标准摘要
[中文适用范围]： 范围内的设备 IEC 61010 的这一部分适用于用于体外诊断 (IVD) 医疗目的@的设备，包括自检 IVD 医疗目的。 IVD 医疗设备@无论单独使用还是组合使用@均由制造商用于体外检查样本@，包括源自人体的血液和组织样本@，仅或主要用于提供有关某一个体的信息以下一项或多项：生理或病理状态；或先天性异常；确定与潜在接受者的安全性和相容性；治疗措施的监测。自检 IVD 医疗设备由制造商设计供非专业人员在家庭环境中使用。注：如果全部或部分设备落入 IEC 61010 系列的一个或多个其他第 2 部分标准的范围以及本文件的范围内，则应考虑那些其他第 2 部分标准。设备不属于 IEC 61010-2-081 范围内的设备范围，除非制造商特别打算将其用于体外诊断检查。生物危害范围内包含的对象方面；危险化学物质。在分析材料的设备之外处理或操纵的方面被排除在范围之外。注：涵盖这些主题的要求是制定相关标准的委员会的责任。 [外文原描述]： 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