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

This document provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose.
It 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.

标准预览图