EN ISO 9873:2019
(Main)Dentistry - Intra-oral mirrors (ISO 9873:2019)
Dentistry - Intra-oral mirrors (ISO 9873:2019)
This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity.
In addition, specific requirements for metallic casing and metallic handles are given.
Zahnheilkunde - Intraoralspiegel (ISO 9873:2019)
Dieses Dokument legt Anforderungen und Prüfverfahren für wiederverwendbare Intraoralspiegel mit einer Glasschicht als Reflexionsfläche zur dentalen Anwendung in der Mundhöhle fest.
Zusätzlich werden spezifische Anforderungen an Metallgehäuse und Metallgriffe angegeben.
Médecine bucco-dentaire - Miroirs endobuccaux (ISO 9873:2019)
Le présent document spécifie les exigences et les méthodes d'essai relatives aux miroirs endobuccaux réutilisables pourvus d'une surface de verre revêtue d'une couche réfléchissante, utilisés pour le travail en bouche en médecine bucco-dentaire.
Des exigences spécifiques pour les boîtiers et les manches en métal sont également données.
Zobozdravstvo - Intraoralna ogledala (ISO 9873:2019)
Ta dokument določa zahteve in preskusne metode za intraoralna ogledala za vnovično uporabo s prevlečeno
stekleno odsevno površino, ki se uporabljajo v zobozdravstvu za posege v ustni votlini.
Podane so tudi posebne zahteve za kovinsko ohišje in kovinske ročaje.
General Information
Relations
Overview
EN ISO 9873:2019 - Dentistry - Intra‑oral mirrors (ISO 9873:2019) is an international/CEN standard that specifies requirements and test methods for reusable intra‑oral mirrors used in dentistry. The scope covers mirrors with a coated glass reflecting surface and includes specific requirements for metallic casings and metallic handles. This fourth edition (2019) supersedes EN ISO 9873:2017 and incorporates minor revisions such as a reduced recommended maximum length and added requirements for distortion and UDI marking.
Key Topics and Requirements
The standard addresses technical and safety aspects of dental mirrors to ensure consistent performance and reprocessing safety. Major topics include:
- Dimensions and designations (Clause 4.1): overall length, mirror head size, stem/handle connection and mirror head position.
- Materials (Clause 4.2): requirements for mirror glass, metallic casing and metallic handles; compatibility with reprocessing.
- Mirror head and reflecting surfaces (Clause 4.3): casing, coated glass reflecting surface (front/back coatings), nominal magnification for concave mirrors, and distortion limits.
- Mechanical strength (Clause 4.4–4.5): casing/stem joint strength and handle design requirements to withstand clinical use.
- Resistance to reprocessing (Clause 4.6 & Clause 5.2): tests and information required to demonstrate repeated sterilization/cleaning resilience.
- Measurement and test methods (Clause 5): visual inspection, magnification determination, distortion testing, and joint strength tests.
- Marking and labelling (Clause 6): required product markings, package labelling and the addition of a UDI (Unique Device Identification) code.
Keywords: EN ISO 9873:2019, intra‑oral mirrors, dental mirrors, coated glass reflecting surface, mirror head, mirror handle, resistance to reprocessing, nominal magnification, distortion, UDI.
Applications and Who Uses This Standard
EN ISO 9873:2019 is practical for any organization involved in the lifecycle of dental mirrors:
- Manufacturers - product design, materials selection, production tolerances, test protocols and conformity evidence.
- Regulatory and quality managers - compliance with medical device requirements, labelling (UDI) and documentation for sterilization instructions.
- Procurement and purchasing teams - specification and acceptance criteria when sourcing reusable intra‑oral mirrors.
- Dental clinics and sterilization staff - understanding reprocessing limits and proper labelling/UDI for device tracking.
- Test laboratories - executing the specified test methods (magnification, distortion, joint strength, resistance to reprocessing).
Related Standards (if applicable)
EN ISO 9873:2019 references other ISO standards for thread dimensions, terminology and processing information, for example:
- ISO 1942 (Dentistry - Vocabulary)
- ISO 17664 (Processing of health care products - Manufacturer’s processing information)
- ISO screw‑thread standards used for handle connections
Using EN ISO 9873:2019 helps ensure intra‑oral mirrors meet recognized performance, safety and reprocessing requirements, supporting clinical reliability and regulatory compliance.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2019
Nadomešča:
SIST EN ISO 9873:2017
Zobozdravstvo - Intraoralna ogledala (ISO 9873:2019)
Dentistry - Intra-oral mirrors (ISO 9873:2019)
Zahnheilkunde - Intraoralspiegel (ISO 9873:2019)
Médecine bucco-dentaire - Miroirs endobuccaux (ISO 9873:2019)
Ta slovenski standard je istoveten z: EN ISO 9873:2019
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 9873
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2019
EUROPÄISCHE NORM
ICS 11.060.20 Supersedes EN ISO 9873:2017
English Version
Dentistry - Intra-oral mirrors (ISO 9873:2019)
Médecine bucco-dentaire - Miroirs endobuccaux (ISO Zahnheilkunde - Intraoralspiegel (ISO 9873:2019)
9873:2019)
This European Standard was approved by CEN on 20 March 2019.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9873:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 9873:2019) 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 November 2019, and conflicting national standards
shall be withdrawn at the latest by November 2019.
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.
This document supersedes EN ISO 9873:2017.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9873:2019 has been approved by CEN as EN ISO 9873:2019 without any modification.
INTERNATIONAL ISO
STANDARD 9873
Fourth edition
2019-03
Dentistry — Intra-oral mirrors
Médecine bucco-dentaire — Miroirs endobuccaux
Reference number
ISO 9873:2019(E)
©
ISO 2019
ISO 9873:2019(E)
© ISO 2019
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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 9873:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 Dimensions and designations . 2
4.1.1 Overall length . . 2
4.1.2 Connection between the stem and handle, if applicable . 3
4.1.3 Dimensions of mirror casing and viewing surface . 3
4.1.4 Size designation of mirror head . 3
4.1.5 Position of mirror head with respect to the stem . 4
4.2 Materials . 4
4.2.1 Mirror glass . 4
4.2.2 Mirror casing . 5
4.2.3 Mirror handle. 5
4.3 Mirror head . 5
4.3.1 Casing of mirror head . 5
4.3.2 Reflecting surfaces . 5
4.3.3 Nominal magnification . 5
4.3.4 Distortion . 6
4.4 Casing/stem joint strength . 6
4.5 Handle. 6
4.6 Resistance to reprocessing . 6
5 Measurement and test methods . 6
5.1 Visual inspection . 6
5.2 Resistance to reprocessing . 6
5.3 Determination of nominal magnification for magnifying mirrors . 6
5.3.1 Apparatus . 6
5.3.2 Procedure . 7
5.4 Distortion . 7
5.4.1 Apparatus . 7
5.4.2 Procedure . 7
5.5 Casing/stem joint strength test . 8
5.5.1 Apparatus . 8
5.5.2 Procedure . 9
6 Marking and labelling . 9
6.1 General . 9
6.2 Marking on the mirror head . 9
6.3 Marking on the mirror handle . 9
6.4 Labelling on the package .10
Bibliography .11
ISO 9873:2019(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, Denitsry, Subcommittee SC 4, Dental
instruments.
This fourth edition cancels and replaces the third edition (ISO 9873:2017), of which it constitutes a
minor revision. The main changes compared to the previous edition are as follows:
— recommendation for maximum length of intra-oral mirror has been reduced from 178 mm to
173 mm in 4.1.1;
— requirement for distortion has been added in 4.3.4;
— requirement for handle has been clarified in 4.5;
— resistance to reprocessing require
...
Frequently Asked Questions
EN ISO 9873:2019 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Intra-oral mirrors (ISO 9873:2019)". This standard covers: This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity. In addition, specific requirements for metallic casing and metallic handles are given.
This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity. In addition, specific requirements for metallic casing and metallic handles are given.
EN ISO 9873:2019 is classified under the following ICS (International Classification for Standards) categories: 11.060.20 - Dental equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 9873:2019 has the following relationships with other standards: It is inter standard links to EN ISO 9873:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 9873:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
記事タイトル：EN ISO 9873:2019 - 歯科 - 口内鏡（ISO 9873:2019） 記事内容：この文書は、口腔内で使用される、コーティングされたガラス反射面を持つ再利用可能な口内鏡の要件と試験方法を定めています。 さらに、金属ケーシングと金属ハンドルに対する特定の要件も示されています。
기사 제목: EN ISO 9873:2019 - 치과 - 구강내 거울 (ISO 9873:2019) 기사 내용: 이 문서는 구강 내부에서 치과 목적으로 사용되는 코팅된 유리 반사면이 있는 재사용 가능한 구강내 거울에 대한 요구 사항과 시험 방법을 명시합니다. 또한, 금속 케이싱과 금속 손잡이에 대한 특정 요구 사항이 제공됩니다.
The article discusses the EN ISO 9873:2019 standard, which provides requirements and test methods for intra-oral mirrors used in dentistry. These mirrors have a coated glass reflecting surface and are reusable. The standard also includes specific requirements for the metallic casing and handles of the mirrors.
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