ISO 22523-2006 外置假肢和外部器械矫形.要求和试验方法

标准号：ISO 22523-2006
中文标准名称：外置假肢和外部器械矫形.要求和试验方法
英文标准名称：External limb prostheses and external orthoses - Requirements and test methods
标准类型：C45
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.40;11.180.10
适用范围：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.