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 accuracy of electronic apex locator that use more than two different frequencies to determine root canal length during root canal treatment.

Zahnheilkunde - Bewegliche dentale Ausrüstung zur Anwendung in nicht-permanenten 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

Status
Published
Public Enquiry End Date
19-Mar-2020
Publication Date
11-Nov-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Oct-2020
Due Date
24-Dec-2020
Completion Date
12-Nov-2020

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SLOVENSKI STANDARD
SIST EN ISO 23402-1:2020
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
SIST EN ISO 23402-1:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 23402-1:2020
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SIST EN ISO 23402-1:2020
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.
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SIST EN ISO 23402-1:2020
EN ISO 23402-1:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 23402-1:2020
EN ISO 23402-1:2020 (E)
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.
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SIST EN ISO 23402-1:2020
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SIST EN ISO 23402-1:2020
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
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SIST EN ISO 23402-1:2020
ISO 23402‐1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 23402-1:2020
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

© ISO 2020 – All rights reserved iii
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SIST EN ISO 23402-1:2020
ISO 23402‐1:2020(E)
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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

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).
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.
iv © ISO 2020 – All rights reserved
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SIST EN ISO 23402-1:2020
ISO 23402‐1:2020(E)
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,

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 as 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 not be practical and is to 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 standardizing requirements for portable dental

equipment for use in non-permanent healthcare environments.
© ISO 2020 – All rights reserved v
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SIST EN ISO 23402-1:2020
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SIST EN ISO 23402-1:2020
INTERNATIONAL STANDARD ISO 23402‐1:2020(E)
Dentistry — Portable dental equipment for use in non‐
permanent healthcare environment —
Part 1:
General requirements
1 Scope

This document specifies general requirements and test methods for portable dental equipment for use

in non-permanent
...

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