SIST EN ISO 18556:2016
(Main)Dentistry - Intraoral spatulas (ISO 18556:2016)
Dentistry - Intraoral spatulas (ISO 18556:2016)
ISO 18556:2016 specifies requirements and their test methods for metallic and non-metallic intraoral spatulas used to introduce and model filling materials into a tooth cavity, including single use disposable items.
NOTE This includes instruments used for placement and contouring of non-metallic direct restorative materials.
It also specifies requirements for their marking and labelling.
Zahnheilkunde - Intraoralspatel (ISO 18556:2016)
Médecine bucco-dentaire - Spatules intraorale (ISO 18556:2016)
ISO 18556:2016 spécifie des exigences, et les méthodes d'essai correspondantes, relatives aux spatules à bouche métalliques et non métalliques, y compris les spatules à usage unique jetables, destinées à être utilisées pour mettre en place et modeler des produits d'obturation dans une cavité dentaire.
NOTE Ces instruments incluent ceux utilisés pour la mise en place et l'ajustage de produits de restauration directe non métalliques.
ISO 18556:2016 spécifie également des exigences relatives à leur marquage et étiquetage.
Zobozdravstvo - Intraoralne spatule (ISO 18556:2016)
Ta mednarodni standard se uporablja za intraoralne spatule (npr. kovinske Heidemann spatule) ter določa zahteve in preskusne metode za oblike in dimenzije ter informacije o označevanju.
General Information
- Status
- Published
- Publication Date
- 16-Jun-2016
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 06-May-2016
- Due Date
- 11-Jul-2016
- Completion Date
- 17-Jun-2016
Overview
SIST EN ISO 18556:2016 is an international standard developed by CEN and ISO specifying requirements and test methods for intraoral spatulas used in dentistry. These instruments, which can be metallic or non-metallic, are essential tools for introducing and shaping filling materials within tooth cavities. The standard covers both reusable and single-use disposable spatulas, emphasizing quality, safety, and performance. It also regulates the marking and labelling requirements to ensure traceability and compliance.
Key Topics
- Scope and Application
SIST EN ISO 18556:2016 applies to intraoral spatulas designed for placement, introduction, and modeling of dental filling materials including non-metallic direct restorative substances. - Classification
Two main types of spatulas are defined:- Type 1: Oval, cutting, rigid blades
- Type 2: Rectangular, flat, flexible blades
- Dimensions and Design
Standardized dimensions ensure compatibility and usability. For example:- Blade width between 1.4 mm to 3.2 mm
- Blade thickness minimum of 0.2 mm
- Handle and spatula blade lengths clearly specified for functional use and packaging compatibility
- Materials
Metallic spatulas must be made from specific corrosion-resistant stainless steels (e.g., X20Cr13, X46Cr13), while non-metallic spatulas use plastic or ceramic materials as appropriate. - Hardness and Durability
Blade hardness ranges from 42 to 60 HRC (Rockwell scale) or 410 to 700 HV (Vickers hardness), ensuring resistance to deformation during use. - Surface Quality
Surfaces must be smooth and free from defects or residues. Coatings may be applied to enhance lubricity and visibility during dental procedures. - Reprocessing Requirements
Metallic spatulas must withstand at least 100 sterilization cycles without corrosion or loss of function, following ISO 17664 protocols. Non-metallic spatulas intended for multiple uses must meet similar durability, except single-use disposables which have manufacturer-defined limits. - Marking and Labelling
Instruments must be clearly marked with the manufacturer's name or mark, model/reference number, and batch/lot number for identification and quality control.
Applications
Intraoral spatulas conforming to SIST EN ISO 18556:2016 are vital in a variety of dental procedures, particularly:
- Restorative Dentistry
Placement and contouring of filling materials such as composites and amalgams into tooth cavities. - Direct Restorative Material Handling
Ensuring precise modeling and shaping of plastics or ceramic restorative materials during cavity restoration. - Single-Use Procedures
When sterility and cross-contamination control are critical, disposable spatulas meeting this standard provide safe, disposable options. - Reusable Instrument Sterilization
Facilitating efficient cleaning, disinfection, and sterilization processes in dental practices while maintaining instrument integrity.
Related Standards
For comprehensive dental instrument quality and safety, SIST EN ISO 18556:2016 is complemented by the following standards:
- ISO 1942: Dentistry - Vocabulary
Defines dental terminology ensuring consistency across instruments and procedures. - ISO 6507-1 & ISO 6508-1: Metallic materials - Hardness Tests (Vickers and Rockwell)
Provide methods to measure hardness of spatula blades to verify compliance. - ISO 17664: Sterilization of Medical Devices
Outlines manufacturer requirements for processing instructions ensuring intraoral spatulas can be effectively resterilized without degradation. - ISO 7153-1: Surgical Instruments - Materials - Metals
Specifies suitable corrosion-resistant stainless steel materials for surgical and dental instruments.
By adhering to SIST EN ISO 18556:2016, dental instrument manufacturers and healthcare providers ensure that intraoral spatulas meet stringent quality standards for safety, durability, and functionality - essential for effective restorative dental care. This standard supports patient safety and clinical performance through clear requirements for materials, dimensions, hardness, and reprocessing resilience.
Frequently Asked Questions
SIST EN ISO 18556:2016 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Intraoral spatulas (ISO 18556:2016)". This standard covers: ISO 18556:2016 specifies requirements and their test methods for metallic and non-metallic intraoral spatulas used to introduce and model filling materials into a tooth cavity, including single use disposable items. NOTE This includes instruments used for placement and contouring of non-metallic direct restorative materials. It also specifies requirements for their marking and labelling.
ISO 18556:2016 specifies requirements and their test methods for metallic and non-metallic intraoral spatulas used to introduce and model filling materials into a tooth cavity, including single use disposable items. NOTE This includes instruments used for placement and contouring of non-metallic direct restorative materials. It also specifies requirements for their marking and labelling.
SIST EN ISO 18556:2016 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.
SIST EN ISO 18556:2016 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 18556:2016 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-julij-2016
Zobozdravstvo - Intraoralne spatule (ISO 18556:2016)
Dentistry - Intraoral spatulas (ISO 18556:2016)
Zahnheilkunde - Intraoralspatel (ISO 18556:2016)
Médecine bucco-dentaire - Spatules intraorale (ISO 18556:2016)
Ta slovenski standard je istoveten z: EN ISO 18556:2016
ICS:
11.060.20 =RERWHKQLþQDRSUHPD Dental equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 18556
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2016
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Intraoral spatulas (ISO 18556:2016)
Médecine bucco-dentaire - Spatules à bouche (ISO Zahnheilkunde - Intraoralspatel (ISO 18556:2016)
18556:2016)
This European Standard was approved by CEN on 18 March 2016.
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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18556:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18556:2016) 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 October 2016, and conflicting national standards shall
be withdrawn at the latest by October 2016.
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 18556:2016 has been approved by CEN as EN ISO 18556:2016 without any modification.
INTERNATIONAL ISO
STANDARD 18556
First edition
2016-04-01
Dentistry — Intraoral spatulas
Médecine bucco-dentaire — Spatules intraorales
Reference number
ISO 18556:2016(E)
©
ISO 2016
ISO 18556:2016(E)
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved
ISO 18556:2016(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 1
5 Requirements . 2
5.1 Dimensions . 2
5.2 Material . 2
5.3 Handle. 3
5.4 Spatula blade . 3
5.5 Combination of handle and blade . 3
5.6 Surface . 3
5.7 Resistance to reprocessing . 3
6 Test methods . 3
6.1 Visual examination . 3
6.2 Dimensions . 4
6.3 Test of resistance to reprocessing . 4
7 Marking .
...
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