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医疗器械检验

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ISO8637-3:2024 血液净化用体外系统第3部分:血浆过滤器Extracorporeal systems for blood purification - Part 3: Plasmafilters

ISO8637-2:2024 血液净化体外循环系统第2部分:血液透析器､血液透析滤过器､血液过滤器和血液浓缩器的体外血液回路 Extracorporeal sysytems for blood purification-Part 2: Extracorporeal blood and fluid circuits for haemodialysers,haemodiafilters,haemofilters and haemoconcentrators

ISO8637-2:2018 用于血液净化的体外系统 - 第2部分:血液透析器血液过滤器和止血器的体外血液回路Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

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ISO8637-1:2024 血液净化用体外系统第1部分:血液透析机､血液透析过滤器､血液过滤器和血液浓缩器Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

ISO8600-8:2021 内窥镜-医用内窥镜和内治疗器械-第8部分:胶囊式内窥镜专用要求Endoscopes - Medical endoscopes and endotherapy devices Part 8: Particular requirements for capsule endoscopes

ISO8600-7:2012 内窥镜-医用内窥镜和内治疗器械-第7部分:防水型医用内窥镜的基本要求Endoscopes - Medical endoscopes and endotherapy devices Part 7: Basic requirements for medical endoscopes of water-resistant type

ISO8600-5:2020 光学和光子学-医用内窥镜和内治疗器械-第5部分:用光学器件测定硬性内窥镜的光学分辨率Optics and photonics - Medical endoscopes and endotherapy devices Part 5: Determination of optical resolution of rigid endoscopes with optics

ISO8600-4:2023 内窥镜-医用内窥镜和内治疗器械-第4部分:插入部分最大宽度的测定Endoscopes - Medical endoscopes and endotherapy devices Part 4: Determination of maximum width of insertion portion

ISO8600-3:2019 内窥镜-医用内窥镜和内治疗器械-第3部分:用光学方法确定内窥镜的视场和视向Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics

ISO8600-2:2015 内窥镜-医用内窥镜和内治疗器械-第2部分:硬性气管内窥镜专用要求Endoscopes - Medical endoscopes and endotherapy devices Part 2: Particular requirements for rigid bronchoscopes

ISO8600-1:2025 内窥镜-医用内窥镜和内治疗器械-第1部分:通用要求Endoscopes - Medical endoscopes and endotherapy devices Part 1: General requirements

ISO8537:2016 无菌一次性胰岛素注射器(带针或不带针)Sterile single-use syringes,with or without needle,for insulin

ISO8536-9:2015 医疗输液设备 - 第9部分:压力输液设备一次性使用的流体管路Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment

ISO8536-8:2015 医用输液器具第8部分:一次性使用压力输液器 Infusion equipment for medical use-Part 8: Infusion sets for single use withpressure infusion apparatus

ISO8536-5:2004 医用输液设备第5部分:一次性滴定管重力输液器 Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed

ISO8536-4:2019 医疗输液设备-第4部分:单次使用输液器重力饲料Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

ISO8536-4:2010/Amd1:2013 医用输液设备第4部分:一次性重力输液器修改1Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed - Amendment 1

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ISO8536-11:2015 用于医疗用途的输液设备 - 第11部分:输液过滤器一次性用于压力输液设备Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment

ISO8536-10:2015 医用输液设备-第10部分:压力输液设备一次性使用的流体管线附件Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment

ISO80601-2-90:2021 医用电气设备.第2-90部分:呼吸高流量治疗设备基本安全和基本性能的特殊要求 Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment

ISO80601-2-74:2026 医用电气设备第2-74部分:呼吸湿化设备��基本安全和基本性能专用要求Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

ISO80601-2-74:2021 医疗电气设备 - 第2-74部分:呼吸加湿设备的基本安全和基本性能的特殊要求Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

ISO80601-2-70:2015 医疗电气设备 - 第2-70部分:睡眠呼吸暂停治疗设备的基本安全和基本性能的特殊要求Medical Electrical Equipment -- Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

ISO80601-2-69:2020 医用电气设备第2-69部分:氧气浓缩器的基本安全和基本性能专用要求 Medical electrical equipment-Part 2-69:Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

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ISO80601-2-67:2026 医用电气设备第2-67部分:氧气保存设备基本安全和基本性能的专用要求Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

ISO80601-2-61:2017 医用电气设备第2-61部分:脉搏血氧设备的基本安全和基本性能专用要求 Medical electrical equipment-Part 2-61:Particular requirements for the basic safety and essential performance of pulse oximeter equipment

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...

ISO11981:2017 眼科光学 - 隐形眼镜和隐形眼镜护理产品 - 具有隐形眼镜的隐形眼镜护理产品的物理兼容性测定Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses

ISO11979-8:2017 眼科植入物 - 眼内镜片 - 第8部分:基本要求Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements

ISO11979-6:2014 眼科植入物 - 眼内镜片 - 第6部分:保质期和运输稳定性测试Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing

ISO11979-5:2020 眼科光学人工晶状体第5 部分:生物相容性Ophthalmic implants-Intraocular lenses-Part 5:Biocompatibility

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