SIST EN ISO 16635-2:2014
(Main)Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014)
Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014)
ISO 16635-2:2014 specifies requirements and test methods for clamp forceps intended for the application of dental rubber dam clamps to teeth.
Zahnheilkunde - Kofferdaminstrumente - Teil 2: Klammerzangen (ISO 16635-2:2014)
Dieser Teil von ISO 16635 legt Anforderungen an und Prüfverfahren für Klammerzangen fest, die zur Applikation von Kofferdamklammern an Zähnen vorgesehen sind.
Médecine bucco-dentaire - Instruments de digue dentaire en caoutchouc - Partie 2: Pinces porte-crampons (ISO 16635-2:2014)
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.
Zobozdravstvo - Dentalni instrumenti za tesnitev zob - 2. del: Oprijemalne klešče (ISO 16635-2:2014)
Ta del standarda določa zahteve in preskusne metode za oprijemalne klešče, ki so namenjene za namestitev dentalnih sponk na zobe.
General Information
- Status
- Published
- Public Enquiry End Date
- 09-May-2013
- Publication Date
- 13-Nov-2014
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 02-Oct-2014
- Due Date
- 07-Dec-2014
- Completion Date
- 14-Nov-2014
Overview
SIST EN ISO 16635-2:2014 is an international standard specifying the requirements and test methods for clamp forceps used in dental rubber dam applications. Developed by ISO/TC 106 “Dentistry” and endorsed as a European Standard by CEN, this document standardizes the design, materials, dimensions, and performance criteria for clamp forceps. These forceps are essential instruments for applying dental rubber dam clamps to teeth, isolating treatment areas in restorative dental procedures.
The comprehensive framework provided by SIST EN ISO 16635-2:2014 ensures the safety, reliability, and effectiveness of clamp forceps while supporting dental professionals in clinical practice. These standardized specifications enable consistency in manufacturing and function across international markets.
Key Topics
Scope and Purpose
Specifies clamp forceps intended to securely hold dental rubber dam clamps without contacting the tooth surface, facilitating efficient placement.Design Requirements
- Total length capped at 175 mm to ensure ergonomic handling.
- Locking mechanism that securely holds and releases clamps during application.
- Angled or stepped working ends with retaining pins featuring depth-control stops for safe orientation of clamps in three spatial directions.
- Distance between handles in a passive state limited to 95 mm for user comfort.
Materials and Hardness
Clamp forceps must be made from martensitic or austenitic corrosion-resistant stainless steel with hardness levels between 42 and 55 HRC or equivalent Vickers hardness. This ensures durability and resistance to wear.Surface Finish and Corrosion Resistance
Manufacturers may opt for brightened or matted surfaces that must be free from pores, cracks, and residues. Instruments are required to endure at least 100 reprocessing cycles per ISO 17664 without deterioration or corrosion.Test Methods
Includes visual inspection, dimensional accuracy checks with high precision measuring tools (≤0.1 mm tolerance), and reprocessing cycle tests to verify compliance.Marking Requirements
Forceps must be clearly marked with manufacturer’s name or brand, model number, and batch or lot number for traceability.
Applications
Clamp forceps compliant with SIST EN ISO 16635-2:2014 are critical in dental restorative treatments where a rubber dam is used. The rubber dam isolates teeth to provide a dry working field, improve visibility, and prevent contamination. Proper use of clamp forceps enables precise, safe, and efficient placement of clamps on teeth, enhancing procedural success and patient comfort. These instruments are widely utilized by dentists, endodontists, and dental hygienists.
Benefits of standardized clamp forceps include:
- Enhanced clinical safety and performance consistency.
- Extended instrument lifespan due to corrosion and wear resistance.
- Ease of sterilization and reprocessing, critical for infection control.
- Compatibility with a wide range of dental rubber dam clamps.
Related Standards
- ISO 16635-1: Dentistry – Dental rubber dam instruments – Part 1: Hole punch. Defines requirements for instruments used to punch holes in rubber dam sheets.
- ISO 17664: Sterilization of medical devices – Information for manufacturers regarding cleaning, disinfection, and sterilization processes. Crucial for ensuring safe reprocessing of clamp forceps.
- ISO 1942: Dentistry – Vocabulary, providing standardized terminology essential for clarity in dental instrument specifications.
- ISO 6507-1 & ISO 6508-1: Metallic Materials Hardness Testing methods (Vickers and Rockwell), used to assess material properties for clamp forceps manufacturing.
- ISO 15510:2010: Stainless steels – Chemical composition standards ensuring appropriate material selection for corrosion resistance in dental instruments.
By adhering to SIST EN ISO 16635-2:2014, manufacturers and dental practitioners ensure safe, effective, and durable clamp forceps that meet international quality benchmarks essential for modern dental care.
Frequently Asked Questions
SIST EN ISO 16635-2:2014 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014)". 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.
SIST EN ISO 16635-2:2014 is classified under the following ICS (International Classification for Standards) categories: 11.060.25 - Dental instruments. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 16635-2:2014 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 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)
SLOVENSKI STANDARD
01-december-2014
=RER]GUDYVWYR'HQWDOQLLQVWUXPHQWL]DWHVQLWHY]REGHO 2SULMHPDOQHNOHãþH
,62
Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014)
Zahnheilkunde - Kofferdaminstrumente - Teil 2: Klammerzangen (ISO 16635-2:2014)
Médecine bucco-dentaire - Instruments de digue dentaire en caoutchouc - Partie 2:
Pinces porte-crampons (ISO 16635-2:2014)
Ta slovenski standard je istoveten z: EN ISO 16635-2:2014
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 16635-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2014
ICS 11.060.20
English Version
Dentistry - Dental rubber dam instruments - Part 2: Clamp
forceps(ISO 16635-2:2014)
Médecine bucco-dentaire - Instruments de digue dentaire Zahnheilkunde - Kofferdaminstrumente - Teil 2:
en caoutchouc - Partie 2: Pinces porte-crampons (ISO Klammerzangen (ISO 16635-2:2014)
16635-2:2014)
This European Standard was approved by CEN on 28 June 2014.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16635-2:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 16635-2:2014) 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 March 2015, and conflicting national standards shall be withdrawn at
the latest by March 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16635-2:2014 has been approved by CEN as EN ISO 16635-2:2014 without any modification.
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 16635-2:2014(E)
©
ISO 2014
ISO 16635-2:2014(E)
© 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
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ii © ISO 2014 – All rights reserved
ISO 16635-2:2014(E)
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 .
...
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