与非有源外科植入物共同使用的仪器. 一般要求

[中文适用范围]： 本文件规定了与非有源外科植入物一起使用的器械的一般要求。这些要求适用于制造的器械和翻新后提供的器械。注：在本文件中，除非另有规定，术语“器械”是指与非有源外科植入物一起使用的器械。本文件还适用于可连接到电动系统的器械，但不适用于电动系统本身。在安全方面，本文件给出了预期性能、设计属性、材料、设计评估、制造、灭菌、包装和器械制造商（以下简称制造商）提供的信息的要求。本文件不适用于与牙科植入物、经牙髓和经根尖植入物以及眼科植入物相关的器械。 [外文原描述]： This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants. This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves. With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer. This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.