测量、控制和实验室用电气设备的安全要求.第2-101部分:实验室诊断(IVD)医疗设备的特殊要求

[中文适用范围]： 此部分国际电工委员会（IEC）61010标准适用于用于体外诊断（IVD）医疗目的的设备，包括自测IVD医疗目的。IVD医疗设备，无论是单独使用还是组合使用，由制造商设计用于在体外检查样本（包括源自人体的血液和组织样本）， solely or principally 旨在提供关于以下一项或多项的信息：生理学或病理状态；先天异常；确定与潜在受者的安全性和相容性；监测治疗措施。自测IVD医疗设备由制造商设计供非专业人士在家庭环境中使用。 [外文原描述]： IEC 61010-2-101:2015 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 function, as specified in IEC Guide 104. This standard has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This second edition cancels and replaces the first edition published in 2002. It constitutes a technical revision and includes the following significant changes from the first edition, as well as numerous other changes: - excluded IEC 61010-2-081 (general laboratory equipment) from the scope. This separates IEC 61010-2-081 and IEC 61010-2-101 equipment; - updated Biohazard and Lot symbols in Table 1 in Clause 5; - added requirement for within expiration consumables and authorized representative details in Instructions for Use to Clause 5; - added requirement for gas or liquid markings and ratings to Clause 5; - added requirement to include OPERATOR instructions to deal with consumable or sample spills, jams or breakage inside equipment, disposal of hazardous waste, personal protection, RISK reduction procedures relating to flammable liquids, burns from surfaces, and loading and unloading of sample and reagents in Instructions for Use to Clause 5; - added requirement for manufacturer to provide instructions on equipment transport, storage and removal from use to Clause 5; - added normative reference ISO 18113-5 for instructions for use of self-test IVD medical equipment in Clause 5; - added requirement for OPERATOR maintenance instructions to Clause 7; - added requirements for sample zones and loading zones to Clause 7; - excluded equipment whose size and weight make unintentional movement unlikely from drop test in Clause 8; - added requirement for biohazard marking to Clause 13; - added requirement for interlock systems containing electric/electronic or programmable components to Clause 15; - added informative reference to Usability standard IEC 62366 to Clause 16; - replaced Clause 17 with requirements of ISO 14971 for RISK assessment. - Annex BB Instructions for use for self-testing IVD Medical Equipment deleted and a reference given to ISO 18113-5 in Clause 5. This publication is to be read in conjunction with IEC 61010-1:2010 .