C45 体外循环、人工脏器、假体装置 标准查询与下载

DIN EN ISO 25539-1:2018 心血管植入物.心血管装置.第1部分:心血管假体(ISO 25539-1-2017);德文版本EN ISO 25539-1-2017

Part 1 of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630. This International Standard is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. This International Standard is in addition applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017

YY/T 1598-2018 组织工程医疗器械产品 骨 用于脊柱融合的外科植入物的骨修复或再生评价试验指南

Tissue Engineering Medical Device Products Bone Test Guidelines for Evaluation of Bone Repair or Regeneration of Surgical Implants for Spinal Fusion

YY/T 1545-2017 血液透析用浓缩物与血液透析设备连接的评价

本标准规定了透析浓缩液、透析粉等血液透析用浓缩物与血液透析设备连接的评价方法。本标准适用于血液透析浓缩物及血液透析设备的生产、销售或使用方针对其所提供的连接方式的评价

Evaluation of concentrates for hemodialysis in connection with hemodialysis equipment

YY 0645-2018 连续性血液净化设备

Continuous blood purification equipment

DB45/T 1644-2017 假肢装配机构假肢配置路径的制定与实施

Formulation and implementation of prosthetic configuration path in prosthetic assembly mechanism

ISO 8637-1:2017 血液净化体外循环系统.第1部分:血液透析器，血液透析过滤器，血液过滤器和血液浓缩器

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to: — extracorporeal blood circuits; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — pressure monitors for the extracorporeal blood circuit; — air detection devices; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; — reprocessing procedures and equipment. NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

YY/T 1553-2017 心血管植入物 心脏封堵器

本标准的适用范围包括经导管植入的用于治疗心脏缺损等病变的心脏封堵器，主要包括房间隔缺损封堵器、室间隔缺损封堵器、动脉导管未闭封堵器及卵圆孔未闭封堵器。 本标准在基于当前医学知识水平的前提下规定了对心脏封堵器的要求。关于安全性，本标准在预期性能、设计属性、材料、设计评价、制造、灭菌包装及制造商提供信息方面提出了要求。 本标准适用于作为心脏封堵器释放组成部分的输送系统。 本标准不包括生物可吸收及聚合物产品和涂层的降解以及其他时间依从性方面的内容。 本标准不包括用于心脏封堵器系统植入前的程序和器械，如J型导丝及测量球囊等。 本标准不包括用于左心耳封堵的器械。 除灭菌以外，本标准不包括动物组织产品评价方面的要求。 YY/T 0640-2016规定了无源外科植入物性能的通用要求，本标准可视为对YY/T 0640-2016的补充。

Cardiovascular implants.Cardiac occluder

DIN EN ISO 25539-1:2017 心血管植入物.心血管装置.第1部分:心血管假体(ISO 25539-1-2017);德文版本EN ISO 25539-1-2017

Part 1 of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630. This International Standard is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. This International Standard is in addition applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017

YY/T 1574-2017 组织工程医疗器械产品 海藻酸盐凝胶固定或微囊化指南

本标准规定了海藻酸盐凝胶固定或微囊化评价的要求，包括海藻酸盐凝胶固定或微囊化、微胶囊或微胶珠的性能及其考察、海藻酸盐凝胶的生物相容性的考察。 本标准适用于海藻酸盐凝胶固定或微囊化的评价。

Tissue engineering medical device products.Standard guide for immobilization or encapsulation in alginate gels

YY/T 1576-2017 组织工程医疗器械产品 可吸收材料植入试验

Tissue engineering medical device product absorbable material implantation test

YY/T 1577-2017 组织工程医疗器械产品 聚合物支架微结构评价指南

Guidelines for Microstructural Evaluation of Polymer Scaffolds for Tissue Engineering Medical Device Products

YY/T 1575-2017 组织工程医疗器械产品 修复和替代骨组织植入物骨形成活性的评价指南

Guidelines for evaluation of bone formation activity of tissue engineered medical device products for repairing and replacing bone tissue implants

BS EN ISO 15621:2017 尿液和/或粪便的吸收性失禁用品.通用评估指南

Absorbent incontinence aids for urine and/or faeces. General guidelines on evaluation

BS ISO 11491:2017 外科植入物. 测定髋关节假体用陶瓷股骨头的抗冲击性

Implants for surgery. Determination of impact resistance of ceramic femoral heads for hip joint prostheses

ISO 11491:2017 外科植入物. 测定髋关节假体用陶瓷股骨头的抗冲击性

This document specifies two alternative test methods for determining the impact resistance of ceramic femoral heads for hip joint prostheses.

Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses

BS ISO 19233-1:2017 外科植入物. 矫形关节假体. 利用膝关节CT数据生成三维骨模型的程序

Implants for surgery. Orthopaedic joint prosthesis. Procedure for producing parametric 3D bone models from CT data of the knee

BS ISO 18192-3:2017 外科植入物. 整个脊椎间盘假体的磨损. 不良运动学条件下腰椎假体试验的撞击磨损检测和相应环境条件

Implants for surgery. Wear of total intervertebral spinal disc prostheses. Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions

YY/T 1570-2017 组织工程医疗器械产品皮肤替代品（物）的术语和分类

Terminology and classification of skin substitutes (materials) for tissue engineering medical device products

YY/T 1571-2017 组织工程医疗器械产品透明质酸钠

Tissue engineering medical device product sodium hyaluronate

DIN EN ISO 21535:2017 非活性外科植入物.关节替代植入物.髋关节替代用植入物特殊要求(ISO 21535-2007+Amd 1-2016);德文版本EN ISO 21535-2009+A1-2016

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016); German version EN ISO 21535:2009 + A1:2016