标准摘要
[中文适用范围]： 本文件规定了非活性外科植入物（以下简称植入物）的一般要求。本文件不适用于牙科植入物、牙科修复材料、根管外和跨骨干植入物、眼内镜以及利用活体动物或人体组织的植入物。在安全性方面，本文件规定了预期性能、设计属性、材料、设计评估、制造、灭菌、包装以及制造商提供的信息的要求，并进行了测试以证明符合这些要求。针对特定植入物或植入物系列的附加要求在第二级和第三级标准中给出或被引用。注意1：本文件不要求制造商建立质量管理体系。然而，许多监管机构要求应用ISO 13485描述的质量管理体系来确保植入物实现其预期性能和安全性。注意2：在本文件中，除非另有说明，“植入物”一词指的是系统中的每个独立组件或模块化植入物（单独提供或作为组件组），以及所有旨在改善预期性能的辅助植入物或相关植入物。 [外文原描述]： This document specifies general requirements for non-active surgical implants, hereafter referred to as implants. This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards. NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety. NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.
英文名称Non-active surgical implants — General requirements