ISO 16061:2021 与非活动外科植入物配套使用的仪器 一般要求

标准编号：ISO 16061:2021

中文名称：与非活动外科植入物配套使用的仪器 一般要求

英文名称：Instruments for use in association with non-active surgical implants — General requirements

发布日期：2021-03

标准范围

本文件规定了与非活性外科植入物相关的仪器的一般要求。这些要求适用于仪表的制造和翻新后的供应。注:在本文件中，除非另有规定，否则术语“仪器”指与非活性外科植入物相关的仪器。本文件也适用于可连接到动力驱动系统的仪器，但不适用于动力驱动系统-驱动系统本身。关于安全，本文件给出了仪器制造商（以下简称制造商）提供的预期性能、设计属性、材料、设计评估、制造、灭菌、包装和信息的要求。本文件不适用于与牙科植入物、经牙髓和经神经根植入物以及眼科植入物相关的仪器。

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.

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