BS EN 60601-2-39:2008+A11:2011 - Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

BS EN 60601-2-39:2008+A11:2011

Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Status : Superseded, Withdrawn   Published : March 2009 Replaced By : BS EN IEC 60601-2-39:2019

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IEC 62790:2020 is available as

IEC 62790:2020 RLV

which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.



IEC 62790:2020 describes safety requirements, constructional requirements and tests for junction boxes up to 1 500 V DC for use on photovoltaic modules in accordance with class II of IEC 61140:2016.


This document applies also to enclosures mounted on PV-modules containing electronic circuits for converting, controlling, monitoring or similar operations. Additional requirements concerning the relevant operations are applied under consideration of the environmental conditions of the PV-modules. This document does not apply to the electronic circuits of these devices, for which other IEC standards apply. This second edition cancels and replaces the first edition published in 2014. This edition includes the following significant technical changes with respect to the previous edition:


- Modifications in normative references and terms and definitions;


- Improvement of declaration of categories for junction boxes in 4.1;


- Clarification for ambient temperature in 4.1;


- Addition of requirement to provide information concerning RTE/RTI or TI in 4.2;


- Reference to IEC 62930 instead of EN 50618 in 4.6;


- Addition of "Functional insulation" in Table 1;


- Addition of "Distance through cemented joints" in Table 3;


- Correction of procedure of process to categorize material groups (deletion of PTI) in 4.15.2.3;


- Requirement for approval of RTE/RTI or TI for insulation parts in 4.16.1 and 4.16.2;


- Change of requirements concerning electrochemical potential in 4.17.2;


- Clarification for IP-test in 5.3.4.2;


- Addition of test voltage for cemented joints in 5.3.6 and 5.3.16;


- Addition of detailled description on how to prepare the test sample for the thermal cycle test in 5.3.9.1;


- New test procedure for bypass diode thermal test (5.3.18) in accordance with MQT 18.1 of IEC 61215-2:2016;


- New test procedure for reverse overload current test in 5.3.23;


- New Figure 1 for thermal cycle test.




Standard NumberBS EN 60601-2-39:2008+A11:2011
TitleMedical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
StatusSuperseded, Withdrawn
Publication Date31 March 2009
Withdrawn Date14 August 2019
Normative References(Required to achieve compliance to this standard)EN 60601-1-10:2008, EN 60601-1-9:2008, IEC 60601-1-10:2007, EN 60601-1, IEC 60601-1-9:2007
Informative References(Provided for Information)93/42/EEC
Replaced ByBS EN IEC 60601-2-39:2019
International RelationshipsEN 62790,EN 60601-2-39:2008/A11:2011
Amended ByAmendment, March 2012
Draft Superseded By17/30355792 DC
DescriptorsSafety engineering, Current measurement, Electrical equipment, Technical documents, Leakage currents, Liquids, Equipment safety, Temperature control, Artificial kidneys, Electrical medical equipment, Pumps, Pressure, Leak tests, Electrical safety, Medical equipment, Instructions for use, Testing conditions, Dialysis, Electric shocks, Safety measures, Electronic equipment and components
ICS11.040.99
27.160
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
CommitteeCH/150/2
ISBN978 0 580 77314 3
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size1.672 MB
Price£182.00


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