prEN ISO 23402-1

SLOVENSKI STANDARD
01-maj-2025
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 1.
del: Splošne zahteve (ISO/DIS 23402-1:2025)
Dentistry - Portable dental equipment for use in non-permanent healthcare environment -
Part 1: General requirements (ISO/DIS 23402-1:2025)
Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften
Gesundheitseinrichtungen - Teil 1: Allgemeine Anforderungen (ISO/DIS 23402-1:2025)
Médecine bucco-dentaire - Équipement dentaire portatif destiné à être utilisé dans un
environnement de soins non permanent - Partie 1: Prescriptions générales (ISO/DIS
23402-1:2025)
Ta slovenski standard je istoveten z: prEN ISO 23402-1
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 23402-1
ISO/TC 106/SC 6
Dentistry — Portable dental
Secretariat: DIN
equipment for use in non‐
Voting begins on:
permanent healthcare
2025-03-28
environment —
Voting terminates on:
2025-06-20
Part 1:
General requirements
Médecine bucco-dentaire — Matériel dentaire portatif utilisable
dans des environnements de soins de santé non permanents —
Partie 1: Exigences générales
ICS: 11.060.20
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Reference number
ISO/DIS 23402-1:2025(en)
DRAFT
ISO/DIS 23402-1:2025(en)
International
Standard
ISO/DIS 23402-1
ISO/TC 106/SC 6
Dentistry — Portable dental
Secretariat: DIN
equipment for use in non‐
Voting begins on:
permanent healthcare
environment —
Voting terminates on:
Part 1:
General requirements
Médecine bucco-dentaire — Matériel dentaire portatif utilisable
dans des environnements de soins de santé non permanents —
Partie 1: Exigences générales
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 23402-1:2025(en)
ii
ISO/DIS 23402‐1:2025(en)
Contents Page
Foreword .iv
Introduction .v
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
5.2 Transport requirements .4
5.2.1 General .4
5.2.2 Grips or other handling features .4
5.2.3 Maximum mass .4
5.2.4 Maximum dimensions .4
5.2.5 Environmental exposure .4
5.2.6 Impact .4
5.2.7 Drop .4
5.2.8 Vibration .5
5.2.9 Foreign object and liquid ingress during transport .5
5.3 Assembly and disassembly requirements .5
5.4 Utility requirements .5
5.5 Operational requirements .6
5.5.1 Ambient operating conditions .6
5.5.2 Usability .6
5.5.3 Reprocessing of external surfaces .6
5.5.4 Foreign object and liquid ingress .6
6 Sampling . 6
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 60601‐1:2005, IEC 60601‐
1:2005/AMD 1:2021 and IEC 60601‐1:2005/AMD 2 . 9
Bibliography .11

iii
ISO/DIS 23402‐1:2025(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 documents 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).
...