IEC 60601-2-39:2007
(Main)Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
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 second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a technical revision. Major changes since the last edition include a summary of additional essential performance requirements.
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
S'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux de dialyse péritonéale. Elle s'applique aux appareils de dialyse péritonéale destinés à être utilisés soit par le personnel médical soit sous la supervision d'experts médicaux, y compris les appareils de dialyse péritonéalemis en fonctionnement par le patient, que l'appareil de dialyse péritonéale soit utilisé dans un hôpital ou dans un environnement domestique. Cette seconde édition annule et remplace la première édition de la CEI 60601-2-39 dont elle constitue une révision technique. Les changements principaux depuis la dernière édition incluent un résumé des exigences de performances essentielles.
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IEC 60601-2-39
Edition 2.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-39: Particular requirements for basic safety and essential performance of
peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de dialyse péritonéale
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IEC 60601-2-39
Edition 2.0 2007-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-39: Particular requirements for basic safety and essential performance of
peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de dialyse péritonéale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
Q
CODE PRIX
ICS 11.040.99 ISBN 2-8318-9464-6
– 2 – 60601-2-39 © IEC:2007
CONTENTS
FOREWORD.3
201.1 Scope, object and related standards .5
201.2 Normative references.6
201.3 Terms and definitions.7
201.4 General requirements.8
201.5 General requirements for testing of PD EQUIPMENT .8
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .8
201.7 PD EQUIPMENT identification, marking and documents .8
201.8 Protection against electrical HAZARDS from PD EQUIPMENT .10
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.10
201.10 Protection against unwanted and excessive radiation HAZARDS.10
201.11 Protection against excessive temperatures and other HAZARDS.11
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.11
201.13 HAZARDOUS SITUATIONS and fault conditions.13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .13
201.15 Construction of ME EQUIPMENT .13
201.16 ME SYSTEMS .13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .13
202 Electromagnetic compatibility – Requirements and tests .13
203 General requirements for radiation protection in diagnostic X-ray equipment.14
206 Usability.14
208 * General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems.14
209 Requirements for the reduction of environmental impacts.14
210 Process requirements for the development of physiologic closed-loop
controllers .14
Annexes .15
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures.15
Annex AA (informative) Particular guidance and rationale.16
Index of defined terms used in this particular standard.17
60601-2-39 © IEC:2007 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment
FOREWORD
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International standard IEC 60601-2-39 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a
technical revision. Major changes since the last edition include a summary of additional
essential performance requirements.
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62D/555/CDV 62D/638/RVC
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
– 4 – 60601-2-39 © IEC:2007
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– should” means that compliance with a require
...
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