EN ISO 21850-1:2020
(Main)Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)
Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)
This document specifies stainless steel commonly used in manufacturing dental instruments.
It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument.
It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system.
This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of stainless steel.
It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.
Zahnheilkunde - Werkstoffe für Dentalinstrumente - Teil 1: Nichtrostende Stähle (ISO 21850-1:2020)
Dieses Dokument legt nichtrostende Stähle fest, die üblicherweise für die Herstellung von Dentalinstrumenten verwendet werden.
Es gilt für Werkstoffe aus nichtrostenden Stählen, die zur Herstellung von entweder einem ganzen Instrument oder einem Teil eines Instrumentes verwendet werden.
Es gilt für einmal verwendbare und wiederverwendbare Dentalinstrumente, unabhängig davon, ob sie an ein motorbetriebenes System angeschlossen werden oder nicht.
Dieses Dokument gilt nicht für Produkte und Instrumente, die langzeitig im Mund des Patienten verwendet werden (z. B. Kronen, Brücken, Implantate) oder für Produkte und Instrumente, die nicht aus nichtrostendem Stahl bestehen.
Es enthält eine aktuelle Auswahl an nichtrostenden Stählen, die für die Herstellung von Dentalinstrumenten geeigent sind.
Médecine bucco-dentaire - Matériaux pour instruments dentaires - Partie 1: Partie 1: Acier inoxydables (ISO 21850-1:2020)
Le présent document spécifie les aciers inoxydables d'usage courant pour la fabrication d'instruments dentaires.
Il est applicable aux aciers inoxydables utilisés pour fabriquer tout ou partie de l'instrument.
Il est applicable aux instruments dentaires à usage unique et réutilisables, raccordés à un système motorisé ou non.
Le présent document n'est pas applicable aux dispositifs et instruments utilisés à long terme dans la bouche du patient (par exemple, couronnes, bridges, implants) ni aux dispositifs et instruments non constitués d'acier inoxydable.
Il contient une sélection actuelle des aciers inoxydables utilisables pour la fabrication d'instruments dentaires.
Zobozdravstvo - Materiali za dentalne instrumente - 1. del: Nerjavno jeklo (ISO 21850-1:2020)
General Information
Overview
EN ISO 21850-1:2020 - Dentistry: Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020) specifies the stainless steels commonly used to manufacture dental instruments. The standard covers material designation, chemical composition and selection guidance for stainless steels used for whole instruments or instrument parts. It applies to single‑use and reusable dental instruments, whether or not they are connected to power‑driven systems, but excludes long‑term intraoral devices (e.g., crowns, bridges, implants) and non‑stainless‑steel products.
This document aims to harmonize approval procedures across jurisdictions and reduce duplicated testing and certification costs for manufacturers and regulators.
Key topics and requirements
- Material designation and composition: Stainless steel grades and chemical composition are specified in accordance with ISO 15510. The standard includes tabulated compositions for major families: austenitic, martensitic, precipitation‑hardening and ferritic stainless steels.
- Selection guidance: Criteria and considerations for selecting appropriate stainless steel grades for specific instrument functions and manufacturing processes.
- Performance evaluation (pre‑clinical): Guidance on pre‑clinical testing to evaluate mechanical properties, corrosion resistance and overall performance before clinical use.
- Surface and polishability notes: Recommendations (for example, controlled sulfur levels) that can affect polishability and finishing of instruments.
- Informative annexes: Annex A provides equivalent stainless steel references; Annex B discusses hardness, corrosion resistance and mechanical strength.
- Terminology and references: Uses dental-specific terms from ISO 1942 and cross‑references biocompatibility and testing standards such as ISO 7405 and ISO 10993‑1.
Applications
- Ensures material consistency and safety for the production of dental forceps, probes, scalers, surgical instruments, handpieces components and other stainless‑steel parts used in dentistry.
- Supports manufacturers in material selection for both single‑use and reusable instruments, including those used with power‑driven systems.
- Helps quality and regulatory teams demonstrate compliance during product approval and market entry across CEN member countries.
Who should use this standard
- Dental instrument manufacturers and product designers
- Materials engineers and metallurgists working in medical device production
- Regulatory affairs and quality managers responsible for conformity assessment
- Test laboratories performing pre‑clinical and material evaluations
- Procurement specialists sourcing compliant stainless steel grades
Related standards (referenced)
- ISO 15510 - Stainless steels: chemical composition
- ISO 1942 - Dentistry vocabulary
- ISO 7405 - Biocompatibility evaluation in dentistry
- ISO 10993‑1 - Biological evaluation of medical devices
Keywords: EN ISO 21850-1:2020, ISO 21850-1, stainless steel, dental instruments, dentistry materials, austenitic stainless steel, martensitic stainless steel, material selection, dental instrument standards.
Frequently Asked Questions
EN ISO 21850-1:2020 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)". This standard covers: This document specifies stainless steel commonly used in manufacturing dental instruments. It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system. This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of stainless steel. It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.
This document specifies stainless steel commonly used in manufacturing dental instruments. It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system. This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of stainless steel. It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.
EN ISO 21850-1:2020 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 21850-1:2020 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.
You can purchase EN ISO 21850-1:2020 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.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2020
Zobozdravstvo - Materiali za dentalne instrumente - 1. del: Nerjavno jeklo (ISO
21850-1:2020)
Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)
Zahnheilkunde - Werkstoffe für Dentalinstrumente - Teil 1: Nichtrostende Stähle (ISO
21850-1:2020)
Médecine bucco-dentaire - Matériaux pour instruments dentaires - Partie 1: Partie 1:
Acier inoxydables (ISO 21850-1:2020)
Ta slovenski standard je istoveten z: EN ISO 21850-1:2020
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
77.140.20 Visokokakovostna jekla Stainless steels
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 21850-1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Materials for dental instruments - Part 1:
Stainless steel (ISO 21850-1:2020)
Médecine bucco-dentaire - Matériaux pour instruments Zahnheilkunde - Werkstoffe für Dentalinstrumente -
dentaires - Partie 1: Partie 1: Acier inoxydables (ISO Teil 1: Nichtrostende Stähle (ISO 21850-1:2020)
21850-1:2020)
This European Standard was approved by CEN on 26 April 2020.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21850-1:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 21850-1:2020) 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 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
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.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 21850-1:2020 has been approved by CEN as EN ISO 21850-1:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 21850-1
First edition
2020-04
Dentistry — Materials for dental
instruments —
Part 1:
Stainless steel
Médecine bucco-dentaire — Matériaux pour instruments dentaires —
Partie 1: Acier inoxydables
Reference number
ISO 21850-1:2020(E)
©
ISO 2020
ISO 21850-1:2020(E)
© ISO 2020
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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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 2020 – All rights reserved
ISO 21850-1:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 2
5 Selection of materials . 5
6 Performance evaluation — Pre-clinical evaluation .12
Annex A (informative) Equivalent stainless steels .13
Annex B (informative) Hardness, corrosion resistance, and mechanical strength .15
Bibliography .16
ISO 21850-1:2020(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, Dentistry, Subcommittee SC 4,
Dental instruments, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 21850 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
ISO 21850-1:2020(E)
Introduction
There is an increasing number of newly developed dental surgical techniques with an increasing
number of procedures such as dental implant placements. The market for the dental instrument is also
rapidly growing with demands for new and better instruments.
This document is intended to harmonize the approval procedures and to reduce the costs caused by
repeated approval and test procedures in different countries with regard to the stainless steel materials
used in dental instruments.
INTERNATIONAL STANDARD ISO 21850-1:2020(E)
Dentistry — Materials for dental instruments —
Part 1:
Stainless steel
1 Scope
This document specifies stainless steel commonly used in manufacturing dental instruments.
It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of
the instrument.
It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a
power-driven system.
This document is not applicable to devices and instruments used long-term in the mouth of the patient
(e.g. crown, bridges, implants) or to devices and instruments not made of stainless steel.
It contains a current selection of stainless steels suitable for use in the manufacture of dental
instruments.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 15510, Stainless steels — Chemical composition
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
dental instrument
tool specially designed for use in dentistry
3.2
stainless steel
steel whose most characterizing element is chromium of at least 10,5 % (mass fraction) Cr and maximum
1,2 % (mass fraction) C, and the primary importance of which is its resistance to corrosion
ISO 21850-1:2020(E)
3.2.1
austenitic stainless steel
stainless steel (3.2) typically composed of less than 0,2 % (mass fraction) C, at least 16 % (mass fraction)
Cr, typically about 18 % (mass fraction) Cr and over 8 % (mass fraction) Ni, which cannot be hardened
by heat treatment
3.2.2
martensitic stainless steel
stainless steel (3.2) with low to medium carbon, at least 0,08 % (mass fraction) C and between 11,5 %
(mass fraction) and 19 % (mass fraction) Cr, which can be hardened by quenching and tempering
3.2.3
precipitation-hardening stainless steel
stainless steel (3.2) with a high strength resulting from the precipitation of intermetallic compounds
(the formation of very fine intermetallic phases, carbides and laves phases in the structure) by a final
heat treatment
3.2.4
ferritic stainless steel
stainless steel (3.2) with low carbon with less than 0,1 % (mass fraction) C and between 10,5 % (mass
fraction) and 30 % (mass fraction) Cr, but which cannot be hardened by heat treatment
4 Materials
4.1 Material designation
The specification of the chemical composition and the material designation of the stainless steel
shall be in accordance with ISO 15510, if applicable. There can be minor differences in the chemical
compositions of stainless steel grades that are considered to equivalent to one another, where details
can be found in Annex A.
4.2 Composition of stainless steels
In Tables 1, 2, 3, and 4, composition of various stainless steels that are used for the manufacture of
instruments used in dentistry are listed.
Table 1 — Austenitic stainless steels (composition)
Number % (mass fraction), maximum values unless indicated otherwise
in this
a
C Si Mn P S N Cr Mo Ni Others
document
19,0 to 4,0 to 23,5 to Cu: 1,00
A1 0,02 0,75 2,00 0,035 0,015 0,15
22,0 5,0 26,0 to 2,00
0,12 to 17,5 to 8,0 to
A2 0,03 1,00 2,00 0,045 0,030 — —
0,22 19,5 11,0
17,0 to 2,5 to 12,5 to
A3 0,03 1,00 2,00 0,045 0,030 0,10 —
19,0 3,0 15,0
17,5 to 8,0 to
A4 0,07 1,00 2,00 0,045 0,030 0,10 — —
19,5 10,5
16,0 to 2,0 to 10,0 to
A5 0,08 1,00 2,00 0,045 0,030 0,10 —
18,0 3,0 13,0
minimum 17,0 to 8,0 to
A6 0,12 1,00 2,00 0,060 0,10 — Cu: 1 ,0
0,15 19,0 10,0
a
Particular ranges of sulfur mass fraction may provide improvement in certain properties. For polishability, a controlled
sulfur mass fraction of 0,015 % maximum is recommended.
b
Stainless steel is not listed in ISO 15510, but listed in EN 10088-1.
2 © ISO 2020 – All rights reserved
ISO 21850-1:2020(E)
Table 1 (continued)
Number % (mass fraction), maximum values unless indicated otherwise
in this
a
C Si Mn P S N Cr Mo Ni Others
document
0,05 to 16,0 to 6,0 to
A7 2,00 2,00 0,045 0,030 0,10 0,8 —
0,15 19,0 9,5
17,0 to 11,0 to
b
A8 0,06 1,00 2,00 0,045 0,015 0,11 — —
19,0 13,0
16,5 to 2,0 to 10,0 to Cu: 1,3
b
A9 0,03 1,00 2,00 0,045 0,1 to 0,2 —
18,5 2,5 13,0 to 1,8
17,5 to 8,0 to
A10 0,03 1,00 2,00 0,045 0,030 0,10 — —
19,5 10,5
16,5 to 2,0 to 10,0 to
A11 0,03 1,00 2,00 0,045 0,030 0,10 —
18,5 3,0 13,5
0,15 to 17,0 to 8,0 to
b
A12 0,10 1,00 2,00 0,045 0,10 — Cu: 1,0
0,35 19,0 10,0
a
Particular ranges of sulfur mass fraction may provide improvement in certain properties. For polishability, a controlled
sulfur mass fraction of 0,015 % maximum is recommended.
b
Stainless steel is not listed in ISO 15510, but listed in EN 10088-1.
Table 2 — Martensitic stainless steels (composition)
Number % (mass fraction), maximum values unless indicated otherwise
in this
a
C Si Mn P S N
...
EN ISO 21850-1:2020は、歯科器具の製造に使用されるステンレス鋼に関する標準化文書であり、その範囲が明確に定められています。この標準は、歯科器具全体またはその一部を製造するために一般的に使用されるステンレス鋼の仕様を提供し、単回使用および再使用可能な歯科器具に対して適用されます。また、電動システムに接続されているか否かにかかわらず、幅広い使用が可能です。 この文書の強みは、歯科器具製造に適したステンレス鋼の現在の選択肢を示している点であり、業界のニーズに応じた材質選定を容易にします。医療現場における安全性や衛生面を考慮する際、適切な材料の使用が重要であることを考えると、この標準は欠かせないものとなります。 一方で、長期間患者の口内で使用されるデバイスや、ステンレス鋼以外の材料で作られた器具には適用されないため、特定の用途に特化していることが、この文書の重要な特徴です。このように、EN ISO 21850-1:2020は、歯科業界におけるステンレス鋼の標準化を進め、品質や安全性の向上に寄与する非常に関連性の高い文書です。
La norme EN ISO 21850-1:2020 établit des critères essentiels concernant l'utilisation de l'acier inoxydable dans la fabrication d'instruments dentaires. Son champ d'application se concentre sur les matériaux en acier inoxydable souvent employés pour concevoir des instruments dentaires, qu'il s'agisse d'instruments entiers ou de parties d'instruments. Cette précision est essentielle, car elle garantit que les professionnels de la dentisterie disposent d'informations pertinentes sur les types de matériaux appropriés pour leurs instruments, qu’ils soient à usage unique ou réutilisables. Parmi les points forts de cette norme, on note sa capacité à couvrir une large gamme d'instruments dentaires, indépendamment de leur connexion à un système motorisé. Cela souligne l'importance croissante de l'acier inoxydable dans des applications diverses au sein des cabinets dentaires modernes. En fournissant une sélection actuelle d'aciers inoxydables adaptés à la fabrication d'instruments dentaires, le document assure aux praticiens qu'ils utilisent des matériaux conformes aux exigences de sécurité et de performance. La norme est particulièrement pertinente dans le contexte actuel où la qualité et la durabilité des matériaux dentaires sont primordiales pour garantir la satisfaction des patients et l'efficacité des soins. En précisant que la norme ne s'applique pas aux dispositifs utilisés à long terme dans la bouche des patients, comme les couronnes ou les implants, elle permet d'éviter des confusions et d'orienter clairement les utilisateurs vers des applications spécifiques de l'acier inoxydable. Ainsi, la norme EN ISO 21850-1:2020 représente un outil précieux pour les fabricants d'instruments dentaires et les praticiens. Sa pertinence réside dans sa capacité à standardiser l'utilisation de l'acier inoxydable dans un domaine où la sécurité et la fonctionnalité sont primordiales, renforçant ainsi la confiance et la qualité des soins dentaires.
The EN ISO 21850-1:2020 standard, titled "Dentistry - Materials for dental instruments - Part 1: Stainless steel," effectively outlines the specifications for stainless steel utilized in the manufacturing of dental instruments. This standard is particularly relevant for professionals in the dental industry as it details materials suitable for both single-use and reusable instruments, whether these instruments are part of a power-driven system or not. One of the key strengths of this standard is its comprehensive selection of stainless steels deemed appropriate for dental applications. By providing clear guidelines on the types of stainless steel that meet the criteria for safety and efficacy, EN ISO 21850-1:2020 offers manufacturers a reliable basis for material selection, ensuring consistency and quality in the production of dental instruments. Moreover, while the standard is broad in scope, it cleverly delineates its limitations, explicitly stating that it is not applicable to devices intended for long-term placement in the patient's mouth, such as crowns, bridges, or implants, nor does it cover instruments made from materials other than stainless steel. Such clarity prevents potential misunderstandings regarding the applicability of the standard, reinforcing its relevance in specialized contexts. Overall, EN ISO 21850-1:2020 stands as a critical resource for dental instrument manufacturers, ensuring that they adhere to established specifications for stainless steel materials, thus promoting patient safety and instrument reliability in dental practices.
SIST EN ISO 21850-1:2020 표준은 치과 기구 제작에 사용되는 스테인리스 스틸에 대한 규정을 명확히 정의하고 있습니다. 이 표준은 치과 기구의 전체 구성요소 또는 부분 제작에 사용되는 스테인리스 스틸 재료를 포괄합니다. 특히 일회용 및 재사용 가능한 치과 기구에 모두 적용 가능하다는 점에서 광범위한 적용 범위를 지닙니다. 이 표준의 가장 큰 강점 중 하나는 단순히 스테인리스 스틸에 대한 명세를 제공하는 데 그치지 않고, 다양한 종류의 스테인리스 스틸을 제시하여 치과 기구 제작에 필요한 적합한 재료를 효율적으로 선택할 수 있도록 돕는다는 것입니다. 또한, 전동 시스템과의 연결 여부와 관계없이 치과 기구에 적용될 수 있는 점은 사용자에게 큰 유연성을 제공합니다. 한편, 이 문서는 환자의 구강 내에 장기적으로 사용되는 장치와 기구(예: 크라운, 브리지, 임플란트) 및 비스테인리스 스틸로 제작된 장치와 기구에는 적용되지 않는다는 점에서 명확한 한계를 두고 있습니다. 이러한 명확한 스코프 설정은 표준의 적용에 있어 불필요한 혼란을 방지하고, 의료 기구의 안전성과 품질을 보장하는 데 기여합니다. 결론적으로, SIST EN ISO 21850-1:2020 표준은 치과 기구의 이상적인 스테인리스 스틸 재료를 정의하고, 효율적인 선택을 통해 치과 분야에서의 실용성을 높여주며, 관련 업계 및 의료 종사자들에게 중요한 참고 자료가 될 것입니다. 이러한 점에서 이 표준은 치과용 재료에 대한 신뢰를 높이고, 안전한 의료 환경을 조성하는 데 중대한 역할을 하고 있습니다.
Die Norm EN ISO 21850-1:2020 befasst sich mit dem wesentlichen Bereich der Materialien für zahnärztliche Instrumente, wobei der Schwerpunkt auf rostfreiem Stahl liegt. Dieser Standard definiert Anforderungen und Auswahlkriterien für die Verwendung von Edelstahl, der typischerweise in der Fertigung von zahnärztlichen Instrumenten eingesetzt wird. Ein wesentlicher Stärke dieser Norm ist ihre umfassende Anwendbarkeit auf verschiedene Arten von zahnärztlichen Instrumenten, einschließlich solcher, die als Einmal- oder Mehrwegprodukte konzipiert sind. Zudem berücksichtigt die Norm Instrumente, die mit powered systems verbunden sind, was ihre Relevanz in modernen zahnärztlichen Praxen unterstreicht. Dadurch wird sichergestellt, dass die verwendeten Materialien den hohen Anforderungen in Bezug auf Sicherheit und Funktionalität gerecht werden. Die Norm enthält eine aktuelle Auswahl an rostfreien Stählen, die als geeignet für die Herstellung zahnärztlicher Instrumente gelten. Dies bietet Herstellern und Fachleuten im Bereich der Zahnmedizin die nötigen Informationen, um qualitativ hochwertige Produkte zu gewährleisten, die sowohl den gesetzlichen Vorschriften als auch den Erwartungen der Anwender entsprechen. Es ist wichtig zu beachten, dass die Norm nicht für langfristige Geräte und Instrumente vorgesehen ist, die im Mund des Patienten verbleiben, wie beispielsweise Kronen, Brücken und Implantate. Auch Instrumente, die nicht aus rostfreiem Stahl bestehen, fallen nicht unter die Anwendung der Norm. Diese klare Abgrenzung trägt dazu bei, dass der Fokus auf den relevanten Teil des Marktes gelegt wird und damit die Spezifität und Wirksamkeit des Standards sichergestellt werden kann. Insgesamt ist die EN ISO 21850-1:2020 ein unverzichtbarer Leitfaden für Hersteller von zahnärztlichen Instrumenten, der sowohl die Qualitätsstandards als auch die Materialsicherheit im Blick hat und somit einen bedeutenden Beitrag zur Sicherheit und Effektivität in der Zahnmedizin leistet.
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