Hrvatski normativni dokument

HRN EN IEC 60601-2-39:2019

Medicinska električna oprema -- Dio 2-39: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke uređaja za peritonealnu hemodijalizu (IEC 60601-2-39:2018; EN IEC 60601-2-39:2019)

Oznaka: HRN EN IEC 60601-2-39:2019
Naslov (HR): Medicinska električna oprema -- Dio 2-39: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke uređaja za peritonealnu hemodijalizu (IEC 60601-2-39:2018; EN IEC 60601-2-39:2019)
Naslov (EN): Medical electrical equipment -- Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2018; EN IEC 60601-2-39:2019)
Područje primjene (EN): <span style=color:red >NEW! </span >IEC 60601-2-39:2018 is available as <a href=https://webstore.iec.ch/publication/62946 >IEC 60601-2-39:2018 RLV </a > which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. </br > </br >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.
Izdanje: 3
ICS: 11.040.99 Ostala medicinska oprema
Tehnički odbor/pododbor: TO E62, Električna oprema u medicinskoj praksi
Oznaka faze: 60.60 - HRN dostupan
Glasilo (rasprava): HZN e-Glasilo 5/2016 ()
Glasilo (objava): HZN e-Glasilo 6/2019 ()
Način prihvaćanja: pr - prihvaćanje strane norme u izvorniku
Cijena #1: Cijena: 41,00 € | Jezik: en | Cjenovni razred: G | Broj stranica: 31
Izvornik: EN IEC 60601-2-39:2019
Zamjenjuje: HRN EN 60601-2-39:2008
Zamjenjena s: HRN EN IEC 60601-2-39:2025
Direktiva/Uredba: kandidat

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