ISO/FDIS 23402-1

Formatted: French (Switzerland)
ISO/DISFDIS 23402-1
Formatted: French (Switzerland)
ISO/TC 106/SC 6
Secretariat: DIN
Date: 2025-12-122026-02-04
Dentistry — Portable dental equipment for use in non-permanent
healthcare environments —
Part 1:
General requirements
DISFDIS stage
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ISO/DISFDIS 23402-1:20252026(en)
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Formatted: French (Switzerland)
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Published in Switzerland
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ISO/DISFDIS 23402-1:20252026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Classification . iii
General . iii
For electrically operated devices . iii
According to intended use environment . iii
According to supply sources . iii
According to exposure during transport . iii
Requirements . iii
General . iii
Transport requirements . iii
Utility requirements . iii
Operational requirements . iii
Sampling . iii
Measurement and test methods . iii
Visual inspection of the equipment . iii
Visual inspection of the documentation . iii
Manufacturer's instructions . iii
General . iii
Instructions for use . iii
Technical description . iii
Marking . iii
Marking on the equipment . iii
Marking of packaging . iii
Packaging . iii
(informative) Applicable testing methodology from IEC 60601-1:2005+AMD1:2012+AMD2:2020iii
Bibliography . iii
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Classification . 2
4.1 General . 2
4.2 For electrically operated devices . 2
4.3 According to intended use environment . 3
4.4 According to supply sources . 3
4.5 According to exposure during transport . 3
5 Requirements . 3
5.1 General . 3
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ISO/DISFDIS 23402-1:20252026(en)
5.2 Transport requirements . 4
5.3 Utility requirements . 6
5.4 Operational requirements . 6
6 Sampling . 7
7 Measurement and test methods . 7
7.1 Visual inspection of the equipment . 7
7.2 Visual inspection of the documentation . 7
8 Manufacturer's instructions . 7
8.1 General . 7
8.2 Instructions for use . 7
8.3 Technical description . 8
9 Marking . 8
9.1 Marking on the equipment . 8
9.2 Marking of packaging . 8
10 Packaging . 8
Annex A (informative) Applicable testing methodology from IEC 60601-1 . 9
Bibliography . 11

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ISO/DISFDIS 23402-1:20252026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO 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, ISO [had/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
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 6, Dental
equipment, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 23402-1:2020), which has been technically
revised.
The main changes are as follows:
— Update of 5.2.75.2.7, 5.2.85.2.8 and 5.2.95.2.9 have been updated to specify requirements for impact, drop
and vibration according to the classification for exposure during transport;
— Addition of 5.4.45.4.4, Foreign body and liquid ingress;
— Addition of has been added;
— Clause 8.3, list item e)Clause 8.3, list item e) and Clause 8.3, list item f)Clause 8.3, list item f) have been
added to include classification level for drop height and classification level for rough road transport
distance;
— Generalgeneral editorial updates have been made.
A list of all parts in the ISO 23402 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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ISO/DISFDIS 23402-1:20252026(en)
Introduction
Transportable dental equipment is used by dental professionals to provide care to patients in a variety of
settings. Because the intended use applications and intended means for transporting such equipment vary
considerably, a wide variety of transportable dental equipment is commercially available. For example, certain
transportable equipment is designed and constructed to be carried or rolled on its own wheels between rooms
within a healthcare facility, while other transportable dental equipment is made to be folded and packed to
carry over terrain which can be rugged and used in transient dental care settings which can have only limited
shelter and utility services.
Transportable equipment that can be moved from one location to another while being carried by one or more
persons is referred to as portable equipment. The term, "portable equipment," applies to equipment that can
be carried from room to room in a given facility or to remote parts of the world. This document focuses on
portable dental equipment which is specifically designed and constructed to be transported between non-
clinical environments and used by dental professionals to provide dental care in such settings, including
temporary field clinics.
Such portable dental equipment for use in non-permanent healthcare environments enables dental
professionals to provide a high standard of care to patients who do not have access to, or are not able to, travel
to traditional health care facilities. Settings in which this equipment is commonly used include military field
environments, humanitarian aid field clinics, public health outreach clinics, patient residences, long-term care
facilities, prisons, schools and workplaces.
A number of trends in health care have driven increased utilization of portable dental equipment in non-
permanent healthcare environments. Military forces use portable dental equipment in support of mobilized
forces or for humanitarian outreach. A variety of government and non-government organizations are
increasingly providing humanitarian dental care to underserved populations and populations affected by
disasters. Civilian health care workers are also increasingly providing dental services to a growing population
who are simply unable to visit traditional dental clinics due to age, disability, or income. Academic and
research bodies regularly conduct dental education programs,programmes (e.g. dentistry, dental hygiene and
dental assisting), particularly at external/off-site locations (including dentistry, dental hygiene, dental
assisting).
The transport and end-use conditions for portable dental equipment used in non-permanent healthcare
environments drive certain unique requirements which generally do not apply to portable, mobile or
stationary dental equipment used in traditional dental clinics or hospitals. Because portable equipment used
in non-permanent healthcare environments is intended to be moved between venues, and in some cases
carried over rugged terrain or in inclement conditions, it needs to be designed and constructed to be safely
transported by humans without damage, be efficiently assembled and disassembled, and deliver reliable
service at the point of use. Special consideration is given to the austerity of the environment in which the
equipment can be used and the availability and quality of utility supplies (such ase.g. electrical power, water,
compressed air). In order for the equipment to be sufficiently portable and capable of operating in extreme
conditions, certain requirements for dental equipment intended for use in traditional clinical settings may
notcan be practicalimpractical and should be reconsidered for portable dental equipment for use in non-
permanent healthcare environments. There can also be unique safety and infection control concerns to
consider.
This document is one in a series with the objective of standardizingThe ISO 23402 series aims to standardize
requirements for portable dental equipment for use in non-permanent healthcare environments.
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ISO/DISFDIS 23402-1:20252026(en)
Dentistry — Portable dental equipment for use in non-permanent
healthcare environments —
Part 1:
General requirements
1 Scope
This document specifies general requirements and test methods for portable dental equipment for use in non-
permanent healthcare environments.
Portable dental equipment within the scope of thisThis document includesapplies to portable dental units,
portable patient chairs, portable operator’s stools, portable operating lights, portable suction source
equipment, portable air compressors and other portable dental equipment in instances where these devices
are designed and constructed to be transported for use in non-permanent healthcare environments.
NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare
environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (such ase.g. headlamps
and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-
permanent healthcare environments or not designed to be disassembled, folded or packed for human
transport between non-permanent healthcare environments. Also, requirementsRequirements for stationary
dental equipment that can be installed in a dental mobile medical facility (e.g.,. vehicular or containerized
mobile dental clinic) are not considered in this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 4180:2019, Packaging — Complete, filled transport packages — General rules for the compilation of
performance test schedules
ISO 4180, Packaging — Complete, filled transport packages — General rules for the compilation of performance
test schedules
ISO 9687, Dentistry — Graphical symbols for dental equipment
ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part
1: General requirements
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance to chemical
disinfectants
IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
ISO/DISFDIS 23402-1:20252026(en)
IEC 80601-2-60, Medical electrical equipment — Part 2-60: Particular requirements for the basic safety and
essential performance of dental equipment
IEC 60529:1989+AMD 1:1999+AMD2:2013, Degrees of protection provided by enclosures (IP Code)
IEC 60601 1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1 and ISO 1942 as well as the
following apply.
ISO and IEC maintain terminologicalterminology databases for use in sta
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