SIST 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
SIST EN ISO 21850-1:2020 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST EN ISO 21850-1:2020 is classified under the following ICS (International Classification for Standards) categories: 11.060.25 - Dental instruments; 77.140.20 - Stainless steels. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST 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 SIST 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 SIST 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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CH-1214 Vernier, Geneva
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
...
The SIST EN ISO 21850-1:2020 standard provides a comprehensive framework for the selection and specification of stainless steel materials used in the manufacturing of dental instruments. The scope of this standard is clearly defined, focusing on the materials applicable for both single-use and reusable dental instruments. It recognizes the critical role that stainless steel plays in ensuring the safety and efficacy of dental tools, catering to instruments that may or may not be connected to a power-driven system. One of the significant strengths of this standard is its meticulous identification of stainless steels that are suitable for dental instrumentation. By curating a specific selection of stainless steel grades, it allows manufacturers to make informed choices that can enhance the longevity and performance of their products. This is particularly relevant in the context of dental instruments where material integrity is paramount to patient safety and procedural success. Additionally, the standard crystallizes the scope of application by explicitly stating its limitations, which reinforces its relevance. It clarifies that it does not cover devices intended for long-term use in a patient’s mouth, such as crowns, bridges, and implants, ensuring that users understand the precise boundaries of the standard. This focus on appropriate applications helps prevent misunderstandings and promotes standard compliance. In summary, SIST EN ISO 21850-1:2020 serves as an essential reference document that supports manufacturers in the dental industry by offering guidelines on the selection of stainless steels for dental instruments, enhancing product quality, safety, and efficacy. Its clear scope, selection criteria, and exclusion of unrelated applications demonstrate its robustness and relevance in today's dental manufacturing landscape.
SIST EN ISO 21850-1:2020は、歯科用器具に使用されるステンレス鋼の標準化文書であり、歯科用器具の製造に用いられるステンレス鋼の特性や要求事項を詳細に定義しています。この標準の範囲は、単一使用および再利用可能な歯科用器具に適用され、パワードライブシステムに接続されているかどうかを問わず、全ての器具またはその一部の製造に使用されるステンレス鋼に関わります。 本標準の強みは、最新のステンレス鋼の選定が含まれ、歯科用器具の製造に適した材料を明確にしている点です。また、患者の口内に長期間使用されるデバイスや、ステンレス鋼以外で作られた器具には適用されないことが明示されており、使用の範囲を明確に制限しています。これにより、実際の製造プロセスにおいて必要とされる材料の品質と一貫性を確保することが可能になります。 SIST EN ISO 21850-1:2020は、歯科業界において非常に関連性が高く、信頼性のある歯科用器具の製造に貢献する重要な役割を果たしています。この標準に準拠することで、製造業者は高い品質基準を維持し、医療現場での安全性と効果を確保することができます。
Die Norm SIST EN ISO 21850-1:2020 befasst sich mit einem äußerst wichtigen Bereich der Zahnmedizin, namentlich den Materialien für zahnmedizinische Instrumente aus Edelstahl. Der Anwendungsbereich dieser Norm ist klar definiert und umfasst Edelstahl, der zur Herstellung von zahnmedizinischen Instrumenten eingesetzt wird, seien es vollständige Instrumente oder Teile davon. Ein zentraler Vorteil dieser Norm ist ihre umfassende Anwendbarkeit für sowohl Einweg- als auch wiederverwendbare zahnmedizinische Instrumente. Darüber hinaus berücksichtigt die Norm Geräte, die nicht mit einem elektrisch betriebenen System verbunden sind, was ihre Relevanz im modernen zahnmedizinischen Umfeld erhöht. Es ist von erheblichem Nutzen, dass die Norm auch eine aktuelle Auswahl an Edelstahltypen bietet, die für die Herstellung zahnmedizinischer Instrumente geeignet sind, wodurch Fachleuten die Entscheidungsfindung erleichtert wird und die Qualität der Instrumente sichergestellt werden kann. Ein weiterer Stärke der Norm ist die klare Abgrenzung des Anwendungsbereichs. Geräte und Instrumente, die langfristig im Mund des Patienten verbleiben, wie Kronen, Brücken und Implantate, sind ausdrücklich ausgeschlossen. Dies sorgt dafür, dass die Norm sich gezielt auf die spezifischen Anforderungen und Eigenschaften von Instrumenten konzentriert, die in der direkten zahnmedizinischen Behandlung eingesetzt werden. Zusammenfassend lässt sich sagen, dass die SIST EN ISO 21850-1:2020 eine essentielle Grundlage für die Qualitätssicherung in der zahnärztlichen Praxis bietet. Die Fokussierung auf Edelstahl und die Klarheit des Anwendungsbereichs machen diese Norm zu einem wertvollen Referenzdokument für alle, die in der Herstellung und Anwendung von zahnmedizinischen Instrumenten tätig sind.
주문서 SIST EN ISO 21850-1:2020은 치과 기구 제작에 사용되는 스테인리스 스틸 소재에 대한 표준을 규정하고 있습니다. 이 문서는 전체 기구 또는 기구의 일부를 제조하기 위해 사용되는 스테인리스 스틸의 명세를 제공합니다. 단일 사용 및 재사용 가능한 치과 기구 모두에 적용될 수 있으며, 전동 시스템과 연결 여부에 관계없이 해당됩니다. 이 표준의 강점은 현대 치과 기구 제작에 적합한 스테인리스 스틸의 현재 선택을 제공한다는 점입니다. 이는 치과의료 분야에서 스테인리스 스틸의 품질과 신뢰성을 보장하여 환자의 안전과 기구의 내구성을 높이는 데 기여합니다. 특히, 이 표준은 치과 기구 제작을 위해 사용되는 스테인리스 스틸의 물리적 및 화학적 특성을 상세하게 정의함으로써 제조업체가 일관된 품질의 제품을 생산할 수 있도록 지원합니다. 또한, SIST EN ISO 21850-1:2020은 장기적으로 환자의 구강 내에 사용되는 장치(예: 크라운, 브리지, 임플란트)나 스테인리스 스틸이 아닌 소재로 제작된 장치 및 기구에는 적용되지 않음을 명확히 하여, 특정 규제 및 기준을 설정합니다. 이러한 명확한 범위 설정은 제조업체가 관련 규정을 준수하고, 치과 기구의 안전성과 효과성을 높이는 데 도움을 줍니다. 결론적으로, SIST EN ISO 21850-1:2020은 치과 기구 제조에 사용되는 스테인리스 스틸의 표준화된 명세를 제공함으로써, 치과 기구의 품질 관리를 위한 중요한 기준이 됩니다. 이는 치과 분야의 발전뿐만 아니라 환자의 보호와 의료 서비스의 향상에도 기여할 것입니다.
La norme SIST EN ISO 21850-1:2020 établit des spécifications essentielles concernant l'acier inoxydable utilisé pour la fabrication d'instruments dentaires. Son champ d'application est clairement défini, se concentrant sur les matériaux en acier inoxydable qui sont employés tant pour la fabrication d'instruments complets que de leurs différentes parties. Un des points forts de cette norme réside dans sa capacité à s'appliquer à une large gamme d'instruments dentaires, qu'ils soient à usage unique ou réutilisables. Cette inclusivité garantit que les fabricants et les professionnels de la santé dentaire disposent de directives précises pour le choix de matériaux adaptés, qu'il s'agisse d'instruments manuels ou de ceux connectés à un système entraîné par énergie. En précisant les types d'acier inoxydable les plus appropriés, la norme facilite le développement de produits qui respectent les exigences de sécurité et de fiabilité en milieu dentaire. Il est également pertinent de noter que cette norme ne couvre pas les dispositifs et instruments destinés à un usage à long terme dans la cavité buccale du patient, tels que les couronnes, les bridges ou les implants. Cela permet de concentrer les efforts sur des instruments temporaires ou d'usage courant, garantissant ainsi une approche ciblée sur des applications spécifiques. En résumé, la SIST EN ISO 21850-1:2020 se révèle non seulement pertinente pour les fabricants d'instruments dentaires mais également pour les professionnels de la santé qui recherchent des matériaux conformes aux standards les plus récents du secteur. Ce document offre une base solide pour assurer la qualité et la sécurité des instruments dentaires fabriqués en acier inoxydable.
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