Medical electrical equipment-Particular requirements for the basic safety and essential performance of infusion pumps and controllers
医用电气设备
发布日期:
2015-06-30
BS EN 60601-2-24:2015适用于输液的基本安全性和基本性能
泵和容量输液控制器,以下简称医用电气设备。本标准适用于管理装置,只要其特性影响
输液泵和容量输液的基本安全或基本性能
控制器。然而,本标准并未规定其他方面的要求或试验
如果条款或子条款专门适用于医用电气设备,或
仅适用于ME系统,该条款或子条款的标题和内容将说明这一点。如果不是这样的话
在这种情况下,本条款或子条款适用于医用电气设备和医用电气系统(视情况而定)。医用电气设备或医用电气系统预期生理功能中固有的危险
在本标准的范围内,本标准的具体要求不包括
通用标准7.2.13和8.4.1中的规定除外。交叉引用:IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-1-8:2006IEC 60601-1:2005ISO 3696:1987ISO 7864ISO 8536-4EN 60601-1-2:2007EN 60601-1-6:2010EN 60601-1-8:2007EN 60601-1:2006EN 60601-1-1:2006/A1:2013EN 60601-1:2006/A12:2014EN ISO 3696:1995EN ISO 7864EN ISO 8536-493/42/EECIEC 61000-4-2REPEN-1998。购买本文件时可获得的所有当前修订均包含在购买本文件中。
BS EN 60601-2-24:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION
PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT.This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the
BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION
CONTROLLERS. However this standard does not specify requirements or tests for other aspects
of ADMINISTRATION SETSIf 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 standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.Cross References:IEC 60601-1-2:2007IEC 60601-1-6:2010IEC 60601-1-8:2006IEC 60601-1:2005ISO 3696:1987ISO 7864ISO 8536-4EN 60601-1-2:2007EN 60601-1-6:2010EN 60601-1-8:2007EN 60601-1:2006EN 60601-1:2006/A1:2013EN 60601-1:2006/A12:2014EN ISO 3696:1995EN ISO 7864EN ISO 8536-493/42/EECIEC 61000-4-2EN 61000-4-2Replaces BS EN 60601-2-24:1998 which remains current.All current amendments available at time of purchase are included with the purchase of this document.