范围内产品的要求和试验总结

[中文适用范围]： 本文件作为技术报告，概述了IEC 60601-2-66的要求和测试，结合IEC 60601-1的适用部分以及IEC 60601系列的配套标准。 注：IEC 60601系列包括三个级别的标准：IEC 60601-1，称为通用标准，几个IEC 60601-1-X文件，称为配套标准，以及一系列特定标准，涵盖特定类型设备的要求（IEC 60601-2-X）。 旨在帮助参与产品生命周期过程的各个群体（如设计师和供应商）在不详细研究所有相关标准文件的情况下获得基本要求的概述。表格中不包括所有但只是更常见的要求和测试。 重要的是要理解，本文档中的摘要不能作为产品需求规范或测试计划的输入，而不参考标准文件IEC 60601-2-66本身。单独使用本文档不能用于建立或评估对标准IEC 60601-2-66的合规性。 下表1中的摘要不妨碍用户阅读引用的标准以全面了解助听器和助听系统的基本安全性。 [外文原描述]： IEC TR 62809:2019 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC TR 62809:2019 provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. It is intended to assist various groups involved in the product lifecycles process - like designers and suppliers - to get an overview of the basic requirements without studying all involved standard documents in detail. The table includes not all but just the more common requirements and tests. It is crucial to understand that the summary in this document cannot serve as an input for a product requirement specification or as a test plan without consulting IEC 60601-2-66 itself. This document alone cannot be used to establish or assess compliance to IEC 60601-2-66.