IEC 80601-2-58:2024 医用电气设备.第2-58部分:眼科手术用晶状体摘除装置和玻璃体切除装置的基本安全和基本性能的特殊要求

标准编号：IEC 80601-2-58:2024

中文名称：医用电气设备.第2-58部分:眼科手术用晶状体摘除装置和玻璃体切除装置的基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

发布日期：2024-03-06

标准范围

IEC 80601-2-58:2024作为IEC 80601-2-58:2024 RLV提供，其中包含国际标准及其红线版本，显示了与上一版本相比技术内容的所有变化。IEC 80601-2-58:2024适用于眼科手术用晶状体摘除装置和玻璃体切割装置（定义见201.3.209和201.3.217）以及可连接到该医用电气设备（以下简称ME设备）的相关附件的基本安全性和基本性能。如果一个条款或子条款特别旨在仅适用于ME设备，或仅适用于ME系统，该条款或子条款的标题和内容将如此说明。如果不是这种情况，该条款或子条款适用于相关的ME设备和ME系统。本文件范围内的医用电气设备或医用电气系统预期生理功能中固有的危害不在本文件的具体要求范围内，第7条除外。IEC 60601-1:20 05和IEC 60601 1:2005/AMD2:2020的2.13以及IEC 60601-1:20 05的8.4.1。IEC 80601-2-58:2024取消并取代2014年发布的第二版及其修正案1:20 16。本版构成技术修订版。与上一版相比，此版本包括以下重大技术变更:a)基于IEC 60601-1:20 05、IEC 60601-1:20 05/AMD1:2012和IEC 60601-1:20 05/AMD2:2020修订的本特定标准的一致性；b)更新抵押品、特定和IEC 60601-1:20 05、IEC 60601-1:20 05/AMD1:2012和IEC 60601-1:20 05/AMD2:2020参考文献，以与IEC 60601-1:20 05/AMD1:2012和IEC 60601-1:20 05/AMD2:2020的修订和其他抵押品标准保持一致；c)更新的规范性参考文献；d)在201中增加了对应用部件中颗粒物的新要求。9.5.101;e)在201.12.1.101.7中增加阴影光法；f)明确202.7.1.2中EMC要求的试验条件；g)更新表D.4参考文献，以包括IEC对符号的具体参考文献，并删除“附录AA，201.7.6.101”；h)包括一个新的附件，以解决欧洲法规(EU)2017/745（附件BB）的相关一般安全和性能要求；i)移除液化碎裂晶状体移除方法的所有参考。

IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005.
IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020;
b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards;
c) updated normative references;
d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101;
e) adding the shadow light method in 201.12.1.101.7;
f) clarify test conditions for EMC requirements in 202.7.1.2;
g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”;
h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB);
i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.

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