標準號：DIN EN ISO 22523-2007
中文標準名稱：外肢假體和矯形外支架.要求和試驗方法
英文標準名稱：External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006); English version of DIN EN ISO 22523:2007-04
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：11.180.10
引用標準：ISO 8548-1;ISO 8548-2;ISO 8548-3;ISO 8549-1;ISO 8549-2;ISO 13405-1;ISO 13405-2;ISO 13405-3;ISO 15032;ISO 22675;IEC 60335-2-17;IEC 60601-1-1988;IEC 60601-1-2;IEC 61000-4-3;EN 1041;EN 50082-2;ISO 8549-3;ISO 10328;ISO 13404-2005
適用范圍：This International Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:0603-06 15 Orthoses 06 18 - 06 27 Limb prosthesesIt covers strength, materials, restrictions on use, risk and the provision of information associated with the normal 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 9999 and 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 be appropriate.