行
YY/T 0683-2008
外科植入物用β-磷酸三钙
Standard specification for beta-tricalcium phosphate for surgical implantation
2008-10-17
现行
ASTM F1926/F1926M-14(2021)
Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
磷酸钙颗粒 制造形式和涂层的溶出度测试的标准测试方法
2021-06-01
现行
ASTM F1137/F1137M-19
Standard Specification for Phosphate/Oil Corrosion Protective Coatings for Fasteners
紧固件用磷酸盐/油腐蚀保护涂层的标准规范
2019-06-15
现行
ASTM F2224-09(2020)
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
高纯度硫酸钙半水合物或手术植入物二水合物的标准规范
2020-08-01
现行
ASTM F1088-23
Standard Specification for Medical-Grade Beta-Tricalcium Phosphate Raw Material for Implantable Medical Devices
植入式医疗器械用医用级β-磷酸三钙原料的标准规范
2023-04-15
现行
ASTM F1580-18
Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants
外科植入物涂层用钛和钛-6铝-4钒合金粉末的标准规范
2018-11-15