ISO/TR 14283:2018 外科植入物 安全和性能的基本原则

标准编号：ISO/TR 14283:2018

中文名称：外科植入物 安全和性能的基本原则

英文名称：Implants for surgery — Essential principles of safety and performance

发布日期：2018-01

标准范围

ISO/TR 14283:2017为主动或非主动植入物的设计和制造提供了基本原则，以便每个植入物都能达到其预期目的。ISO/TR 14283:2017通常是指与植入物相关的仪器和其他设备。这些设备可能对安全植入和/或使用植入物有用，甚至是必不可少的。本文件适用于植入物，但也适用于相关仪器和设备，只要植入物的设计和制造旨在确保植入物与此类装置的安全组合和使用。相关仪器和设备的安全操作和使用要求包含在其他标准中。

ISO/TR 14283:2017 provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose.ISO/TR 14283:2017 is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and/or use of the implants. This document applies to implants, however, it also applies to associated instruments and equipment to the extent that the design and manufacture of the implants is intended to ensure the safe combination and use of the implants with such devices.Requirements for the safe operation and use of associated instruments and equipment are contained in other standards.

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