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

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

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

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

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

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

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

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 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 5840-3:2024 心血管植入物 心脏瓣膜假体 第3部分：经导管技术植入的心脏瓣膜替代物

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

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 25539-4:2024 心血管植入物 血管内装置 第4部分：ISO 17327-1 对涂层血管内装置的应用

This document specifies the appropriate application of ISO 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISO 25539-1, ISO 25539-2, ISO 25539-3, ISO 12417-1 and ISO/TS 17137. The following coatings are within the scope of ISO 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO2, and non-oxide, such as amorphous silicon carbide and diamond-like carbon). This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISO 17327-1, which is specifically directed to implant coatings. This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document. This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.

Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices

GSO ISO 14708-5:2024 外科植入物 有源植入式医疗器械 第5部分：循环支持装置

This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements. NOTE 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 main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. 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. Included in the scope of this document are: — ventricular assist devices (VAD), left or right heart support; — total artificial hearts (TAH); — biventricular assist devices (biVAD); — percutaneous assist devices; — paediatric assist devices.

Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices

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 5840-2:2024 心血管植入物 心脏瓣膜假体 第2部分：手术植入的心脏瓣膜替代物

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

GSO ISO 14708-4:2024 外科植入物 有源植入式医疗器械 第4部分：植入式输液泵系统

This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products. NOTE       This document is not intended to apply to non-implantable infusion systems.

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems

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 6474-1:2024 外科植入物 陶瓷材料 第1部分：基于高纯度氧化铝的陶瓷材料

This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses. This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.

Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina