本特殊标准适用于输液泵和容量输液控制器（以下简称医用电气设备）的基本安全和基本性能。本标准适用于影响输液泵和容量输液控制器基本安全或基本性能的给药装置。然而，本标准并未规定管理的其他方面的要求或测试。如果某一条款或子条款专门适用于医用电气设备，或仅适用于医用电气系统，则该条款或子条款的标题和内容将说明这一点。 如果情况并非如此，则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）。除通用标准第7.2.13条和第8.4.1条外，本标准的具体要求不包括本标准范围内医用电气设备或医用电气系统预期生理功能的固有危险。本标准中定义的输液泵、输液泵或输液容器的容积泵、输液泵或输液泵的特殊要求。 3.204、201.3.206、201.3.207、201.3.220、201.3.222和201.3.223。这些特殊标准不适用于以下情况:a）专门用于诊断或类似用途的设备（例如，血管造影术或由操作员永久控制或监督的其他泵）；b） 体外血液循环装置；c） 可植入设备；d） 专门用于尿动力学诊断的医用电气设备（当通过导管充满水时，测量膀胱的压力-容积关系）； e） 专门用于男性阳痿测试诊断的医用电气设备（测量注入的液体量，维持阴茎勃起所需的预设压力水平:阴茎海绵体测量术、阴茎海绵体造影术）；f） ISO 28620涵盖的设备。201.本特定标准的目的是为肠内营养泵、输液泵、门诊输液泵、注射器或容器泵、容量输液控制器和容量输液泵制定特定的基本安全和基本性能要求，如201中所定义。 3.204、201.3.206、201.3.207、201.3.220、201.3.222和201.3.223

This Particular Standard 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.This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223.These particular standard does not apply to the following:a) devices specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the OPERATOR);b) devices for extracorporeal circulation of blood;c) implantable devices;d) ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water);e) ME EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography);f) devices covered by ISO 28620. 201.The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223