EN ISO 13397-1:1995
(Main)Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)
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
- 14-Dec-1995
- Withdrawal Date
- 29-Jun-1996
- Technical Committee
- CEN/TC 55 - Dentistry
- Drafting Committee
- CEN/TC 55 - Dentistry
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 26-Feb-2008
- Completion Date
- 26-Feb-2008
Relations
- Effective Date
- 28-Jan-2026
Overview
EN ISO 13397-1:1995 (CEN adoption) defines the general material and performance requirements for periodontal curettes, dental scalers and excavators. This Part 1 sets baseline criteria used by manufacturers, test laboratories and regulatory teams to verify that dental hand instruments meet accepted safety, durability and functional standards.
Key aspects covered include material selection, surface finish, hardness classification, resistance to sterilization and thermal exposure, and mechanical integrity of the union between working end and handle.
Key Topics
- Scope and purpose: Specifies general requirements applicable across instrument types covered by the ISO 13397 series.
- Material of working end: The working end shall be made of martensitic stainless steel complying with ISO 7153-1 or other materials that satisfy clause 6 performance requirements.
- Handle material: Selected at the manufacturer's discretion, provided it meets the same performance tests.
- Vickers hardness classification: Instruments are classified by Vickers hardness of the working end:
- Class 1: 600 HV - 700 HV
- Class 2: 550 HV - 620 HV The finished instrument is tested per ISO 6507-2 and the manufacturer must declare the hardness class for each instrument range.
- Surface finish: Requirements for visibly defect-free surfaces, with definitions for satin (uniform, reduces glare) and mirror finishes (highly reflective, ground and polished to remove imperfections).
- Corrosion and thermal resistance: Instruments must show no visible corrosion after specified autoclave/boiling and thermal tests (see ISO 13402 for test procedures). Vickers hardness must remain within the declared class after thermal exposure.
- Union strength: The working end‑to‑handle union must withstand a tensile load of 600 N (≥5 s) and a torque of 400 N·cm (≥5 s) without loosening.
- Measurement: Annex A describes a preferred optical projector (shadowgraph) method for dimensional and angular measurement of working ends.
Applications
This standard is essential for:
- Manufacturers designing and qualifying periodontal curettes, dental scalers and excavators.
- Quality and compliance teams verifying instrument durability, corrosion resistance and sterilization performance.
- Procurement and dental clinics requiring documented evidence of instrument performance and safe reprocessing.
By following EN ISO 13397-1:1995, stakeholders ensure instruments meet consistent mechanical and material criteria that support clinical safety and lifecycle performance.
Related Standards
- ISO 1942-3 - Dental vocabulary: definitions for dental instruments.
- ISO 6507-2 - Vickers hardness testing (HV 0.2 to < HV 5) used for hardness classification.
- ISO 7153-1 - Surgical instruments: martensitic stainless steel materials.
- ISO 13402 - Test methods for autoclaving, corrosion and thermal exposure.
- Other parts of ISO 13397 series (Parts 2–4) specify type‑specific design and dimensional requirements for curettes, scalers and excavators.
For manufacturers and laboratories, EN ISO 13397-1 provides a practical framework to demonstrate compliance, improve instrument reliability and support safe clinical reprocessing practices.
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Frequently Asked Questions
EN ISO 13397-1:1995 is a standard published by the European Committee for Standardization (CEN). Its full title is "Periodontal curettes, dental scalers and excavators - Part 1: General requirements (ISO 13397-1:1995)". This standard covers: Specifies the general material and performance requirements for periodontal curettes, dental scalers and excavators.
Specifies the general material and performance requirements for periodontal curettes, dental scalers and excavators.
EN ISO 13397-1:1995 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 13397-1:1995 has the following relationships with other standards: It is inter standard links to EN 1639:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 13397-1:1995 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)
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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