prEN ISO 5649
医学实验室 实验室开发测试的设计、开发、实施和使用的概念和规范（ISO/DIS 5649:2023）

Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023)

非常抱歉，我们暂时无法提供预览，您可以试试： 免费下载 prEN ISO 5649 前三页，或者稍后再访问。

您也可以尝试购买此标准，
点击右侧 “立即购买” 按钮开始采购（由第三方提供）。

标准号

prEN ISO 5649

发布单位

欧洲标准化委员会

 

 

适用范围

The proposed standard document specifies requirements for ensuring quality, safety and performance of laboratory-developed tests (LDT). It outlines the general principles and assessment criteria by which LDT shall be designed, developed, manufactured, validated and monitored for internal use by medical laboratories. While the proposed standard follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within certain disciplines of medical laboratory testing. This document does not cover requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-in-vitro-diagnostic purposes. However, the concepts presented in this document may also be useful for these institutions. The proposed standard does not apply to the design, development and industrial production of commercially used in vitro diagnostic medical devices.

prEN ISO 5649相似标准

推荐