ISO 15189：2022版：前言

前言

（以下内容翻译工作由医疗软件网完成，转载请注明来源“医疗软件网”。）

ISO（国际标准化组织）是国家标准机构（ISO 成员机构）的全球联合会。国际标准的编制工作通常由 ISO 技术委员会进行。对已成立技术委员会的主题感兴趣的每个成员机构都有权在该委员会中派代表。与 ISO 联络的政府和非政府组织也参与了这项工作。ISO 与国际电工委员会 （IEC） 在电工标准化的所有事务上密切合作。

ISO/IEC 指令第 1 部分介绍了用于编写本文档的程序以及用于进一步维护本文档的程序。特别是，应注意不同类型的 ISO 文件所需的不同批准标准。本文档是根据 ISO/IEC 指令第 2 部分的编辑规则起草的（见 www.iso.org/directives).

请注意，本文档的某些元素可能成为专利权的主题。ISO 不负责识别任何或所有此类专利权。在文档开发过程中确定的任何专利权的详细信息将出现在引言和/或收到的专利声明的 ISO 列表中（见 www.iso.org/patents).

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有关标准的自愿性、ISO 与合格评定相关的特定术语和表达的含义，以及有关 ISO 在贸易技术壁垒 （TBT） 中遵守世界贸易组织 （WTO） 原则的信息，请参见 www.iso.org/iso/foreword.html.

本文件由 ISO/TC 212 临床实验室检测和体外诊断测试系统技术委员会与欧洲标准化委员会 （CEN） 技术委员会 CEN/TC 140 体外诊断医疗器械合作，根据 ISO 和 CEN 之间的技术合作协议（维也纳协定）编写。

第四版取消并取代了第三版 （ISO 15189：2012），后者已经过技术修订。它还取代了 ISO 22870：2016.

主要变化如下：

—与 ISO/IEC 17025：2017 保持一致，导致管理要求现在出现在文档末尾;

—之前在 ISO 22870 中的即时检测 （POCT） 要求已被纳入;

—更加重视风险管理。

有关本文档的任何反馈或问题应直接提交给用户所在的国家标准机构。这些机构的完整列表可以在 www.iso.org/members.html 中找到.

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Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 15189:2012), which has been technically revised. It also replaces ISO 22870:2016.

The main changes are as follows:

— Alignment with ISO/IEC 17025:2017 resulted in the management requirements now appearing at the end of the document;

— Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated;

— Increased emphasis on risk management.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.