IEC 60601-2-39:2018 ED3

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Publication date:   Apr 6, 2018

General information

60.60 Standard published   Apr 6, 2018

IEC

TC 62/SC 62D

International Standard

11.040.99   Other medical equipment

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Scope

IEC 60601-2-39:2018 is also 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.

Life cycle

PREVIOUSLY

Revises
IEC 60601-2-39:2007 ED2

NOW

PUBLISHED
IEC 60601-2-39:2018 ED3
60.60 Standard published
Apr 6, 2018

REVISED BY

IN_DEVELOPMENT
IEC 60601-2-39 ED4