ISO 22523-2006 外置假肢和外部器械矫形.要求和试验方法

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                   【英文标准名称】:     External limb prostheses and external orthoses - Requirements and test methods            【原文标准名称】:     外置假肢和外部器械矫形.要求和试验方法            【标准号】:     ISO 22523-2006            【标准状态】:     现行            【国别】:     国际            【发布日期】:     2006-10    【实施或试行日期】: 【发布单位】: 国际标准化组织(IX-ISO)【起草单位】: ISO/TC 168【标准类型】: ()【标准水平】: ()【中文主题词】: 残疾人辅助器具;人造假肢;定义;设计;电气安全;人类工效学;精密机械;使用说明书;肢;载荷试验;材料;材料规范;矫形外科学;器械矫形装置;修复装置;规范(验收);材料强度;专门装备;试验【英文主题词】: Aids for the disabled;Artificial limbs;Definitions;Design;Electrical safety;EMC;Ergonomics;Fine mechanics;Information supplied by the manufacturer;Instructions for use;Limbs;Loading tests;Materials;Materials specification;Orthopaedics;Orthopedics;Orthotic devicesrosthetic devices;Resistance;Specification (approval);Sterility;Strength of materials;Surface temperatures;Technical aid;Testing【摘要】: This International Standard specifies requirements and test methods for external limb prostheses and externalorthoses, including the following classifications from ISO 9999:06 03 - 06 15 Orthoses06 18 - 06 27 Limb prosthesesIt covers strength, materials, restrictions on use, risk and the provision of information associated with thenormal conditions of use of both components and assemblies of components.This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999and it is not normally body worn.NOTE 1 It is intended to cover orthopaedic footwear (classification 06 33) in the future.NOTE 2 The application of Quality Systems as described or referred to in ISO 13485 and ISO 13488 may beappropriate.【中国标准分类号】: C45【国际标准分类号】: 11_040_40;11_180_10【页数】: 82P;A4【正文语种】: 英语