標準號：ISO 22523-2006
中文標準名稱：外置假肢和外部器械矯形.要求和試驗方法
英文標準名稱：External limb prostheses and external orthoses - Requirements and test methods
標準類型：C45
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.40;11.180.10
適用范圍：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.