C35 矫形外科、骨科器械 标准查询与下载
共找到 1309 条与 矫形外科、骨科器械 相关的标准，共 88 页
Instrumentation for use in association with non-active surgical implants - General requirements
- ICS
- 11.040.30;11.040.40;11.040.99
- CCS
- C35
- 发布
- 2015-05
- 实施
La présente partie de I'ISO 5832 fixe les caractéristiques et les méthodes d'essai correspondantes de l'alliage à forger mis en forme à froid, à base de cobalt, de chrome, de nickel, de molybdène et de fer, à utiliser pour la fabrication des implants chirurgicaux.
Implants for surgery - Metallic materials - Part 7 : forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2015-04-25
- 实施
- 2015-04-25
Implants for Surgery—Ceramic materials—Part 2:Composite materials based on a high purity alumina matrix with zirconia reinforcemen
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2015-03-02
- 实施
- 2016-01-01
增补:本专用标准规定了适用于2.1.101所定义的带内部电源的体外心脏起搏器安全专用要求。本标准适用于2.1.104中定义的患者电缆。本标准不适用于直接或间接连到供电网的设备。本标准不适用于起搏电极或其他用于心电模拟的设备:1) 成为带其他功能的设备的内部部件;或2) 使刺激从外部通过胸腔或食道;或3) 在高速起搏上提供抗心动过速能量;或4) 提供起搏系统分析功能。双腔设备的每一腔应符合本标准的要求。
Medical electrical equipment.Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source
- ICS
- 11.040.01
- CCS
- C35
- 发布
- 2015-03-02
- 实施
- 2016-01-01
本标准规定了医用羧甲基壳聚糖原料的要求、试验方法、检验规则、包装、运输、贮存等要求。本标准适用于以壳聚糖或甲壳素为原料,经脱乙酰化、羧化、纯化而制成的医用级羧甲基壳聚糖,用于医疗器械产品。
Medical carboxymethylchitosan
- ICS
- 11.040.30
- CCS
- C35
- 发布
- 2015-03-02
- 实施
- 2016-01-01
YY 0605的本部分规定了要求具有高强度和良好耐腐蚀性的外科植入物用含氮量为0.25%~0.50%的不锈钢的特征及相应试验方法。
Implants for surgery.Metallic materials.Part 9:Wrought high nitrogen stainless steel
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2015-03-02
- 实施
- 2016-01-01
This part of ISO 13405 specifies a method for describing lower limb prosthetic components.
Prosthetics and orthotics - Classification and description of prosthetic components - Part 2: Description of lower limb prosthetic components
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2015-01
- 实施
This part of ISO 13405 specifies a method for describing upper limb prosthetic components.
Prosthetics and orthotics - Classification and description of prosthetic components - Part 3: Description of upper limb prosthetic components
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2015-01
- 实施
Prosthetics and orthotics - Classification and description of prosthetic components - Part 1: Classification of prosthetic components
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2015-01
- 实施
Implants for surgery. Ultra-high molecular weight polyethylene. Part 4. Oxidation index measurement method
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2015
- 实施
- 2016-03-01
Implants for surgery. Guidance on care and handling of orthopaedic implants
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2014-12-31
- 实施
- 2014-12-31
Prosthetics and orthotics. Vocabulary. Terms relating to limb amputation
- ICS
- 01.040.11;11.040.40
- CCS
- C35
- 发布
- 2014-11-30
- 实施
- 2014-11-30
Stationary source emissions. Quality assurance of automated measuring systems
- ICS
- 13.040.40
- CCS
- C35
- 发布
- 2014-11-30
- 实施
- 2014-11-30
This part of ISO 14243 describes a test method that specifies flexion/extension relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total kneejoint prostheses in wear-testing machines having axial load control, flexion/extension angular motion control, AP displacement control and tibial rotation control. The kinematics of this part of ISO 14243 may not be applicable to knee designs with a high degree of constraint, which could result in damage to the articulating components in the early stages of the test that would not be representative of clinical service.
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2014-11
- 实施
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012); German version EN ISO 7199:2014
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2014-11
- 实施
Implants for surgery. Wear of total hip-joint prostheses. Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2014-10-31
- 实施
- 2014-10-31
Implants for surgery. Wear of total knee-joint prostheses. Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2014-10-31
- 实施
- 2014-10-31
La présente partie de l'ISO 11979 spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intraoculaires (LIO) de chambres antérieure et postérieure.
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations
- ICS
- 11.040.70
- CCS
- C35
- 发布
- 2014-10-24
- 实施
- 2014-10-24
Implants for surgery. Metallic materials. Cobalt-chromium-molybdenum casting alloy
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2014-09-30
- 实施
- 2014-09-30
Implants for surgery. Metallic materials. Wrought titanium 6-aluminium 7-niobium alloy
- ICS
- 11.040.40
- CCS
- C35
- 发布
- 2014-09-30
- 实施
- 2014-09-30
