11.040.40 外科植入物、假体和矫形 标准查询与下载

GB/T 13461-1992 合成树脂小腿假肢

本标准规定了小腿截肢的成年人合成树脂小腿假肢的型号、技术要求、检验方法、检验规则及标志、包装、运输和储存。 本标准适用于小腿截肢的成年人合成树脂小腿假肢的设计、制作、装配及验收。

Synthetic resin blow knee prostheses

GB 12417-1990 外科金属植入物通用技术条件

本标准规定了外科金属植入物的技术要求、试验方法、检验规则、标记、包装和使用要求等内容。 本标准适用于外科金属植入物。

The gereral technological conditions of surgical metal implant

GB 12279-1990 人工心脏瓣膜通用技术条件

本标准规定了人工心脏瓣膜（以下简称人工瓣膜）的术语和设计、生产、试验方法及包装和标签等方面的要求。 本标准适用于所有以非人体组织材料制成的人工瓣膜。

Cardiac valve prostheses general technical specification

BS ISO 8637-3:2024 体外血液净化系统 血浆过滤器

1   Scope This document specifies requirements and test methods for plasmafilters , which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters , intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to; — extracorporeal blood circuits; — haemodialysers, haemodiafilters, haemofilters and haemoconcentrators; — haemoperfusion devices; — vascular access devices; — blood pumps; — systems or equipment intended to perform plasma separation . NOTE 1 Requirements for the extracorporeal blood circuit are specified in ISO 8637‑2. NOTE 2 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1.

Extracorporeal systems for blood purification - Plasmafilters

ISO 8637-3:2024 血液净化用体外系统第3部分:血浆过滤器

Extracorporeal systems for blood purification — Part 3: Plasmafilters

ISO 8637-1:2024 血液净化用体外系统第1部分:血液透析机、血液透析过滤器、血液过滤器和血液浓缩器

This document specifies requirements and test methods 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; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration; — reprocessing procedures and equipment. NOTE 1 Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.

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

DB42/T 2236-2024 移动障碍老年人康复辅助器具适配服务规范

Service specifications for the adaptation of rehabilitation assistive devices for elderly people with mobility impairments

DB42/T 2235-2024 增材制造患者匹配式部分足假肢应用技术规范

Technical Specifications for Application of Patient-matched Partial Foot Prostheses in Additive Manufacturing

24/30456864 DC 草案外科植入物 全肩关节假体的磨损 第1部分：磨损测试机的力和位移参数以及解剖全肩关节测试的相应环境条件……

Draft BS ISO 16436-1 Implants for surgery — Wear of total shoulder-joint prostheses - Part 1: Force and displacement parameters for wear-testing machines and corresponding environmental conditions for test of anatomic total shoulder-joint…

ASTM F1314-24 UNS S20910外科植入物用锻造氮强化22铬-13镍-5锰-2.5钼不锈钢合金棒和线材的标准规范

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought nitrogen strengthened 22chromium-13nickel-5manganese-2.5molybdenum stainless steel alloy bar and wire for surgical implants. 1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of each other, and values from the two systems shall not be combined. 1.3 Any agreement between purchaser and supplier must meet the minimum requirements of this specification. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)

BS EN ISO 5832-1:2024 用于手术的植入物 金属材料 精制不锈钢

1   Scope This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document. NOTE 2 The alloy described in this document corresponds to UNS S31673 in ASTM F138 and ASTM F139.

Implants for surgery. Metallic materials - Wrought stainless steel

BS EN ISO 5832-7:2024 用于手术的植入物 金属材料 可锻冷成型钴铬镍钼铁合金

This document specifies the characteristics of, and corresponding test methods for, forgeable and cold- formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants. those specified in this document.

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

BS ISO 5832-4:2024 用于手术的植入物 金属材料 钴铬钼铸造合金

1   Scope This document specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting alloy for use in the manufacture of surgical implants. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those given in this document.

Implants for surgery. Metallic materials - Cobalt-chromium-molybdenum casting alloy

GSO ISO 14708-3:2024 外科植入物 有源植入式医疗器械 第3部分：植入式神经刺激器

ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.

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

GSO ISO 14708-6:2024 外科植入物 有源植入式医疗器械 第6部分：用于治疗心动过速的有源植入式医疗器械（包括植入式除颤器）的特殊要求

This document specifies requirements that are applicable to implantable cardioverter defibrillators and CRT-Ds and the functions of active implantable medical devices intended to treat tachyarrhythmia. The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance. This document was designed for tachyarrhythmia pulse generators used with either endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The characteristics of the implantable pulse generator or lead shall be determined by either the appropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply. Any aspect of an active implantable medical device intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2. NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.

Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

GSO ISO 24562:2024 假肢 下肢假肢适配器的几何方面

This document specifies dimensions of the adult modular systems adapters used in lower limb prosthetic.

Prosthetics — Geometrical aspects of lower limb prosthetic adapters

GSO ISO/TR 37137:2024 医疗器械心血管生物学评价 可吸收植入物指南

The objective of ISO/TR 37137:2014 is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification.

Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants

GSO ISO 5832-14:2024 外科植入物 金属材料 第14部分：锻造钛 15-钼 5-锆 3-铝合金

This document specifies the characteristics of, and corresponding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for use in the manufacture of surgical implants. This document applies to materials in bar form up to a maximum diameter of 100 mm. NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.

Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy

GSO ISO 8551:2024 假肢和矫形器 功能缺陷 对接受矫形器治疗的人员的描述、治疗的临床目标以及矫形器的功能要求

This document establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.

Prosthetics and orthotics — Functional deficiencies — Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis

GSO ISO 25539-3:2024 心血管植入物 血管内装置 第3部分：腔静脉过滤器

ISO 25539-3:2011 specifies requirements for vena cava filters, 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. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants. The following are within the scope of ISO 25539-3:2011: vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites; sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter. delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter. optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems: while ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. The following are outside the scope of ISO 25539-3:2011: temporary filters (e.g. tethered) that need to be removed after a defined period of time; coatings, surface modifications, and/or drugs; issues associated with viable tissues and non-viable biological materials; degradation and other time-dependent aspects of absorbable materials; procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.

Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters