C35 矫形外科、骨科器械 标准查询与下载

YY/T 1787-2021 心血管植入物 心脏瓣膜修复器械及输送系统

Cardiovascular implants, heart valve repair devices and delivery systems

YY/T 0988.3-2021 外科植入物涂层 第3部分：贻贝黏蛋白材料

Surgical Implant Coatings Part 3: Mussel Mucin Materials

YY/T 1782-2021 骨科外固定支架力学性能测试方法

Test method for mechanical properties of orthopedic external fixation braces

YY/T 0811-2021 外科植入物用大剂量辐射交联超高分子量聚乙烯制品

本标准涉及以满足GB/T 19701.1、GB/T 19701.2所有要求的纯树脂粉料和固化形成的高交联超高分子量聚乙烯材料(制品）。 本标准不包括只接受过气体等离子、环氧乙烷或小于40kGy剂量的电离辐射处理的超高分子量聚乙烯，即只经过常规灭菌处理的材料。 本标准仅适用于经γ射线和电子束电离辐射源大剂量辐射的UHMWPE材料。 上述制品的机械性能与其在体内性能之间的具体关系尚未确定。虽然科学家致力于聚合物特性、聚合物结构和聚合物设计之间关系的研究，但上述关系还未得到圆满解释。下述机械试验常用于评估制造程序的可重复性，适用于不同材料的比较研究。 下述警示文字仅适用于本标准第5章的试验方法部分。本标准并非试图对所涉及的所有安全问题进行阐述，即便是那些与其使用有关的安全问题。确立适当的安全及操作规范，以及在应用前明确管理 限制的适用性，是本标准用户自身的责任。

Standard guide for extensively irradiation.Crosslinked ultra-high molecular weight polyethylene fabricated forms for surgical implant applications

DIN EN ISO 5840-3:2021 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

This International Standard specifies requirements for all devices intended for implantation in human hearts as a minimally invasive implanted heart valve substitute. This International Standard is applicable to both newly developed and modified minimally invasive implanted heart

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

DIN EN ISO 5840-2:2021 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(ISO 5840-2-2021); 德文版 EN ISO 5840-2-2021

This International Standard is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. This International Standard is applicable to both newly developed and modified surgi

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021); German version EN ISO 5840-2:2021

DIN EN ISO 5840-1:2021 心血管植入物. 心脏瓣膜假体. 第1部分: 一般要求(ISO 5840-1-2021); 德文版 EN ISO 5840-1-2021

This International Standard is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of this International Standard provide specific requirements. This International Standard is applicable to both newly developed

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021); German version EN ISO 5840-1:2021

ISO 80369-7:2021 卫生保健设施中液体和气体用小口径连接器. 第7部分: 血管内或皮下应用连接器

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 NOTE 2 See Annex A. The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: — haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 applicable portion of ISO 8638 [6] referencing blood compartment ports); [5] — haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); and — infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for smallbore connectors, as specified in ISO 80369, will be included. NOTE 4 small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

YY/T 1771-2021 弯曲-自由恢复法测试镍钛形状记忆合金相变温度

Bending-free recovery method to test the phase transition temperature of nickel-titanium shape memory alloy

YY/T 1776-2021 外科植入物聚乳酸材料中丙交酯单体含量的测定

Determination of lactide monomer content in polylactic acid materials for surgical implants

YY/T 1772-2021 外科植入物 电解液中电偶腐蚀试验方法

Test methods for galvanic corrosion in electrolytes for surgical implants

ISO 16061:2021 与非有源外科植入物共同使用的仪器. 一般要求

This document specifies the general requirements for instruments to be used in association with nonactive surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. NOTE In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in association with non-active surgical implants. This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves. With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer. This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

Instruments for use in association with non-active surgical implants - General requirements

DIN 96058:2021 医疗器械. 兰格-霍曼(Lange-Hohmann)式起子和骨折复位挺子

The project defines dimensions and marking of elevators and bone levers type Lange-Hohmann, as used in surgery and public health service.

Medical instruments - Elevator and bone lever type Lange-Hohmann

T/CSBME 030-2021 定制式增材制造膝关节矫形器临床评价技术规范

本文件规定了定制式增材制造膝关节矫形器的临床评价技术规范，描述了对应的试验方法，给出了术语、定义、分类及评估要求和方法等内容。

Clinical evaluation specification of custom additive manufacturing knee orthosis

ISO 5840-3:2021 心血管植入物. 心脏瓣膜假体. 第3部分: 由经导管技术植入的心脏瓣膜假体

This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute. This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques

ASTM B848/B848M-21 粉末锻造(PF)含铁材料的标准规范

1.1?This specification covers powder forged ferrous materials fabricated by hot densification of atomized prealloyed or iron powders and intended for use as structural parts. 1.2?This specification covers powder forged parts made from the following materials: 1.2.1?Compositio

Standard Specification for Powder Forged (PF) Ferrous Materials

ABNT NBR 15723-4-2020 外科植入物 - 聚合材料 第4部分：多孔聚乙烯聚合物的要求

Implants for surgery - Polymeric materials Part 4: Requirements for porous polyethylene polymers

BS ISO 27186:2020 有源可植入医疗器械. 可植入心节律管理装置用四极连接器系统. 尺寸和试验要求

Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements

ABNT NBR 15723-3-2020 外科植入物 - 聚合材料 第3部分：聚芳醚酮（PAEK）聚合物的要求

Implants for surgery - Polymeric materials Part 3: Requirements for polyaryletherketone (PAEK) polymers

ABNT NBR 15664-7-2020 外科植入物 - 产品涂层 第7部分：磷酸钙涂层的要求

Implants for surgery - Product coating Part 7: Requirements for calcium phosphate coatings