SIST EN ISO 13397-1:2000

Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)

Specifies the general material and performance requirements for periodontal curettes, dental scalers and excavators.

Parodontalküretten, zahnärtzliche Schaber und Exkavatoren - Teil 1: Allgemeine Anforderungen (ISO 13397-1:1995)

Dieser Teil der ISO 13 397 beschreibt die allgemeinen Anforderungen (Werkstoff und Leistung) für Parodontalküretten, zahnärztliche Schaber und Exkavatoren.

Curettes parodontales, instruments dentaires pour détartrage et excavateurs dentaires - Partie 1: Prescriptions générales (ISO 13397-1:1995)

La présente partie de l'ISO 13397 fixe les prescriptions générales, pour le matériel et ses performances, relatives aux curettes parodontales, instruments dentaires pour détartrage et excavateurs dentaires.

Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)

General Information

• Status: Published
• Publication Date: 31-Dec-1999
• ICS: 11.060.20 - Dental equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jan-2000
• Due Date: 01-Jan-2000
• Completion Date: 01-Jan-2000
• Ref Project: EN ISO 13397-1:1995 - Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)

Relations

• Referred By: SIST EN 1639:2010 - Dentistry - Medical devices for dentistry - Instruments
• Effective Date: 28-Jan-2026

Overview

SIST EN ISO 13397-1:2000 outlines the general requirements for periodontal curettes, dental scalers, and dental excavators. Published by the Slovenski inštitut za standardizacijo (SIST) and aligned with ISO 13397-1:1995, this dental instruments standard ensures uniform material and performance specifications critical for both manufacturers and dental professionals. These requirements promote safety, durability, and consistency across key dental hand instruments used in diagnostic and treatment procedures.

Key Requirements

Material and Performance Standards

• Specifies acceptable materials for instrument manufacture, with particular preference for martensitic stainless steel compliant with ISO 7153-1 or other equivalent materials.
• Mandates the use of robust and corrosion-resistant materials, ensuring instrument longevity and patient safety.
• Defines two Vickers hardness classes for working ends, ensuring suitable durability:
  • Class 1: 600 HV1 - 700 HV1
  • Class 2: 550 HV1 - 620 HV1

Surface Finish and Hygiene

• Requires all instrument surfaces to be free of pores, crevices, grinding marks, scales, acids, greases, and residues after tooling.
• Satin and mirror finishes must be smooth and uniform for optimal glare reduction and visual inspection.

Thermal and Corrosion Resistance

• Instruments must maintain integrity and hardness after exposure to autoclaving and high temperatures.
• Strict criteria ensure there are no signs of visible corrosion post-sterilization or cleaning procedures.

Structural Integrity

• Demands robust union of the working end and handle, capable of withstanding standard tensile and torque forces during clinical use.
• Design and dimensions must meet detailed criteria for clinical effectiveness and ergonomic safety.

Testing and Measurement

• Stipulates use of standardized test methods for checking mechanical strength, hardness, and resistance to environmental factors.
• Dimensional checks employ optical measurement techniques for precision.

Practical Applications

Dental Clinical Use

• Provides guidelines for manufacturers to ensure production of safe, effective periodontal curettes, dental scalers, and excavators.
• Supports dental professionals by promoting instruments that are durable, easy to clean, and reliable during procedures such as scaling, root planing, and caries excavation.

Regulatory Compliance

• Enables dental device manufacturers to meet European and international requirements, facilitating market access and product acceptance.
• Serves as a benchmark in quality assurance programs and procurement specifications for dental healthcare organizations and clinics.

Sterilization & Maintenance

• Ensures instruments can undergo repeated sterilization cycles (autoclaving or boiling) without degradation, supporting infection control protocols.

Related Standards

• ISO 1942-3: Dental vocabulary - Part 3: Dental instruments
• ISO 6507-2: Metallic materials - Hardness test - Vickers test
• ISO 7153-1: Surgical instruments - Metallic materials - Part 1: Stainless steel
• ISO 13402: Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion, and thermal exposure

These related standards provide further details on terminology, materials testing, and instrument validation, ensuring that manufacturers and users adhere to the highest levels of dental instrument quality and performance.

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By following the general requirements outlined in SIST EN ISO 13397-1:2000, dental professionals, device manufacturers, and healthcare organizations can ensure the safe, effective, and long-lasting performance of vital dental instruments, meeting global standards for quality and patient care.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)Parodontalküretten, zahnärtzliche Schaber und Exkavatoren - Teil 1: Allgemeine Anforderungen (ISO 13397-1:1995)Curettes parodontales, instruments dentaires pour détartrage et excavateurs dentaires - Partie 1: Prescriptions générales (ISO 13397-1:1995)Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)11.060.20Dental equipmentICS:Ta slovenski standard je istoveten z:EN ISO 13397-1:1995SIST EN ISO 13397-1:2000en01-januar-2000SIST EN ISO 13397-1:2000SLOVENSKI
STANDARD
INTERNATIONAL STANDARD Is0 13397-I First edition 1995-l 2-15 Periodontal curettes, dental scalers and excavators - Part 1: General requirements Curettes parodon tales, instruments den taires pour d6 tartrage et excavateurs dentaires - Partie 7 : Prescriptions g&Wales Reference number IS0 13397-l :I 995(E) SIST EN ISO 13397-1:2000

IS0 133974:1995(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 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. IS0 collaborates closely with the International Electrotechnical Commission (I EC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 13397-l was prepared by Technical Committee lSO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments. IS0 13397 consists of the following parts, under the general title Periodontal cure ttes, dental scalers and excava tars: - Part 7: General requirements - Part 2: Dental curettes - Gr-type - Part 3: Dental scalers - H-type - Part 4: Dental excavators It is anticipated of future parts. that additional types of instruments will form the subject Annex A of this part of IS0 13397 is for information only. 0 IS0 1995 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced including photocopying and or utilized microfilm, in any form or by any means, electronic without permission in writing from the or mechanical, publisher. International Organization for Standardization Case Postale 56 l CH-121 1 Geneve 20 l Switzerland Printed in Switzerland ii SIST EN ISO 13397-1:2000

INTERNATIONAL STANDARD Q IS0 IS0 13397=1:1995(E) Periodontal curettes, dental scalers and excavators - Part 1: General -requirements 1 Scope This part of IS0 13397 specifies the general material and performance requirements for periodontal curettes, dental scalers and excavators. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 13397. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 13397 are encouraged to investi- gate the possibility of applying the most recent edi- tions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 1942-3: 1989, Dental vocabulary - Part 3: Dental instruments. IS0 6507-2:1983, Metallic materials - Hardness test - Vickers test - Part 2: HV 0,2 to less than HV5. IS0 7153-I :I 991, Surgical instruments - Metallic materials - Part 1: Stainless steel. IS0 13402:1995, Surgical and dental hand instru- ments - Determination of resistance against autoclaving, corrosion and thermal exposure. 3 Definitions For the purposes of this part of IS0 13397, the defi- nitions given in IS0 1942-3 apply. 4 Classification Periodontal curettes, dental scalers and excavators specified in all parts of IS0 13397 are classified ac- cording to the Vickers hardness of the working end: class 1: 600 HVI - 700 HVI class 2: 550 HVI - 620 HVI 5 Material 5.1 Material of working end The working end shall be made of martensitic stain- less steel complying with IS0 7153-1 or other ma- terials providing the instrument made therefrom meets the requirements of clause 6. 5.2 Material of handle The material of the handle, selected at the discretion of the manufacturer, shall meet the requirements of c!ause 6. 6 Requirements 6.1 Surface finish 6.1.1 All surfaces All surfaces shall be visibly free from pores, crevices, grinding marks, residual scales, acid, grease and re- sidual grinding and polishing materials, when in- spected using normal vision. SIST EN ISO 13397-1:2000

IS0 13397=1:1995(E) 0 IS0 6.1.2 Satin finish Satin finish shall be both uniform and smooth, and it shall reduce glare. 6.1.3 Mirror finish Mirror finish shall be ground to remove all surface imperfections and polished to remove grind marks, resulting
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