ISO 16635-2:2014
(Main)Dentistry — Dental rubber dam instruments — Part 2: Clamp forceps
Dentistry — Dental rubber dam instruments — Part 2: Clamp forceps
ISO 16635-2:2014 specifies requirements and test methods for clamp forceps intended for the application of dental rubber dam clamps to teeth.
Médecine bucco-dentaire — Instruments de digue dentaire en caoutchouc — Partie 2: Pinces porte-crampons
L'ISO 16635-2:2014 spécifie les exigences et méthodes d'essai relatives aux pinces porte‑crampons qui permettent de placer sur les dents des crampons pour digue dentaire en caoutchouc.
General Information
- Status
- Published
- Publication Date
- 14-Sep-2014
- Technical Committee
- ISO/TC 106/SC 4 - Dental instruments
- Drafting Committee
- ISO/TC 106/SC 4/WG 8 - Dental hand instruments
- Current Stage
- 9093 - International Standard confirmed
- Start Date
- 07-Jul-2025
- Completion Date
- 14-Feb-2026
Relations
- Consolidates
EN ISO 16635-2:2014 - Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014) - Effective Date
- 12-Feb-2026
Overview
ISO 16635-2:2014, published by the International Organization for Standardization (ISO), specifies key requirements and test methods for clamp forceps used in dental rubber dam procedures. Clamp forceps are essential dental instruments designed for the precise application of dental rubber dam clamps during restorative dental treatments. This standard ensures dental professionals use safe, reliable, and effective forceps that meet strict quality criteria, promoting best practices in dental isolation and patient care.
Key Topics
Scope and Purpose:
The standard defines the criteria for clamp forceps intended to place dental rubber dam clamps accurately and securely on teeth, supporting effective dental isolation techniques.Instrument Design:
- The clamp forceps should be crafted to avoid contact with the teeth during application.
- The working end must include angled or stepped retaining pins with a controlled insertion depth, enabling safe use and proper clamp orientation.
- Locking mechanisms are required to secure clamps both during and after placement.
Material and Surface Requirements:
- Forceps must be made from corrosion-resistant stainless steel, ensuring durability and resistance to repeated sterilization.
- Surface finishes-either brightened or matted-must be free of pores, cracks, or residues.
Dimensional and Mechanical Criteria:
- Maximum total length must be ≤ 175 mm and handle distances in the closed state ≤ 95 mm.
- Retaining pins and clamp receiver dimensions are specified for safe and effective performance.
- Spring mechanisms must return the forceps to their original closed state automatically.
Quality and Durability Testing:
- Visual inspections and precise measurement methods are mandated.
- Forceps must withstand at least 100 sterilization cycles with no signs of corrosion or functional deterioration.
Marking and Traceability:
- Each forceps must be marked with manufacturer or brand name, model/reference number, and batch/lot number for traceability.
Applications
ISO 16635-2:2014 is critical for:
Dental Device Manufacturers:
Ensuring that clamp forceps meet international standards for safety, performance, sterilization resistance, and traceability. Adherence supports certification, regulatory compliance, and global acceptance.Dental Professionals:
Providing assurance that instruments are fit for use in precise dental procedures, minimizing risk to patients and enhancing treatment isolation with dental rubber dam systems.Procurement and Quality Control:
Serving as a reference for purchasing departments to select compliant dental forceps, and for quality assurance teams to verify conformance during inspections and audits.Training and Education:
Supporting curriculum development for dental education regarding proper instrument selection and standard-based procedure implementation.
Related Standards
For a comprehensive approach to dental rubber dam instrumentation and processing, consider these related ISO standards:
ISO 16635-1: Dentistry - Dental rubber dam instruments - Part 1: Hole punch
Specifies requirements for instruments used to punch holes in rubber dam sheets.ISO 15510: Stainless steels - Chemical composition
Details the chemical composition requirements for the stainless steels used in medical and dental instruments.ISO 17664: Sterilization of medical devices - Information to be provided by the device manufacturer for the processing of reusable medical devices
Outlines sterilization and reprocessing protocol information needed for devices like clamp forceps.ISO 1942: Dentistry - Vocabulary
Provides standard terminology for dental professionals and instrument manufacturers.ISO 6507-1 and ISO 6508-1:
Set requirements for metallic materials hardness testing necessary for assessing the durability of clamp forceps.
Implementing ISO 16635-2:2014 in dental practice and manufacturing ensures optimized clinical outcomes, patient safety, and efficient processing of dental rubber dam instruments.
Buy Documents
ISO 16635-2:2014 - Dentistry — Dental rubber dam instruments — Part 2: Clamp forceps Released:9/15/2014
ISO 16635-2:2014 - Médecine bucco-dentaire — Instruments de digue dentaire en caoutchouc — Partie 2: Pinces porte-crampons Released:9/15/2014
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Frequently Asked Questions
ISO 16635-2:2014 is a standard published by the International Organization for Standardization (ISO). Its full title is "Dentistry — Dental rubber dam instruments — Part 2: Clamp forceps". This standard covers: ISO 16635-2:2014 specifies requirements and test methods for clamp forceps intended for the application of dental rubber dam clamps to teeth.
ISO 16635-2:2014 specifies requirements and test methods for clamp forceps intended for the application of dental rubber dam clamps to teeth.
ISO 16635-2:2014 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.
ISO 16635-2:2014 has the following relationships with other standards: It is inter standard links to EN ISO 16635-2:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 16635-2:2014 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 16635-2
First edition
2014-09-15
Dentistry — Dental rubber dam
instruments —
Part 2:
Clamp forceps
Médecine bucco-dentaire — Instruments de digue dentaire en
caoutchouc —
Partie 2: Pinces porte-crampons
Reference number
©
ISO 2014
© ISO 2014
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Total length. 2
4.3 Locking part . 2
4.4 Distance between the forceps handles in the closed, passive state . 2
4.5 Retaining pins . 2
4.6 Spring and ability to return to the original state . 3
4.7 Materials . 3
4.8 Surface finish . 3
4.9 Corrosion resistance and resistance to reprocessing . 3
5 Test methods . 3
5.1 Visual examination . 3
5.2 Dimensions . 3
5.3 Reprocessing . 3
6 Marking . 4
Foreword
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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
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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
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For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
ISO 16635 consists of the following parts, under the general t
...
NORME ISO
INTERNATIONALE 16635-2
Première édition
2014-09-15
Médecine bucco-dentaire —
Instruments de digue dentaire en
caoutchouc —
Partie 2:
Pinces porte-crampons
Dentistry — Dental rubber dam instruments —
Part 2: Clamp forceps
Numéro de référence
©
ISO 2014
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2014
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie, l’affichage sur
l’internet ou sur un Intranet, sans autorisation écrite préalable. Les demandes d’autorisation peuvent être adressées à l’ISO à
l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Publié en Suisse
ii © ISO 2014 – Tous droits réservés
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Exigences . 2
4.1 Généralités . 2
4.2 Longueur totale . 2
4.3 Verrou . 2
4.4 Écartement des poignées de la pince à l’état passif, fermé . 2
4.5 Goupilles de retenue . 2
4.6 Ressort et aptitude au retour à l’état initial . 3
4.7 Matériaux . 3
4.8 État de surface . 3
4.9 Résistance à la corrosion et résistance au retraitement . 3
5 Méthodes d’essai . 4
5.1 Examen visuel . 4
5.2 Dimensions . 4
5.3 Retraitement . 4
6 Marquage . 4
Avant-propos
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nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
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critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
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du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de brevets reçues par
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Pour une explication de la signification des termes et expressions spécifiques de l’ISO liés à l’évaluation de
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les obstacles techniques au commerce (OTC), voir le lien suivant: Avant-propos — Informations
supplémentaires.
Le Comité chargé de l’élaboration du présent document est l’ISO/TC 106, Médecine bucco-dentaire, sous-
comité 4, Instruments dentaires.
L’ISO 16635 comprend les parties suivantes, présentées sous le titre général Médecine bucco-dentaire —
Instruments de la digue dentaire en caoutchouc:
— Partie 1: Pince emporte-pièce
— Partie 2: Pince porte-crampon
iv © ISO 2014 – Tous droits réservés
Introduction
Pour soutenir l’utilisation cr
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