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国家将修改医疗器械标准

Source:  Time:2017/2/24 13:24:49  Hits:815

      国务院近日印发《“十三五”国家药品安全规划》,“十三五”期间,中国将进一步提高药品质量,不断提升相关标准,逐步完善审评审批体系,推进健康中国建设。
规划强调,鼓励企业开展一致性评价工作,完善一致性评价工作机制,充实专业技术力量,严格标准、规范程序,鼓励研发创新;要加强生产、流通、使用等全流程监管,严肃查处药品生产偷工减料、掺杂使假等违法违规行为;健全法规标准体系,构建药品质量安全。
规划指出,“十三五”期间将制修订国家药品标准3050个,医疗器械标准500项,化妆品禁、限用物质检验检测方法30至50项,完善相关技术标准和技术指导原则。
 
→YY0459-外科植入材料 丙烯酸类树脂骨水泥Implants for Surgery-Acrylic Resin Cements;
→ISO 5833:2002,IDT外科植入材料-丙烯酸类树脂骨水泥(英文版);
→YY/T0342-外科植入物接骨板弯曲强度和刚度的测定;Implants for surgery-Determination of bending strength and stiffness of bone plate (ISO 9585:1990,IDT);
→YY0341-骨接合用无源外科金属植入物通用技术条件General technological requirements for non-active metallic surgical implementations for osteosynthesis;
→YY0017-骨接合植入物金属接骨板Implants for osteosynthesis-Metallic Bone Plates;
→ISO 13356-Implants for surgery-Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP);
→NF S94-063-Implants for surgery- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
→ASTM F382-2014 Standard Specification and Test Method for Metallic Bone Plates;
→DIN ISO 5832外科植入物.金属材料:锻造不锈钢;非合金钛;锻造钛6铝4钒合金;钴铬钼铸合金;
锻造钴-铬-钨-镍合金;煅制钴镍铬钼合金;可锻和冷加工的钴铬镍钼铁合金;锻制钴镍铬钼钨铁合金;锻造高氮不锈钢;锻制6钛/7铝/铌合金;锻造钴-铬-钼合金;
→ASTM E8M-04.Standard Test Methods for Tension Testing of Metallic Materials [Metric] 金属材料的抗拉试验方法;
→YY0018-骨接合植入物 金属接骨螺钉Implants for osteoporosis- Metal bone screws;
→YY/T0662外科植入物 不对称螺纹和球形下表面金属的金属接骨螺钉 机械性能要求和试验方法;
→YY/T0727.1-外科植入物 金属髓内钉系统 第1部分:髓内钉;
→YY/T0509(ASTM F2502)生物可吸收内固定板和螺钉的标准要求和测试方法Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants;
→ISO 6475 Implants for surgery-Metal bone screws with asymmetrical thread and spherical under-surface-Mechanical requirements and test methods》;
→ISO5835外科植入物.不对称螺纹的六角头球面颈金属骨螺钉.尺寸;
→ISO9268Implants for surgery; metal bone screws with conical under-surface of head; dimensions;
→ASTM F543《Standard Specification and Test Methods for Metallic Medical Bone Screws》;
→ASTM F116 医疗用螺丝刀Standard Specification for Medical Screwdriver Bits;
→0.5N.m/1N.m/2N.m/5N.m/10N.m/20N.m/50N.m/100N.m/200N.m/500N.m接骨螺钉扭矩试验机;
→0.5N.m/1N.m/2N.m/5N.m/10N.m/20N.m/50N.m/100N.m/200N.m/Bone screw torsion testing machine;
→50kN/100kN/200kN/300kN骨科植入物试验机;
→50kN/100kN/200kN/300kN.Orthopaedics Testing Machine/Metallic Bone Plates Testing Machine;
→10N/20N/50N/100N/200N/220N/300N微型拉力试验机;
→0.001N.m~10N.m生物医学扭力试验机Torsion Testing Machine;
→5N.m/10N.m/20N.m/50N.m/100N.m医用螺钉扭转试验机;
→0.5N.m/1N.m/2N.m/5N.m/10N.m/20N.m/50N.m/100N.m微机控制医用螺钉扭矩试验机(桌上型);
→50kN/100kN/200kN/300kN.骨科力学试验机(CE)Orthopaedic Testing Machine;
→50kN/100kN/200kN/300kN.Metallic Bone Plates Testing Machine;
→50kN/100kN/200kN/300kN.骨科接骨板试验机(CE)
→50kN/100kN/200kN/300kN.Orthopaedics Testing Machine;
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