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IEC 60601-2-39 Ed. 3.0:2018 (b)
医用電気機器-第2-39部:腹膜透析機器の基礎安全及び基本性能に関する特定要求事項
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

発行年月日: 2018-04-06
状態: 有効
邦訳版: 無

規格概要
IEC 60601-2-39:2018 is available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: update of the 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 and of references and requirements to IEC 60601-1-11:2015; editorial improvements; improvement of the essential performance requirements clause/subclauses; new requirements for the interruption of the power supply.
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TC TC 62/SC 62D
ICS 11.040.99
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