IEC 60601-2-31:2020 医疗电气设备 - 第2-31部分:具有内部电源的外部心脏起搏器的基本安全性和基本性能的特殊要求

标准编号：IEC 60601-2-31:2020

中文名称：医疗电气设备 - 第2-31部分:具有内部电源的外部心脏起搏器的基本安全性和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

发布日期：2020-01-17

标准范围

IEC 60601-2-31:2020作为IEC 60601-2-31:2020 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 60601-2-31:2020适用于由内部电源供电的外部起搏器（以下简称ME设备）的基本安全性和基本性能。本文件适用于201.3.209中定义的患者电缆，但不适用于201.3.206中定义的电极导线。除通用标准7.2.13和8.4.1外，本文件中的具体要求未涵盖本文件范围内ME设备预期生理功能中固有的危害。本文件不适用于ISO 14708涵盖的有源植入式医疗器械的植入部件-1.本文件不适用于可直接或间接连接到电源的外部起搏器。本文件不适用于经胸和食管起搏ME设备和抗心动过速ME设备。IEC 60601-2-31:2020取消并取代2008年发布的第二版和修正案1:20 11。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)取消了能量减少测试的要求；b)体外除颤暴露试验已完全修订；c)取消了仅针对空气放电测试ESD抗扰度的排除；d)与最新版的起搏器ISO 14708-2以及相关EMC标准ISO 14117保持一致；e)所有变更的附加理由。

IEC 60601-2-31:2020 is available as IEC 60601-2-31:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) The requirement for testing for energy reduction has been removed;
b) The test for exposure to external defibrillation has been completely revised;
c) The exclusion for testing ESD immunity only with respect to air discharges has been removed;
d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117;
e) Additional rationale for all changes.

标准预览图