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微流体技术 术语 (ISO 10991:2023)（2023年11月西班牙标准化协会批准 ）

Microfluidics - Vocabulary (ISO 10991:2023) (Endorsed by Asociación Espa?ola de Normalización in November 2023.)

美国眼科国家标准 植入式青光眼装置

American National Standard for Ophthalmics - Implantable Glaucoma Devices

医疗器械生物学评价 第1部分：风险管理过程中的评价和测试

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

医疗器械生物学评价 第2部分：动物福利要求

Biological evaluation of medical devices— Part 2: Animal welfare requirements

非无菌丁腈手套牙科用美国国家标准/美国牙科协会规范 No 102

Non-sterile nitrile gloves for dental use American National Standard/American Dental Association Specification No. 102

义齿基托临时衬里树脂

Denture Base Temporary Relining Resins

牙科印模托盘

Dental Impression Trays

给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Opthalmic implants - Intraocular lenses - Vocabulary

给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Opthalmic implants - Intraocular lenses - Biocompatibility

给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Opthalmic implants - Intraocular lenses - Fundamental requirements

手术植入物 两部分加成固化有机硅弹性体

Two-part addition-cured silicone elastomer for surgical implants

给水用1/2 In.(12 mm)到2 In.(50 mm)聚乙烯-铝-聚乙烯和交联聚乙烯-铝-交联聚乙烯复合压力管

Cardiovascular implants - Tubular vascular prostheses

外科植入物用羟基磷灰石成分的标准规范

Standard Specification for Composition of Hydroxylapatite for Surgical Implants

植入材料的皮下筛选试验的标准实施规程

Standard Practice for Subcutaneous Screening Test for Implant Materials

弹性弹性铰链手指全关节植入物标准规范

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

医用聚甲醛(乙缩醛)的标准规格

Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

评估植入物用可吸收性生物材料的选择组织显影的标准实践规程

Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

采用固体材料测试血清中全补体活性的标准实施规程

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

使用鼠科动物局部淋巴结化验(LLNA)评估迟发性接触超敏反应的标准实施规程

Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

作为组织工程医疗产品(TEMPs)用外科植入物和底层原材料的I型胶原特性的标准指南

Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

作为组织工程医疗产品（TEMP）外科植入物和基质起始材料的I型胶原蛋白特性的标准指南

Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

组织工程医疗产品（TEMPs）用外科植入物和基质用I型胶原的特性的标准指南

Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

医用装置包装材料生物兼容性评定指南

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

医疗器械包装材料生物相容性评价标准指南

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

再生医学用水凝胶表征的标准指南

Standard Guide for Characterization of Hydrogels Used in Regenerative Medicine

外科植入用高纯度密实氧化铝的标准规范

Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

医用热塑性聚氨酯固体和溶液评估标准指南

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Medical Applications

医疗美利体育官网首页网址用聚乙烯塑料标准规范

Standard Specification for Polyethylene Plastics for Medical Applications

医用聚乙烯塑料标准规范

Standard Specification for Polyethylene Plastics for Medical Applications

可植入的环氧树脂电子胶囊密封材料的标准规格

Standard Specification for Implantable Epoxy Electronic Encapsulants

材料和器械生物试验方法的选择标准规范

Standard Practice for Selecting Biological Test Methods for Materials and Devices

用兔皮内注射法评价材料提取物的标准实施规程

Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

通过小鼠全身注射评估材料提取物急性全身毒性的标准实践规范

Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse

用粒状成型粉末制成的可植入聚四氟乙烯 (PTFE) 板材、管材和棒材的标准规范

Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

种植体材料短期筛选的标准实施规程

Standard Practice for Short-Term Screening of Implant Materials

硅弹性体面部植入物标准规范

Standard Specification for Silicone Elastomer Facial Implants

用于评估外科植入物的生物材料与骨骼肌和挿入物材料效应的兼容性的标准实施规程

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Insertion into Bone

医用聚碳酸酯树酯的标准规范

Standard Specification for Polycarbonate Resin for Medical Applications

F0136-用于外科植入应用的锻制钛 6 铝 4 钒 ELI（超低间隙）合金的标准规范 (UNS R56401)

F0136-Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

腐蚀与植入材料的降解

Corrosion and Degradation of Implant Materials

定量表征和硬组织应用多孔植入物的性能

Quantitative characterization and performance of porous implants for hard tissue applications

医疗保健应用中呼吸气体路径的生物相容性评估 第1部分：风险管理流程中的评估和测试

Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

一次使用消毒直肠导管

Sterile rectal catheters for single use

眼科植入物.隐形眼镜.有效期和运输稳定性

Ophthalmic implants - Intraocular lenses - Shelf-life and transport stability

眼科植入物.隐形眼镜.有效期和运输稳定性

Ophthalmic implants - Intraocular lenses - Shelf-life and transport stability

外科手术面罩.要求和试验方法

Surgical masks - Requirements and test methods

微流体学 词汇

Microfluidics. Vocabulary

医疗器械的生物学评价 风险管理流程中的评估和测试

Biological evaluation of medical devices. Evaluation and testing within a risk management process

非有源外科植入物.通用要求

Non-active surgical implants. General requirements

医疗保健应用中呼吸气体路径的生物相容性评估 风险管理流程中的评估和测试

Biocompatibility evaluation of breathing gas pathways in healthcare applications. Evaluation and testing within a risk management process

非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求

Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants

牙科学.口腔和上颌面外科中骨填充物和增加物用植入材料.技术文档内容

Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file

牙科 — 口腔颌面外科中用于骨填充和增强的植入材料 — 技术文件的内容

Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of a technical file

牙科 用于口腔颌面外科引导组织再生的膜材料 技术文件的内容

Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file

牙科 用于牙科的医疗器械生物相容性评估

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

眼科光学. 接触镜片和接触镜片护理产品. 通过兔眼视觉研究测定生物适合性

Ophthalmic optics. Contact lenses and contact lens care products. Determination of biocompatibility by ocular study with rabbit eyes

心血管植入物和体外循环系统.体外循环系统用血液/组织接触表面改质

Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems

CMA M-19 2017 医疗气体美利体育官网首页网址用材料生物相容性标准

CMA M-19 2017 Biocompatibility Standard for Materials Used in Medical Gas Equipment

外科植入物–生物兼容性–材料及器材之生物美利体育登录入口官网方法的选择(准则)

Implants for Surgery-Biocompatibility-Selection of Biological Test Methods for Materials and Devices

医疗器材生物性评估－第8部：生物测试用参考材料之选择及资格认定

Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests

非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求

Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants

牙科 用于牙科的医疗器械生物相容性评价

Dentistry – Evaluation of biocompatibility of medical devices used in dentistry

牙科 用于增材生产牙科修复体的金属粉末

Dentistry - Metallic powders for the additive production of dental restorations / Note: Date of issue 2022-07-15

非活性外科植入物 - 可注射植入物

Non-active surgical implants – Injectable implants

牙科学.牙科用医疗器械.牙科植入物

Dentistry - Medical devices for dentistry - Dental implants; German version EN 1642:2011

牙科 牙科医疗美利体育官网首页网址 牙科植入物

Dentistry - Medical devices for dentistry - Dental implants; German version EN 1642:2011

牙科 聚合物基冠和饰面材料

Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020); German version EN ISO 10477:2020

微过程工程 词汇（草案）

Microprocess Engineering Glossary (Draft)

微流体 词汇 (ISO 10991:2023)

Microfluidics - Vocabulary (ISO 10991:2023)

微流体 词汇（ISO 10991:2023）；德文版 EN ISO 10991:2023

Microfluidics - Vocabulary (ISO 10991:2023); German version EN ISO 10991:2023

医疗器械的生物学评价 第12部分：样品制备和参考材料（ISO/DIS 10993-12:2019）

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO/DIS 10993-12:2019); German and English version prEN ISO 10993-12:2019

医疗器械的生物学评价 第1部分：风险管理过程中的评价和测试（ISO/DIS 10993-1:2017）

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017

医疗器械的生物学评价 第2部分：动物福利要求（草案）

Biological Evaluation of Medical Devices Part 2: Animal Welfare Requirements (Draft)

医疗器械生物学评价-第2部分：动物福利要求

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022

单臂操作的助步器.要求和试验方法.第4部分:三腿或多腿拐仗: 德文版本 EN ISO 11334-4:1999

Walking aids manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs; German version EN ISO 11334-4:1999

眼科植入物.眼内透镜.第5部分:生物适应性(ISO 11979-5-2006);德文版本EN ISO 11979-5-2006

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006); German version EN ISO 11979-5:2006

眼科植入物 人工晶状体 第5部分：生物相容性（ISO/DIS 11979-5:2019）

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO/DIS 11979-5:2019); German and English version prEN ISO 11979-5:2019

眼科植入物 人工晶状体 第5部分：生物相容性

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020); German version EN ISO 11979-5:2020

眼科植入物 人工晶体 第8部分：基本要求（草案）

Ophthalmic Implants and Intraocular Lenses Part 8: Basic Requirements (Draft)

眼科植入物.人工晶体.第8部分:基本要求(ISO 11979-8-2006 + Amd.1-2011);德文版本EN ISO 11979-8-2009 + A1-2011

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2009 + A1:2011

眼科植入物.人工晶体.第8部分:基本要求(ISO 11979-8-2006+Amd.1-2011);德文版本EN ISO 11979-8-2015

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011); German version EN ISO 11979-8:2015

非活性外科植入物 一般要求（ISO 14630:2008/DAM 1:2010）

Non-active surgical implants - General requirements (ISO 14630:2008/DAM 1:2OI0)

无源外科植入物 一般要求

Non-active surgical implants - General requirements

与无源手术植入物相关使用的器械 一般要求

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021); German version EN ISO 16061:2021

医疗保健应用中呼吸气体通路的生物相容性评估 第1部分：风险管理过程中的评估和测试（草案）

Biocompatibility assessment of respiratory gas pathways in healthcare applications Part 1: Assessment and testing during risk management (draft)

医疗保健应用中呼吸气体通路的生物相容性评估 第1部分：风险管理过程中的评估和测试（ISO 18562-1:2017）

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)

医疗保健应用中呼吸气体路径的生物相容性评估 第1部分：风险管理流程中的评估和测试

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017); German version EN ISO 18562-1:2020 / Note: To be replaced by DIN EN ISO 18562-1 (2022...

医疗保健应用中呼吸气体路径的生物相容性评估 第1部分：风险管理流程中的评估和测试

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO/DIS 18562-1:2022); German and English version prEN ISO 18562-1:2022 / Note: Date of issue 2022-11-18...

牙科 正畸锚定螺钉

Dentistry - Orthodontic anchor screws (ISO 19023:2018); German version EN ISO 19023:2018

非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求（ISO 21535:2023）

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)

非有源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求（ISO 21535:2023）

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)

牙科学 牙科器械材料 第1部分：不锈钢（草案）

Materials for Dental Instruments in Dentistry Part 1: Stainless Steel (Draft)

牙科学.口腔及颌面外科中受控制的组织再生用薄膜材料.技术文档的内容

Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004); English version of DIN EN ISO 22803:2006

牙科 用于口腔颌面外科引导组织再生的膜材料 技术文件的内容

Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004); German version EN ISO 22803:2005

天然乳胶男用避孕套 要求和试验方法（草案）

Requirements and test methods for natural latex male condoms (draft)

心血管植入物 心脏瓣膜假体 第2部分：外科手术植入的心脏瓣膜替代品（草案）

Cardiovascular Implants Heart Valve Prostheses Part 2: Surgically Implanted Heart Valve Substitutes (Draft)

心血管植入物. 心脏瓣膜假体. 第3部分: 通过经导管技术植入的心脏瓣膜替代品(ISO 5840-3-2021); 德文版 EN ISO 5840-3-2021

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021); German version EN ISO 5840-3:2021

医学牙科 牙科中使用的医疗器械的生物相容性评价 第1部分：正控制材料 (ISO 7405:2008/prA1:2012)

Medicine - Dentistry - Evaluation of the biocompatibility of medical devices used in dentistry - Part 1: Positive control materials (ISO 7405:2008/prA1:2012)

牙科 牙科用医疗器械的生物相容性评估（ISO 7405:2018，2018-12 修正版）

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)

牙科-牙科用医疗器械生物相容性评估

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018

牙科 牙科用医疗器械生物相容性评价（ISO 7405:2025）

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)

眼科光学.隐形眼镜和隐形眼镜的护理产品.通过兔眼视觉研究测定生物适合性(ISO 9394-2012).德文版本EN ISO 9394-2012

Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012); German version EN ISO 9394:2012

眼科光学 隐形眼镜和隐形眼镜护理产品 通过兔眼眼部研究测定生物相容性

Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012); German version EN ISO 9394:2012

眼科光学.接触镜.第3部分：软性接触镜

Ophthalmic optics.Contact lenses.Part 3:Soft contact lenses

硬质假眼

Hard ocular prosthesis

医疗器械生物学评价 第1部分：风险管理过程中的评价与试验

Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process

医疗器械生物学评价.第2部分：动物福利要求

Biological evaluation of medical devices.Part 2: Animal welfare requirements

医疗器械生物学评价 第6部分:植入后局部反应试验

Biological evaluation of medical devices.Part 6:Tests for local effects after implantation

医疗产品 评估医疗器械的生物效应 第11部分 一般毒性研究

Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity

医疗产品 评估生物效应的系统 一般安全要求

Medical devices. Biological impact evaluation system. General requirements for safety

俄罗斯联邦的标准化 医疗美利体育官网首页网址 医疗器械的生物学评价 第2部分：动物福利要求

Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements

医疗产品 评估医疗器械的生物效应 第10部分：刺激和致敏作用的研究

Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization

心血管植入物. 管状人造血管

Cardiovascular implants. Tubular vascular prostheses

牙科 牙科医疗器械生物相容性评价

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

牙科 用于牙科印模的弹性材料

Dentistry. Elastomeric for dental impressions.

口腔医学 牙科植入物 通用要求

Dentistry - Dental implants. General.

生物医学装置生物学评价 致突变性、致癌性和生殖及发育毒性试验

Biological evaluation of medical devices. Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.

Campos profilácticos. Requisitos y métodos de ensayo. (ISO 29942:2011, MOD)

Prophylactic dams. Requirements and test methods.

微流控 词汇

Microfluidics — Vocabulary

医疗器械的生物学评价.第11部分:身体组织毒性试验

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

医疗器械的生物学评价 第18部分：风险管理过程中医疗器械材料的化学特性

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

医疗器械生物学评价 第7部分：环氧乙烷灭菌残留量 修订1：新生儿和婴儿允许限量的适用性

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants

眼科植入物.眼内晶状体.第10部分:Phakic眼内晶状体

Ophthalmic implants - Intraocular lenses- Part 10:Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes

眼科植入物.眼内透镜.第5部分:生物相容性

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility

眼科植入物 - 眼内镜片 - 第5部分:生物相容性

Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility

眼科植入物.眼内透镜.第8部分:基本要求

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements

心血管植入物和体外系统. 离心式血液泵

Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps

牙科学.牙修复术用假牙

Dentistry - Artificial teeth for dental prostheses

牙科学.口腔和上颌面外科中骨填充物和增加物用植入材料.技术文档内容

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

外科植入物.陶瓷材料.第2部分:氧化锆增强的高纯氧化铝基复合材料

Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

牙科学. 牙科医疗器械生物相容性评估

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

牙科学.钎焊材料

Dentistry — Brazing materials

医疗器械生物学评价 第1部分：风险管理过程中的生物学安全评价要求和通用原则

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

医疗器械的生物学评估 - 第22部分:纳米材料指导

Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

医疗器械的生物学评价. 风险管理过程中生物学评价行为指南

Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

医疗器械的生物学评价.第19部分:材料的物理化学形态和地形特征

Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

手术植入物 - 可吸收金属植入物的评估标准指南

Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants

可吸收性医疗器械生物学评价第1部分:一般要求

Biological evaluation of absorbable medical devices — Part 1: General requirements

牙科铸造用金-银-钯合金

Dental casting gold-silver-palladium alloys

牙科金-银-钯合金焊料

Dental gold-silver-palladium alloy solders

牙科修复用复合树脂

Dental composite resins for restoration

非活性手术植入物 可注射植入物

Non-active surgical implants - Injectable implants

微流体动力学 解释性词典（ISO 10991:2023）

Microfluidics - Vocabulary (ISO 10991:2023)

眼科植入物 眼内透镜 第8部分：主要要求（ISO 11979-8:2017）

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

无源外科植入物 关节置换植入物 对髋关节置换植入物的特殊要求（ISO 21535:2023）

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)

口腔医学 口腔器械材料 第1部分：不锈钢（ISO 21850-1:2020）

Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)

牙科 牙科用医疗器具的生物相容性评价（ISO 7405:2025）

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)

微流体 词汇

Microfluidics - Vocabulary

微流体 词汇

Microfluidics - Vocabulary

非主动外科植入物 关节置换植入物 髋关节置换植入物的特殊要求

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

牙科 用于牙科的医疗器械生物相容性评价

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

非主动外科植入物 关节置换植入物 髋关节置换植入物的特殊要求

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

印刷电子 - 第250部分：用于穿戴式智能美利体育官网首页网址的材料技术

Printed electronics – Part 250: Material technologies required in printed electronics for wearable smart devices

医疗器械的生物学评价 在风险管理过程中进行生物学评估的指南

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

眼科植入物 人工晶状体 第8部分：基本要求（ISO 11979-8:1999 修订版）

Ophthalmic implants - intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:1999, modified)

血管内导管 无菌一次性导管 第3部分：中心静脉导管（ISO 10555-3:2013）

Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)

微流体 词汇

Microfluidics - Vocabulary (ISO 10991:2023)

眼科植入物 人工晶状体 第5部分：生物相容性（ISO 11979-5:2006）

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)

眼科植入物 眼内_lens_ 第5部分：生物相容性（ISO 11979-5:2020）

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

一次性无菌尿道导管（ISO 20696:2018）

Sterile urethral catheters for single use (ISO 20696:2018)

牙科 用于口腔和颌面外科的骨填充和增量植入材料 技术文件内容（ISO 22794:2007 2009-01-15修正版）

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)

牙科 口腔内相机（ISO 23450:2021）

Dentistry - Intraoral camera (ISO 23450:2021)

牙科 牙科用医疗器械的生物相容性评价（ISO 7405:2018）

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018)

牙科 用于牙科的医疗器械生物相容性评估（ISO 7405:2025 等同采用）

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025, IDT)

医用输液美利体育官网首页网址 第12部分：一次性使用的检查阀（ISO 8536-12:2021）

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021)

输液输血器具用 丙烯腈-丁二烯-苯乙烯共聚物（ABS）专用料

Acrylonitrile-butadiene-styrene copolymer (ABS) special material for infusion and blood transfusion equipment

医疗器械包装材料的生物学评价指南

Guide for biological evaluation of packaging materials for medical devices

外科植入物用大剂量辐照交联超高分子量聚乙烯制品

Standard guide for extensively irradiation-crosslinked ultra-high molecular weight polyethylene fabricated form for surgical implant applications

可降解医用镁合金毛细管材

Biodegradable medical magnesium alloy minitubes

一次性使用采样拭子

Disposable Swab

一次性使用无菌直肠导管

STERILE RECTAL CATHETERS FOR SINGLE USE

微流体 词汇 (ISO 10991:2023)（由西班牙标准化协会于 2023 年 10 月批准 ）

Microfluidics - Vocabulary (ISO 10991:2023) (Endorsed by Asociación Espa?ola de Normalización in October of 2023.)

医疗保健应用中呼吸气体路径的生物相容性评估 第1部分：风险管理流程中的评估和测试

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017) (Endorsed by Asociación Espa?ola de Normalización in April of 2020.)

非活性外科植入物 关节置换植入物 髋关节置换植入物的具体要求 (ISO 21535:2023)

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)

微流体 词汇

Microfluidics - Vocabulary

非主动外科植入物 关节置换植入物 髋关节置换植入物的特殊要求

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

牙科 牙科医疗美利体育官网首页网址生物相容性评估

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

后处理： 医疗器械后处理风险管理 风险控制措施

Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control

医学中的生物材料 分类、要求和应用

Biomaterials in medicine - classification@requirements and applications

Biomaterialien in der Medizin - Klassifikation@ Anforderungen und Anwendungen

Biomaterials in medicine - Classification@ requirements@ and applications

吻(缝)合器.通用技术条件

Kissing (suture) device. General technical conditions

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

一次性使用无菌直肠导管

Sterile rectal catheters for signle use

心血管植入物及人工器官 心肺转流系统 动脉管路血液过滤器

Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial blood line filter

纤维上消化道内窥镜

Upper gastro intestinal fiberscope

牙科EDTA根管润滑/清洗剂

Dental EDTA root canal lubricant/cleanser

外科植入物.金属髓内钉系统.第2部分:锁定部件

Implants for surgery.Metal intramedullary nailing system.Part 2:Locking components

输血器与血液成分相容性测定 第2部分：血液成分损伤评定

Determination of compatibility of blood transfusion sets and blood components Part 2: Assessment of blood component damage

超声探头穿刺架

Ultrasound probe puncture stand