kSIST FprEN IEC 60601-2-39:2024

SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-39:2023
01-januar-2023
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za trebušno dializo
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and
essential performance of peritoneal dialysis equipment
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de dialyse péritonéale
Ta slovenski standard je istoveten z: prEN IEC 60601-2-39:2022
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
oSIST prEN IEC 60601-2-39:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN IEC 60601-2-39:2023

oSIST prEN IEC 60601-2-39:2023

62D/1992/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-39 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-11 2023-02-03
SUPERSEDES DOCUMENTS:
62D/1913/CD, 62D/1934A/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.

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

PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.

oSIST prEN IEC 60601-2-39:2023
62D/1992/CDV – 2 – IEC/CDV 60601-2-39:Ed. 4 © IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 6
5 Scope, object and related standards . 7
6 Normative references . 9
7 Terms and definitions . 9
8 General requirements . 11
9 General requirements for testing ME EQUIPMENT . 15
10 Classification of ME EQUIPMENT and ME SYSTEMS . 15
11 ME EQUIPMENT identification, marking and documents . 15
12 Protection against electrical HAZARDS from ME EQUIPMENT . 19
13 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
14 Protection against unwanted and excessive radiation HAZARDS . 20
15 Protection against excessive temperatures and other HAZARDS . 20
16 Accuracy of controls and instruments and protection against hazardous outputs . 23
17 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
18 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 26
19 Construction of ME EQUIPMENT . 27
20 * ME SYSTEMS . 28
21 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 29
22 202 Electromagnetic disturbances – Requirements and tests . 29
23 208 * General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
24 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 30
25 209 Requirements for environmentally conscious design . 32
26 211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
27 used in the HOME HEALTHCARE ENVIRONMENT . 33
28 Annexes . 34
29 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
30 mixtures . 35
31 Annex AA (informative) Particular guidance and rationale . 36
32 Bibliography . 48
33 Index of defined terms used in this particular standard . 49
35 Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
oSIST prEN IEC 60601-2-39:2023
IEC/CDV 60601-2-39:Ed. 4 © IEC 2022 – 3 – 62D/1992/CDV
38 INTERNATIONAL ELECTROTECHNICAL COMMISSION
39 ____________
41 MEDICAL ELECTRICAL EQUIPMENT –
43 Part 2-39: Particular requirements for basic safety and essential
44 performance of peritoneal dialysis equipment
46 FOREWORD
47 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
48 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
49 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
50 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
51 Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
52 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
53 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
54 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
55 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
56 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
57 consensus of opinion on the relevant subjects since each technical committee has representation from all
58 interested IEC National Committees.
59 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
60 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
61 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
62 misinterpretation by any end user.
63 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
64 transparently to the maximum extent possible in their national and regional publications. Any diverg ence between
65 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
66 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
67 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
68 services carried out by independent certification bodies.
69 6) All users should ensure that they have the latest edition of this publication.
70 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
71 members of its technical committees and IEC National Committees for any personal injury, property damage or
72 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
73 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
74 Publications.
75 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
76 indispensable for the correct application of this publication.
77 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
78 rights. IEC shall not be held responsible for identifying any or all such patent rights.
79 International standard IEC 60601-2-39 has been prepared by IEC subcommittee 62D:
80 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
81 practice.
82 This edition cancels and replaces the third edition of IEC 60601-2-39 published in 2018. This
83 edition constitutes a technical revision.
84 This edition includes the following significant technical changes with respect to the previous
85 edition:
86 a) update of references to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
87 1:2005/AMD2:2020, of references to IEC 60601-1-2:2014 and IEC 60601-1-
88 2:2014/AMD1:2020, of references to IEC 60601-1-6:2010, IEC 60601-1-
89 6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, of references to IEC 60601-1-
90 8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, of
91 references to IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and IEC 60601-1-
92 9:2007/AMD2:2020, of references to IEC 60601-1-10:2007, IEC 60601-1-

oSIST prEN IEC 60601-2-39:2023
62D/1992/CDV – 4 – IEC/CDV 60601-2-39:Ed. 4 © IEC 2022
93 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 and of references to
94 IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020;
95 b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601-
96 1:2005/AMD1:2012/ISH1:2021;
97 c) including the information given in the document 62D/1771A/INF regarding clause 201.11.8
98 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT;
99 d) including the information given in the document 62D/1734/INF regarding technical issues of
100 the previous edition;
101 e) including SECURITY (CYBERSECURITY) requirements;
102 f) additions related to online PD SOLUTION generation (ONLINE PD);
103 g) improvements regarding the definition of the APPLIED PART;
104 h) improvement of the essential performance requirements clause/subclauses;
105 i) improvements for labelling;
106 j) other minor technical improvements;
107 k) editorial improvements.
108 The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/xxxx/FDIS 62D/xxxx/RVD
110 Full information on the voting for the approval of this particular standard can be found in the
111 report on voting indicated in the above table.
112 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
113 In this document, the following print types are used:
114 – requirements and definitions: roman type;
115 – test specifications: italic type;
116 – informative material appearing outside of tables, such as notes, examples and references: in smaller type.
117 Normative text of tables is also in a smaller type;
118 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
119 NOTED: SMALL CAPITALS.
120 In referring to the structure of this document, the term
121 – "clause" means one of the seventeen numbered divisions within the table of contents,
122 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
123 – "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
124 subclauses of Clause 7).
125 References to clauses within this document are preceded by the term "Clause" followed by the
126 clause number. References to subclauses within this particular standard are by number only.
127 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
128 combination of the conditions is true.
129 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
130 Directives, Part 2. For the purposes of this document, the auxiliary verb:
131 – "shall" means that compliance with a requirement or a test is mandatory for compliance with
132 this document;
oSIST prEN IEC 60601-2-39:2023
IEC/CDV 60601-2-39:Ed. 4 © IEC 2022 – 5 – 62D/1992/CDV
133 – "should" means that compliance with a requirement or a test is recommended but is not
134 mandatory for compliance with this document;
135 – "may" is used to describe a permissible way to achieve compliance with a requirement or
136 test.
137 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table
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