11.100.10 标准查询与下载

prEN ISO 15194 体外诊断医疗器械 经过认证的参考材料和支持文件内容的要求（ISO/DIS 15194:2023）

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023)

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）

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.

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