BS EN 60601-2-39:2008

电气设备.腹膜透析设备基本安全性和必要性能的详细要求，Medical electrical equipment.
of peritoneal dialysis equipmentBS EN 60601-2-39-2008+A11-2011，BS EN 60601-2-39-
—Part 2-39: Particular requirements for basic safety andessential performance of
dialysisequipmentBS EN 60601-2-39-2008，BS EN 60601-2-39-1999，C37 BS EN 15696-2008 【标准状态】： 现行 【国别】： 英国 【发布日期】： 2009-0 【英文
BS EN 60601-2- 【英文标准名称】： Medical electrical equipment —Part 2-39: Particular
ical electrical equipment - Particular requirements for the basic safety and essential
of ultrasonic medical diagnostic and monitoring equipmentBS EN 60601-2-37-2008，BS

English version
Medical electrical equipment -
Part 2-39: Particular requirements for basic safety
and essential performance of peritoneal dialysis equipment
(IEC 60601-2-39:2007)
Appareils électromédicaux -
Partie 2-39: Exigences particulières
pour la sécurité de base
et les performances essentielles
des appareils de dialyse péritonéale
(CEI 60601-2-39:2007)
Medizinische elektrische Geräte -
Teil 2-39: Besondere Festlegungen
für die Sicherheit einschließlich
der wesentlichen Leistungsmerkmale
von Peritoneal-Dialyse-Geräten
(IEC 60601-2-39:2007)
This European Standard was approved by CENELEC on 2008-03-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
BS EN 60601-2-39:2008
Licensed CopyChinese University of Hong Kong, 11/04/2009 07:49, Uncontrolled Copy, (c) BSIEN 60601-2-39:2008 - 2 -
Foreword
The text of document 62D/555/CDV, future edition 2 of IEC 60601-2-39, prepared by SC 62D,
Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC Parallel Unique Acceptance Procedure and was approved by CENELEC as
EN 60601-2-39 on 2008-03-01.
This European Standard supersedes EN 60601-2-39:1999 + corrigendum December 1999.
Major changes since EN 60601-2-39:1999 include a summary of additional essential performance
requirements.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2008-12-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2011-03-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
In this standard, the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in 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: IN
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 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 requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.2458