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医疗器械检验

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ISO14242-1:2014/Amd1:2018 外科植入物.全髋关节假体的磨损.第1部分:磨损试验机的载荷和位移参数及相应的试验环境条件.修改件1Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test - Amendment 1

ISO14242-1:2014 手术植入物 - 全髋关节假体的磨损 - 第1部分:磨损试验机的装载和位移参数和相应的环境条件进行试验Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

ISO14242-1:2012 外科植入物-全髋关节假体的磨损第1部分:磨损试验机的载荷和位移参数以及相应的试验环境条件 Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO14117:2019 有源植入式医疗器械电磁兼容植入式心脏起搏器､植入式心律转复除颤器和心脏再同步器械的电磁兼容测试细则Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

ISO14117:2012 主动植入式医疗器械-电磁兼容性-植入式心脏起搏器､植��式心脏复律除颤器和心脏再同步装置的EMC测试协议 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO13779-6:2015 手术植入物 - 羟基磷灰石 - 第6部分:粉末Implants for surgery - Hydroxyapatite - Part 6: Powders

ISO13779-4:2018 手术植入物 - 羟基磷灰石 - 第4部分:涂层粘附强度的测定Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength

ISO13779-3:2018 手术植入物 - 羟基磷灰石 - 第3部分:结晶度比和相纯度的化学分析和表征Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity

ISO13779-2:2018 外科植入物.羟基磷灰石.第2部分:羟基磷灰石热喷涂涂层Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite

ISO13779-2:2000 外科植入物.羟基磷灰石.第2部分:羟基磷灰石涂层Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite

废止，仅限能力项目库范围内现行有效产品标准引用本标准及监督抽检时申请...

ISO13383-1:2012 精细陶瓷(高级陶瓷､高级工业陶瓷)-显微结构特征第1部分:晶粒度和粒度分布的测定 Fine ceramics (advanced ceramics, advanced technical ceramics) - Microstructural characterization - Part 1: Determination of grain size and size distribution

ISO13356:2015 手术植入物 - 基于氧化钇稳定化四面体氧化锆(Y-Tzp)的陶瓷材料Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)

ISO13175-3:2012 外科植入物-磷酸钙第3部分:羟基磷灰石和β-磷酸三钙骨替代物 Implants for surgery - Calcium phosphates - Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes

ISO12865:2006 眼科仪器-视网膜镜 Ophthalmic instruments - Retinoscopes

ISO12243:2003/Amd.1:2012 医用天然胶乳手套用改性格雷法测量可水萃取的蛋白质MedicalglovesmadefromnaturalrubberlatexDeterminationofwater-extractableproteinusingthemodifiedLowrymethodFirstEdition

ISO12243:2003 由天然胶乳制成的医用手套-改良Lowry法测定水溶性蛋白质 Medical gloves made from natural rubber latex - Determination of water-extractable protein using the modified Lowry method

IEC60601-2-39:2024 医用电气设备第2-39部分:腹膜透析设备的基本安全和基本性能专用要求 Medical electrical equipment-Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

IEC60601-2-39:2018 医疗电气设备 - 第2-39部分:腹膜透析设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

IEC60601-2-37:2024 医用电气设备第2-37部分:超声诊断和监护设备的基本安全和基本性能专用要求 Medical electrical equipment-Part 2-37: Particular requiements for the basic safety and essential performance of ultrasonic medical diagnostic an monitoring equipment

IEC60601-2-37:2007/AMD1:2015 修改件1.医用电气设备.第2-37部分:超声医疗诊断和监测设备基本安全和基本性能的特殊要求Amendment 1 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC60601-2-37:2007 医疗电气设备 - 第2-37部分:超声医疗诊断和监测设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC60601-2-36:2014 医疗电气设备 - 第2-36部分:体外诱导碎石术设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

IEC60601-2-35:2020+AMD1:2023 医用电气设备第2-35部分:医用毯､垫或床垫式加热设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

IEC60601-2-34:2024 医用电气设备第2-34部分:有创血压监护设备的基本安全和基本性能专用要求Medical electrical equipment-Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC60601-2-34:2011 医用电气设备第2-34部分:有创血压监测设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

IEC60601-2-28:2017 医疗电气设备 - 第2-28部分:医疗诊断X射线管组件的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC60601-2-27:2011 医用电气设备第2-27部分:心电监护设备的基本安全和基本性能专用要求Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

IEC60601-2-25:2011 医用电气设备第2-25部分:心电图机的基本安全和基本性能专用要求Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

IEC60601-2-24:2012 医用电气设备第2-24部分:输液泵和输液控制器的基本安全和基本性能专用要求 Medical eletrical equipment- Part2-24:Particular requirements for the basic safety and essential performance of infusion pumps and controllers

IEC60601-2-22:2019 医用电气设备第2-22部分:外科､整形､治疗和诊断用激光设备的基本安全和基本性能专用要求 Medical electrical equipment- Part 2-22: Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment

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