IEC 60335-2-125:2026

IEC 60335-2-125 ®
Edition 1.0 2026-10
INTERNATIONAL
STANDARD
Household and similar electrical appliances - Safety -
Part 2-125: Particular requirements for breast pump appliances for expressing
breast milk
ICS 97.170 ISBN 978-2-8327-1555-0

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or
by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either
IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright
or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local
IEC member National Committee for further information.

IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - IEC Products & Services Portal - products.iec.ch
webstore.iec.ch/advsearchform Discover our powerful search engine and read freely all the
The advanced search enables to find IEC publications by a publications previews, graphical symbols and the glossary.
variety of criteria (reference number, text, technical With a subscription you will always have access to up to date
committee, …). It also gives information on projects, content tailored to your needs.
replaced and withdrawn publications.
Electropedia - www.electropedia.org
The world's leading online dictionary on electrotechnology,
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published containing more than 22 500 terminological entries in English
details all new publications released. Available online and and French, with equivalent terms in 25 additional languages.
once a month by email. Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer
Service Centre: sales@iec.ch.
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirement . 8
5 General conditions for the tests . 8
6 Classification . 9
7 Marking and instructions . 9
8 Protection against access to live parts . 10
9 Starting of motor-operated appliances . 10
10 Power input and current . 10
11 Heating . 10
12 Charging of metal-ion batteries . 11
13 Leakage current and electric strength at operating temperature . 11
14 Transient overvoltages . 11
15 Moisture resistance . 12
16 Leakage current and electric strength . 12
17 Overload protection of transformers and associated circuits . 12
18 Endurance . 12
19 Abnormal operation . 12
20 Stability and mechanical hazards . 12
21 Mechanical strength . 13
22 Construction . 14
23 Internal wiring . 15
24 Components . 16
25 Supply connection and external flexible cords . 16
26 Terminals for external conductors . 16
27 Provision for earthing . 16
28 Screws and connections . 16
29 Clearances, creepage distances and solid insulation . 16
30 Resistance to heat and fire . 16
31 Resistance to rusting . 16
32 Radiation, toxicity and similar hazards . 16
Annexes . 18
Annex B (normative) Battery-operated appliances, separable batteries and detachable
batteries for battery-operated appliances . 19
Bibliography . 21

Figure 101 – Test setup overview to enable highest vacuum . 17
Figure 102 – Probe for measuring surface temperatures . 17

Table 101 – Maximum temperature rises for external accessible surfaces other than
the skin-contacting parts . 11

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Household and similar electrical appliances - Safety -
Part 2-125: Particular requirements for breast pump
appliances for expressing breast milk

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 60335-2-125 has been prepared by IEC technical committee 61: Safety of household and
similar electrical appliances. It is an International Standard.
The text of this International Standard is based on the following documents:
Draft Report on voting
61/7629/FDIS 61/7672/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
This part 2 is to be used in conjunction with the latest edition of IEC 60335-1 and its
amendments unless that edition precludes it; in that case, the latest edition that does not
preclude it is used. It was established on the basis of the sixth edition (2020) of that standard.
NOTE 1 When “Part 1” is mentioned in this standard, it refers to IEC 60335-1.
This part 2 supplements or modifies the corresponding clauses in IEC 60335-1, so as to convert
that publication into the IEC standard: Particular requirements for breast pump appliances for
expressing breast milk.
When a particular subclause of Part 1 is not mentioned in this part 2, that subclause applies as
far as is reasonable. When this standard states “addition”, “modification” or “replacement”, the
relevant text in Part 1 is to be adapted accordingly.
NOTE 2 The following numbering system is used:
– subclauses, tables and figures that are numbered starting from 101 are additional to those in Part 1;
– unless notes are in a new subclause or involve notes in Part 1, they are numbered starting from 101, including
those in a replaced clause or subclause;
– additional annexes are lettered AA, BB, etc.
NOTE 3 The following print types are used:
– requirements: in roman type;
– test specifications: in italic type;
– notes: in small roman type.
Words in bold in the text are defined in Clause 3. When a definition concerns an adjective, the adjective and the
associated noun are also in bold.
NOTE 4 The attention of National Committees is drawn to the fact that equipment manufacturers and testing
organizations can need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests.
It is the recommendation of the committee that the content of this publication be adopted for implementation nationally
not earlier than 12 months or later than 36 months from the date of publication.
A list of all parts of the IEC 60335 series, under the general title: Household and similar
electrical appliances - Safety, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
– reconfirmed,
– withdrawn, or
– revised.
INTRODUCTION
It has been assumed in the drafting of this International Standard that the execution of its
provisions is entrusted to appropriately qualified and experienced persons.
Guidance documents concerning the application of the safety requirements for appliances can
be accessed via TC 61 supporting documents on the IEC website
https://www.iec.ch/tc61/supportingdocuments
This information is given for the convenience of users of this International Standard and does
not constitute a replacement for the normative text in this standard.
This standard recognizes the internationally accepted level of protection against hazards such
as electrical, mechanical, thermal, fire and radiation of appliances when operated as in normal
use taking into account the manufacturer's instructions. It also covers abnormal situations that
can be expected in practice and takes into account the way in which electromagnetic
phenomena can affect the safe operation of appliances.
This standard takes into account the requirements of IEC 60364 as far as possible so that there
is compatibility with the wiring rules when the appliance is connected to the supply mains.
However, national wiring rules can differ.
If an appliance within the scope of this standard also incorporates functions that are covered
by another part 2 of IEC 60335, the relevant part 2 is applied to each function separately, as
far as is reasonable. If applicable, the influence of one function on the other is taken into
account.
When a part 2 standard does not include additional requirements to cover hazards dealt with in
Part 1, Part 1 applies.
NOTE 1 This means that the technical committees responsible for the part 2 standards have determined that it is
not necessary to specify particular requirements for the appliance in question over and above the general
requirements.
This standard is a product family standard dealing with the safety of appliances and takes
precedence over horizontal and generic standards covering the same subject.
NOTE 2 Horizontal publications, basic safety publications and group safety publications covering a hazard are not
applicable since they have been taken into consideration when developing the general and particular requirements
for the IEC 60335 series of standards.
An appliance that complies with the text of this standard will not necessarily be considered to
comply with the safety principles of the standard if, when examined and tested, it is found to
have other features that impair the level of safety covered by these requirements.
An appliance employing materials or having forms of construction differing from those detailed
in the requirements of this standard may be examined and tested according to the intent of the
requirements and, if found to be substantially equivalent, may be considered to comply with the
standard.
NOTE 3 Standards dealing with non-safety aspects of household appliances are:
– IEC standards published by TC 59 concerning methods of measuring performance;
– CISPR 11, CISPR 14-1 and relevant IEC 61000-3 series standards concerning electromagnetic emissions;
– CISPR 14-2 concerning electromagnetic immunity;
– IEC standards published by TC 111 concerning environmental matters.

1 Scope
This clause of Part 1 is replaced by the following.
This part of IEC 60335 deals with the safety of electric breast pump appliances for expressing
breast milk for household and similar purposes, their rated voltage being not more than 250 V,
including direct current (DC) supplied appliances and battery-operated appliances.
Appliances not intended for normal household use but that nevertheless can be a source of
danger to the public, such as appliances intended to be used outdoors and at lactation specialist
offices, are within the scope of this standard.
As far as is practicable, this standard deals with the common hazards presented by appliances
that are encountered by all persons in and around the home. However, in general, it does not
take into account:
– persons (including children) whose
• physical, sensory or mental capabilities; or
• lack of experience and knowledge
prevents them from using the appliance safely without supervision or instruction;
– children playing with the appliance.
Attention is drawn to the fact that
– for appliances intended to be used in vehicles or on-board ships or aircraft, additional
requirements can be necessary;
– in many countries additional requirements are specified by the national health authorities,
the national authorities responsible for the protection of labour and similar authorities.
This standard does not apply to
– breast pump appliances for expressing breast milk intended for medical purposes
(IEC 60601 series);
– electric appliances for massage of persons and intended for household and similar purposes
(IEC 60335-2-32);
– electric pumps for liquids for household and similar purposes (IEC 60335-2-41).
In some jurisdictions, a breast pump appliance is classified as a medical device. To avoid
confusion for users, several requirements between the different standards are aligned in this
document.
2 Normative references
This clause of Part 1 is applicable except as follows.
Addition:
IEC 61672-1, Electroacoustics - Sound level meters - Part 1: Specifications
IEC 61672-2, Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
ISO 3746, Acoustics - Determination of sound power levels and sound energy levels of noise
sources using sound pressure - Survey method using an enveloping measurement surface over
a reflecting plane
ISO 9614-1, Acoustics - Determination of sound power levels of noise sources using sound
intensity - Part 1: Measurement at discrete points
3 Terms and definitions
This clause of Part 1 is applicable except as follows.
3.1 Definitions relating to physical characteristics
3.1.9
normal operation
Addition:
Breast pump appliances are operated with the collection container assembly and vacuum
tubing, as applicable, in place and operated with the breast shield blocked and unblocked.
Note 101 to entry: Blocking of the breast shield can be done by inserting the artificial breast, with any vacuum
measuring connection point closed.
3.5 Definitions relating to types of appliances
3.5.101
body-worn appliance
portable appliance which includes operation while being worn by the user or attached to a
user’s clothing
Note 1 to entry: Worn by the user includes breast pump appliances that can be worn around the neck or shoulder,
positioned in the bra or carrying case.
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.144, modified – "Appliance" has been added to
the term, definition has been adapted for use with this standard, Note 1 to entry has been
replaced and Note 2 to entry has been deleted.]
3.5.102
breast shield
shape that fits over the nipple and the circular areas surrounding the nipple (the areola), to
facilitate the sealing of the breast to enable the vacuum to be established
3.6 Definitions relating to parts of an appliance
3.6.101
collection container
container in which breast milk is collected
[SOURCE: ISO 10079-4:2021, 3.1, modified – Definition has been adapted for use with this
standard.]
3.6.102
collection container assembly
collection container and its enclosure with connectors for suction
[SOURCE: ISO 10079-4:2021, 3.2]
3.6.103
vacuum tubing
tubing between the collection container assembly and the breast pump appliance
3.6.104
vacuum source
component or device for generating a vacuum
[SOURCE: ISO 10079-4:2021, 3.26]
3.6.105
skin-contacting part
part of a breast pump appliance that in normal use necessarily comes into physical contact with
the skin to perform its function
3.6.106
artificial breast
test specimen that simulates the shape, size, and texture of a user’s breast, that fits into the
breast shield to form a seal, to enable a vacuum
Note 1 to entry: The artificial breast can be made of silicon
...