标准摘要
[中文适用范围]： 本标准适用于测量、控制和实验室用电气设备，包括体外诊断（IVD）医疗设备。它规定了体外诊断医疗设备在使用时的特殊安全要求，以确保其安全使用。本标准涵盖的设备包括电源供电和电池供电的设备。本标准应与IEC 61010-1的通用要求结合使用。本标准不适用于在特殊条件下（如存在腐蚀性或爆炸性环境）使用的设备。 [外文原描述]： IEC 61010-2-101:2018 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 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - adaptation of changes introduced by Amendment 1 of IEC 61010-1; - added tolerance for stability of AC voltage test equipment to Clause 6. This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).
英文名称Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment