C35 矫形外科、骨科器械 标准查询与下载

ISO 14708-3:2017 外科植入物.有源可植入意料装置.第3部分:可植入神经刺激器

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators

YY/T 1559-2017 脊柱植入物椎间盘假体静态及动态性能试验方法

Test methods for static and dynamic performance of spinal implants and intervertebral disc prostheses

YY/T 1565-2017 外科植入物 无损检验 铸造金属外科植入物射线照相检验

本标准规定了一种用于检测和评价铸造金属外科植入物内部缺陷的方法。

Implants for surgery.Non-destructive testing.Radiographic examination of cast metallic surgical implants

YY/T 1560-2017 脊柱植入物椎体切除模型中枕颈和枕颈胸植入物试验方法

Test methods for occipitocervical and occipitocervicothoracic implants in spinal implant corpectomy models

YY/T 1563-2017 脊柱植入物 全椎间盘假体功能、运动和磨损评价试验方法

本标准规定了评价全椎间盘假体磨损和(或)功能特性的试验方法。本标准对全椎间盘假体在功能性和运动条件下的磨损和(或)疲劳试验提供指导。 本标准适用于腰椎和颈椎假体。由于腰椎和颈椎的加载和运动情况并不一致，所以本标准对其分别阐述。 本标准不适用于部分椎间盘置换假体，如髓核置换假体或小关节置换。 本标准并不作为一个性能标准，表征待评价假体的安全性和有效性是本标准使用者的责任。 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。确立适当的安全及健康规范，以及在应用前明确管理限制的适用性，是本标准的使用者自身的责任。

Spinal implants.Test method for functional, kinematic and wear assessment of total disc prostheses

BS EN 50527-1:2016 评估携带有源植入式医疗设备的工作人员电磁场暴露情况的程序 一般的

Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices. General

ASTM F3141-17 全膝关节置换载荷情况的标准指南

4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3. 4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms. 4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation or high loading in the soft tissue constraints, whether they are represented physically or virtually. 4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions. 1.1 Motion path, load history and loading modalities all contribute to the wear, degradation and damage of implanted prosthetics. Simulating a variety of functional activities promises more realistic testing for wear and damage mode evaluation. Such activities are often called activities of daily living (ADLs). ADLs identified in the literature include walking, stair ascent and decent, sit-to-stand, stand-to-sit, squatting, kneeling, cross-legged sitting, into bath, out of bath, turning and cutting motions (1-7).2 Activities other than walking gait often involve an extended range of motion and higher imposed loading conditions which have the ability to cause damage and modes of failure other than normal wear (8-10). 1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control. 1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety......

Standard Guide for Total Knee Replacement Loading Profiles

ASTM F3018-17 评估硬-硬关节置换全髋关节置换和髋关节表面置换装置的标准指南

4.1 This document provides guidance for a range of assessments and evaluations to aid in preclinical research and device development of hard-on-hard total hip replacement and hip resurfacing devices used for the repair of musculoskeletal disorders. 4.2 The user is encouraged to use appropriate ASTM International or ISO standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on alloy fabricated forms, ceramic material samples, device components, or devices before assessment in an in vitro model. 4.3 Studies to support regulatory submissions should conform to appropriate regulatory requirements and guidelines for the development of medical devices. 4.4 Assessments with physical, chemical, mechanical, biocompatibility, and preclinical tests on hard-on-hard hip prosthesis components are not necessarily predictive of human results and therefore should be interpreted cautiously with respect to potential applicability to clinical conditions. Referenced metal-onmetal or ceramic-on-ceramic hip prosthesis publications can be found in the Bibliography section at the end of this guide for further review. 1.1 This guide covers materials and design recommendations and general test methods for the chemical, mechanical, and preclinical assessment of implantable devices with hard-on-hard articulations intended to replace a hip joint. The provided guidance is intended to encompass both Total Hip Replacement (THR) devices with stems that extend or fix within the intramedullary canal as well as Hip Resurfacing Arthroplasty (HRA) wherein only the hip articulating surfaces are replaced. There has been long term clinical experience with metal-on-metal articulating components manufactured from cobalt-288201;% chromium-68201;% molybdenum (Co28Cr6Mo) alloy (Specifications F75, F799, or F1537) or high purity alumina (ISO 6474-1) and ceramic-on-ceramic articulating components manufactured from high purity alumina (ISO 6474-1) or alumina matrix composite ceramics (ISO 6474-2). There has also been some limited clinical experience with metal (Co28Cr6Mo) on alumina matrix composite ceramic articulating components. This guide has been created based on the current understanding derived from those clinical histories. Device articulating components manufactured from other metallic alloys, ceramics or with coated or elementally modified articulating surfaces could also be evaluated with this guide. However, such materials that do not have a history of clinical use may present different risks. 1.2 This guide applies to the acetabular and femoral articulating components of hard-on-hard hip replacement devices. Acetabular components can be monoblock, or a modular component with a separate acetabular shell and acetabular liner. As stated above, articulating components have been made from Co28Cr6Mo for a metal-on-metal bearing; high purity alumina or alumina matrix composite ceramics for a ceramic-on-ceramic bearing; and Co28Cr6Mo and alumina matrix composite (ISO 6474-2) for a metal-on-ceramic bearing. Modular acetabular shells have to date been made from Ti-6Al-4V or Co28Cr6Mo. The shell is considered part of the acetabular component. Acetabular components may have external coating and/or porous structure intende......

Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices

DIN 13194:2016 医疗器械.Beyer型咬骨钳

Medical instruments - Rongeur type Beyer

DIN 13191:2016 医疗器械.Stille型咬骨钳

Medical instruments - Rongeur type Stille

DIN 13192:2016 医疗器械.Ruskin型咬骨钳

Medical instruments - Rongeur type Ruskin

DIN 13190:2016 医疗器械.Liston型截骨钳

Medical instruments - Bone cutting forceps type Liston

DIN 13193:2016 医疗器械.Luer型咬骨钳

Medical instruments - Rongeurs type Luer

BS EN ISO 7153-1:2016 手术器械 材料 金属

Surgical instruments. Materials. Metals

ISO 5832-7:2016 外科植入物. 金属材料. 第7部分: 可锻冷成型钴铬镍钼铁合金

This document specifies the characteris tics of, and corresponding test methods for, forgeable and cold- formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants . NO TE The mechanical properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy

EN ISO 5832-3:2016 外科植入物金属材料第3部分:锻造钛-6铝四钒合金(ISO 5832-3:2016)

Dieser Teil von ISO 5832 legt die Eigenschaften und die dazugehörigen Prüfverfahren für die Titanknetlegierung fest, die als Titan 6-Aluminium 4-Vanadium Legierung (Ti 6-Al 4-V Legierung) bekannt ist und zur Herstellung von chirurgischen Implantaten verwendet wird. ANMERKUNG Die mechanischen Eigenschaften einer Probe, die von einem Endprodukt aus dieser Legierung erhalten werden, müssen nicht notwendigerweise mit den Angaben in diesem Teil von ISO 5832 übereinstimmen.

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

NF S94-051-1:2016 外科植入物.金属材料.第1部分:锻造不锈钢

Implants for surgery - Metallic materials - Part 1 : wrought stainless steel

ISO 5832-3:2016 外科植入物.金属材料.第3部分:锻造钛6铝4钒合金

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy

ISO 80369-7:2016 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

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

BS ISO 7206-12:2016 外科植入物. 部分和全髋关节假体. 髋臼杯的变形试验方法

Implants for surgery. Partial and total hip joint prostheses. Deformation test method for acetabular shells