IEC 60601-2-16:2018 医疗电气设备 - 第2-16部分:血液透析 血液过滤和除血设备基本安全和基本性能的特殊要求

标准编号：IEC 60601-2-16:2018

中文名称：医疗电气设备 - 第2-16部分:血液透析 血液过滤和除血设备基本安全和基本性能的特殊要求

英文名称：Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

发布日期：2018-04-20

标准范围

新的！IEC 60601-2-16:20 18作为IEC 60601-2-16:20 18 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 60601-2-16:20 18适用于血液透析、血液透析滤过和血液滤过设备的基本安全性和基本性能。IEC 60601-2-16:20 18未考虑使用透析液再生和中央输送系统的血液透析设备的透析液控制系统。然而，它确实考虑了这种血液透析设备关于电气安全和患者安全的特定安全要求。IEC 60601-2-16:20 18规定了血液透析设备的最低安全要求。这些器械旨在供医务人员使用，或供患者或其他受过培训的人员在医学专家的监督下使用。IEC 60601-2-16:20 18包括旨在向肾衰竭患者提供血液透析、血液透析滤过和血液滤过治疗的所有电子医疗设备。第五版取消并取代了2012年发布的第四版IEC 60601-2-16。与上一版相比，此版本包括以下重大技术变更:a)更新IEC 60601-1:20 05和IEC 60601-1:20 05/AMD1:2012的参考文献、IEC 60601-1-2:20 14的参考文献和要求、IEC 60601-1-6:20 10和IEC 60601-1-6:20 01/AMD1:2013的参考文献、IEC 60601-1-8:20 06和AMD1:2012的参考文献、IEC 60601-9:20 07和IEC 60601-9:20 07的参考文献、IEC1-10:20 07/AMD 1:20 13和IEC 60601-1-11:20 15的参考文献；b)扩大范围；(c)编辑方面的改进；d)增加抗凝剂递送手段的要求；e)其他一些小的技术变化。

NEW!IEC 60601-2-16:2018 is available as IEC 60601-2-16:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015;
b) widening of the scope;
c) editorial improvements;
d) addition of requirements for anticoagulant delivery means;
e) other few small technical changes.

标准预览图