标准编号：ISO 21535:2023
中文名称：无源外科植入物 关节置换植入物 髋关节置换植入物的特殊要求
英文名称：Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
发布日期：2023-07
标准范围
This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test. This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2. The requirements which are specified in this document are not intended to require the re-design or re- testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.
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