EN ISO 21530:2004
(Main)Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (ISO 21530:2004)
Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (ISO 21530:2004)
ISO 21530:2004 specifies test methods for determining the resistance to chemical disinfectants of all materials used for external surfaces of dental equipment intended for such disinfection.
Three test methods are specified: an immersion test, a spray test and a contact test. The choice of test method to be used is left to the discretion of the party conducting the testing.
ISO 21530:2004 does not address the bactericidal, virucidal and fungicidal effectivity of the disinfectants.
ISO 21530:2004 does not provide for testing the possible detrimental effects of applied stress on the resistance of test materials to the test reagents.
Zahnheilkunde - Materialien für Oberflächen von zahnärztlichen Ausrüstungen - Bestimmung der Beständigkeit gegen chemische Desinfektionsmittel (ISO 21530:2004)
Diese Internationale Norm legt Prüfverfahren zum Bestimmen der Beständigkeit gegen chemische Desinfektionsmittel von Materialien fest, die für Außenflächen von zahnärztlichen Ausrüstungen verwendet werden. Diese Außenflächen sind für die Desinfektion durch chemische Desinfektionsmittel vorgesehen.
Drei Prüfverfahren werden festgelegt: eine Eintauchprüfung, eine Sprühprüfung und eine Kontaktprüfung. Das anzuwendende Prüfverfahren liegt im Ermessen desjenigen, der die Prüfung durchführt.
Diese Internationale Norm beschreibt nicht die bakterizide, viruzide oder fungizide Wirksamkeit der Desinfektionsmittel.
Diese Internationale Norm beschreibt nicht Prüfungen auf mögliche schädliche Auswirkungen auf die Reagenzien unter Prüfbelastungen.
Art dentaire - Matériaux utilisés pour les surfaces du matériel dentaire - Détermination de la résistance aux désinfectants chimiques (ISO 21530:2004)
L'ISO 21530:2004 spécifie des méthodes d'essai permettant de déterminer la résistance aux désinfectants chimiques de tous les matériaux utilisés sur des surfaces externes du matériel dentaire susceptibles de subir une telle procédure de désinfection.
Trois méthodes sont spécifiées: un essai par immersion, un essai par vaporisation et un essai par contact. Le choix de la méthode d'essai à utiliser est laissé à la discrétion de la partie qui effectue l'essai.
L'ISO 21530:2004 ne traite pas de l'efficacité bactéricide, virucide et fongicide des désinfectants.
L'ISO 21530:2004 ne contient aucune disposition relative au contrôle des éventuels effets préjudiciables sur la résistance des matériaux d'essai aux réactifs d'essai, induits par la contrainte appliquée.
Zobozdravstvo – Materiali za uporabo na površinah zobozdravstvene opreme – Določanje odpornosti proti kemičnim dezinfekcijskim sredstvom (ISO 21530:2004)
General Information
- Status
- Published
- Publication Date
- 14-Jun-2004
- Withdrawal Date
- 30-Dec-2004
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 03-Mar-2009
- Completion Date
- 03-Mar-2009
Relations
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Referred By
EN 15016-2:2023+A1:2025 - Railway applications - Technical documents - Part 2: Parts lists - Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Referred By
EN ISO 19115-1:2014 - Geographic information - Metadata - Part 1: Fundamentals (ISO 19115-1:2014) - Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
Overview
EN ISO 21530:2004 - Dentistry: Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants specifies laboratory test methods to evaluate how materials used on the external surfaces of dental equipment withstand exposure to chemical disinfectants. The standard defines three test approaches-immersion, spray and contact tests-and leaves the selection of the most appropriate method to the testing party. EN ISO 21530:2004 focuses exclusively on material resistance and does not evaluate the bactericidal, virucidal or fungicidal efficacy of disinfectants, nor does it address effects of applied mechanical stress on material resistance.
Key Topics and Requirements
- Scope: Tests apply to all materials used for external surfaces of dental equipment intended to be disinfected.
- Test methods: Three distinct procedures are provided:
- Immersion test - material specimens immersed in disinfectant.
- Spray test - surface exposure by sprayed disinfectant.
- Contact test - localized application/contact exposure.
- Choice of method: Selection of immersion, spray or contact testing is at the discretion of the test operator based on intended real‑world use.
- Outcome focus: Assessment of chemical resistance-appearance changes, surface degradation, discoloration or loss of functional surface properties after exposure.
- Limitations: Standard explicitly excludes evaluation of disinfectant efficacy (microbial kill rates) and does not account for how mechanical stress may change resistance.
Applications
- Validate durability of surface materials on dental chairs, lights, instrument trays, cabinetry and control panels exposed to routine chemical disinfection.
- Support product development by identifying materials compatible with common chemical disinfectants used in dental clinics.
- Inform maintenance and cleaning recommendations provided in equipment user manuals.
- Provide evidence for regulatory submissions or conformity assessments where demonstration of material resistance to disinfectants is required.
Who Uses This Standard
- Dental equipment manufacturers assessing material choices for exterior surfaces.
- Materials laboratories and test houses performing standardized chemical resistance testing.
- Regulatory bodies and conformity assessors reviewing device labeling and cleaning instructions.
- Infection control officers and dental clinic facility managers seeking guidance about material compatibility with disinfectants.
Related Standards
- Standards covering disinfectant efficacy (biocidal testing), sterilization and cleaning of medical devices, and general dental materials testing are complementary when developing a comprehensive infection‑control and materials‑selection strategy.
Keywords: EN ISO 21530:2004, dental equipment surfaces, chemical disinfectants, disinfection resistance testing, immersion test, spray test, contact test.
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Frequently Asked Questions
EN ISO 21530:2004 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Materials used for dental equipment surfaces - Determination of resistance to chemical disinfectants (ISO 21530:2004)". This standard covers: ISO 21530:2004 specifies test methods for determining the resistance to chemical disinfectants of all materials used for external surfaces of dental equipment intended for such disinfection. Three test methods are specified: an immersion test, a spray test and a contact test. The choice of test method to be used is left to the discretion of the party conducting the testing. ISO 21530:2004 does not address the bactericidal, virucidal and fungicidal effectivity of the disinfectants. ISO 21530:2004 does not provide for testing the possible detrimental effects of applied stress on the resistance of test materials to the test reagents.
ISO 21530:2004 specifies test methods for determining the resistance to chemical disinfectants of all materials used for external surfaces of dental equipment intended for such disinfection. Three test methods are specified: an immersion test, a spray test and a contact test. The choice of test method to be used is left to the discretion of the party conducting the testing. ISO 21530:2004 does not address the bactericidal, virucidal and fungicidal effectivity of the disinfectants. ISO 21530:2004 does not provide for testing the possible detrimental effects of applied stress on the resistance of test materials to the test reagents.
EN ISO 21530:2004 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 21530:2004 has the following relationships with other standards: It is inter standard links to EN 396:1993, CEN ISO/TS 15877-7:2009, EN 13629:2002, EN 915:1996, CEN ISO/TS 17425:2016, CEN ISO/TS 18234-7:2013, EN ISO 3166-1:2014, EN 15969-2:2011, EN 15016-4:2006, EN ISO 12855:2012, EN 15016-2:2023+A1:2025, EN 15016-4:2023, EN ISO 19115-1:2014, EN ISO 3166-1:2006, EN ISO 7200:2004. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 21530:2004 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.
EN ISO 21530:2004 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-januar-2005
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Dentistry - Materials used for dental equipment surfaces - Determination of resistance to
chemical disinfectants (ISO 21530:2004)
Zahnheilkunde - Materialien für Oberflächen von zahnärztlichen Ausrüstungen -
Bestimmung der Beständigkeit gegen chemische Desinfektionsmittel (ISO 21530:2004)
Art dentaire - Matériaux utilisés pour les surfaces du matériel dentaire - Détermination de
la résistance aux désinfectants chimiques (ISO 21530:2004)
Ta slovenski standard je istoveten z: EN ISO 21530:2004
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
...
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