非主动外科植入物 关节置换植入物 膝关节置换植入物的特殊要求

[中文适用范围]： 本文件规定了膝关节置换植入物的要求。关于安全性，本文件规定了预期性能、设计属性、材料、设计评估、制造、灭菌、包装、制造商提供的信息和测试方法的要求。本文件适用于全膝关节置换植入物和部分膝关节置换植入物。它适用于这些带有或不带有髌股关节置换的植入物。它适用于由金属和非金属材料制成的组件。本文件适用于各种膝关节置换植入物，但对于某些特定的膝关节置换植入物类型，本文件未具体涵盖的一些注意事项可能适用。更多详细信息请参见 7.2.1.2。本文件中规定的要求并非旨在要求重新设计或重新测试已合法上市且具有充分和安全临床使用历史的植入物。对于此类植入物，可以通过提供植入物充分且安全的临床使用证据来证明其符合本文件的规定。 [外文原描述]： This document specifies requirements for knee-joint replacement implants. Regarding 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 knee joint replacement implants. It applies to these replacements both with and without the replacement of the patella-femoral joint. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of knee replacement implants, but for some specific knee 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.