EN ISO 23402-1:2020
(Main)Dentistry - Portable dental equipment for use in non‐permanent healthcare environment - Part 1: General requirements (ISO 23402-1:2020)
Dentistry - Portable dental equipment for use in non‐permanent healthcare environment - Part 1: General requirements (ISO 23402-1:2020)
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 this document includes 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 as 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, requirements 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.
Zahnheilkunde - Tragbare dentale Ausrüstung zur Anwendung in nicht-dauerhaften Gesundheitseinrichtungen - Teil 1: Allgemeine Anforderungen (ISO 23402-1:2020)
Dieses Dokument enthält allgemeine Anforderungen an und Prüfverfahren für tragbare dentale Ausrüstungen, die in nicht-dauerhaften Gesundheitseinrichtungen verwendet werden.
Tragbare dentale Ausrüstung im Anwendungsbereich dieses Dokuments umfasst tragbare dentale Behandlungseinheiten, tragbare Patientenliegen, tragbare Arbeitsstühle, tragbare Behandlungsleuchten, tragbare Saugausrüstung, tragbare Luftkompressoren und andere tragbare dentale Ausrüstung, sofern diese Ausrüstung für den Transport und zur Anwendung in nicht-dauerhaften Gesundheitseinrichtungen entwickelt und konstruiert wurde.
ANMERKUNG Besondere Anforderungen an bestimmte Typen tragbarer dentaler Ausrüstung zur Anwendung in nicht dauerhaften Gesundheitseinrichtungen werden in den folgenden Teilen dieses Dokuments beschrieben.
Dieses Dokument gilt nicht für fest installierte dentale Ausrüstung, am Körper tragbare Ausrüstung (wie Stirnlampen und Lupen), mobile dentale Ausrüstung oder tragbare dentale Ausrüstung, die nicht für die Anwendung in nicht dauerhaften Gesundheitseinrichtungen vorgesehen ist oder nicht dafür entwickelt wurde, für den menschlichen Transport zwischen nicht-dauerhaften Gesundheitseinrichtungen auseinandergebaut, zusammengefaltet oder verpackt zu werden. Zudem werden Anforderungen an fest installierte dentale Ausrüstung, die in einer mobilen zahnärztlichen Einrichtung (z. B. mobile Zahnklinik in einem Fahrzeug oder einem Container) verbaut werden kann, in diesem Dokument nicht berücksichtigt.
Médecine bucco-dentaire - Matériel dentaire portatif utilisable dans des environnements de soins de santé non permanents - Partie 1: Exigences générales (ISO 23402-1:2020)
Le présent document spécifie les exigences générales et les méthodes d'essai applicables au matériel dentaire portatif utilisable dans des environnements de soins de santé non permanents.
Le matériel dentaire portatif du domaine d'application du présent document comprend les units dentaires portatifs, les fauteuils portatifs pour patients, les tabourets portatifs pour opérateurs, les lampes d'opération portatives, le matériel d'aspiration portatif, les compresseurs d'air portatifs et d'autres matériels dentaires portatifs dans les cas où ces dispositifs sont conçus et fabriqués pour être transportés en vue d'une utilisation dans des environnements de soins de santé non permanents.
NOTE Les exigences particulières applicables aux types spécifiques de matériel dentaire portatif utilisable dans des environnements de soins de santé non permanents sont indiquées dans les parties ultérieures du présent document.
Le présent document ne s'applique pas au matériel dentaire fixe, au matériel de poche (tel que les lampes frontales et les loupes), le matériel dentaire mobile ou le matériel dentaire portatif qui n'est pas destiné à être utilisé dans des environnements de soins de santé non permanents ou qui n'est pas conçu pour être démonté, plié ou rangé pour être transporté par des hommes entre des environnements de soins de santé non permanents. De plus, les exigences relatives au matériel dentaire fixe qui peut être installé dans un établissement médical dentaire mobile (par exemple, clinique dentaire mobile dans un véhicule ou un conteneur) ne sont pas abordées dans le présent document.
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 1. del: Splošne zahteve (ISO 23402-1:2020)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2020
Zobozdravstvo - Prenosna dentalna oprema za začasno zdravstveno oskrbo - 1.
del: Splošne zahteve (ISO 23402-1:2020)
Dentistry - Portable dental equipment for use in non‐permanent healthcare environment
- Part 1: General requirements (ISO 23402-1:2020)
Zahnheilkunde - Bewegliche dentale Ausrüstung zur Anwendung in nicht-permanenten
Gesundheitseinrichtungen - Teil 1: Allgemeine Anforderungen (ISO 23402-1:2020)
Médecine bucco-dentaire - Matériel dentaire portatif utilisable dans des environnements
de soins de santé non permanents - Partie 1: Exigences générales (ISO 23402-1:2020)
Ta slovenski standard je istoveten z: EN ISO 23402-1:2020
ICS:
11.060.20 Zobotehnična oprema Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23402-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Portable dental equipment for use in non-
permanent healthcare environment - Part 1: General
requirements (ISO 23402-1:2020)
Médecine bucco-dentaire - Matériel dentaire portatif Zahnheilkunde - Bewegliche dentale Ausrüstung zur
utilisable dans des environnements de soins de santé Anwendung in nicht-permanenten
non permanents - Partie 1: Exigences générales (ISO Gesundheitseinrichtungen - Teil 1: Allgemeine
23402-1:2020) Anforderungen (ISO 23402-1:2020)
This European Standard was approved by CEN on 3 October 2020.
CEN 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 CEN-CENELEC Management Centre or to any CEN
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 CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23402-1:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 23402-1:2020) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2021, and conflicting national standards shall be
withdrawn at the latest by April 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 23402-1:2020 has been approved by CEN as EN ISO 23402-1:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 23402‐1
First edition
2020-09
Dentistry — Portable dental
equipment for use in non‐permanent
healthcare environment —
Part 1:
General requirements
Médecine bucco-dentaire — Matériel dentaire portatif utilisable dans
des environnements de soins de santé non permanents —
Partie 1: Exigences générales
Reference number
ISO 23402-1:2020(E)
©
ISO 2020
ISO 23402‐1:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2020 – All rights reserved
ISO 23402‐1:2020(E)
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 . 2
4.4 According to supply sources . 3
4.5 According to transport conditions . 3
5 Requirements . 3
5.1 General . 3
5.2 Transport requirements . 3
5.2.1 General. 3
5.2.2 Grips or other handling devices. 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 . 4
5.2.9 Particulate and liquid ingress during transport . 4
5.2.10 Flammability . 5
5.3 Assembly and disassembly requirements . 5
5.4 Utility requirements . 5
5.5 Operational requirements . 5
5.5.1 Ambient operating conditions . 5
5.5.2 Usability . 5
5.5.3 Applied parts not intended to supply heat to a patient . 5
5.5.4 Cleaning and disinfection of external surfaces . 6
5.5.5 Noise . 6
6 Sampling . 6
7 Measurement and test methods . 6
7.1 Visual inspection of the device . 6
7.2 Visual inspection of the documentation . 6
8 Manufacturer's instructions . 6
8.1 General . 6
8.2 Instructions for use . 7
8.3 Technical description . 7
9 Marking . 7
9.1 Marking on the equipment . 7
9.2 Marking of packaging . 7
10 Packaging . 8
Annex A (informative) Applicable testing methodology from IEC 60601‐1:2005/Amd 1:2012 .9
© IS
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