SIST EN ISO 13397-1:2000

• Abstract:

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

• 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)

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

SIST EN ISO 13397-1:2000 is the Slovenian adoption of EN ISO 13397-1:1995 for periodontal curettes, dental scalers and excavators. It specifies the general material and performance requirements for these dental hand instruments, including hardness, surface condition, corrosion and thermal resistance, and the strength of the working-end-to-handle union.

What does SIST EN ISO 13397-1:2000 specify?

SIST EN ISO 13397-1:2000 sets the general requirements for periodontal curettes, dental scalers and excavators. It covers the common requirements shared by the instrument families, while the series parts for specific instrument types are handled elsewhere in the ISO 13397 series.

The document is organized into clauses on scope, normative references, definitions, classification, material, requirements and test methods, plus an informative Annex A on dimension measurement.

Annex	What it covers
Annex A	An informative method for measuring dimensions, using an optical projector and related holding devices

What are the key requirements of SIST EN ISO 13397-1:2000?

SIST EN ISO 13397-1:2000 focuses on the features that determine whether a hand instrument is fit for clinical use and durable after reprocessing. The most important points are the working-end material, hardness class, surface quality, corrosion and thermal resistance, and the strength of the joint to the handle.

Material and classification

Clause 4 classifies the instruments by the Vickers hardness of the working end. Two hardness classes are given, and the manufacturer is required to state the appropriate hardness class for each instrument pattern or range of instruments in the documentation. In practice, this lets users match the instrument to the intended working performance and check that the delivered item is the right type.

Clause 5 requires the working end to be made of martensitic stainless steel complying with ISO 7153-1, or another material that still meets the performance requirements in Clause 6. The handle material may be selected by the manufacturer, but it must also satisfy the same performance requirements. That means material choice is open, but the finished instrument still has to pass the tests.

Surface condition and appearance

Clause 6.1 requires all surfaces to be visibly free from pores, crevices, grinding marks, residual scale, acid, grease, and residual grinding or polishing materials under normal vision. Satin finish must be uniform and smooth and reduce glare, while mirror finish must be polished to a highly reflective surface. In practice, these checks help avoid rough areas that can hold soil or indicate poor manufacture.

Hardness, corrosion and thermal exposure

Clause 6.2 requires the finished instrument to fall within the declared hardness class when tested to ISO 6507-2. Clause 6.3 requires no visible corrosion after the specified tests, and any blemish is treated as corrosion except on serrated martensitic stainless steel handles. Clause 6.4 requires no change in physical appearance after thermal exposure and that the Vickers hardness still remains within the stated range. This matters because the instrument must tolerate repeated cleaning and sterilization without losing function.

Joint strength and dimensions

Clause 6.5 requires the union between working end and handle not to loosen after tensile and torque testing. Clause 6.6 says the instrument shall have the design and dimensions specified in the appropriate part of ISO 13397. Annex A then gives one measurement method for checking dimensions on most dental hand instruments.

Test methods

Clause 7 requires the autoclave test, boiling water test and thermal test to be carried out in one operation for five cycles, followed by vigorous rubbing with a cloth. The autoclave, boiling water and thermal tests are taken from ISO 13402. Clause 7.5 then specifies a tensile test of 600 N for at least 5 s and a torque test of 400 Ncm for at least 5 s on the working-end-to-handle union. These tests show whether the instrument will stay intact under handling and reprocessing.

What terms does SIST EN ISO 13397-1:2000 define?

SIST EN ISO 13397-1:2000 uses the definitions from ISO 1942-3 for its dental instrument terms. The most important terms for reading the document are:

• Working end - the active part of the instrument that is subject to material, hardness, corrosion, thermal and joint-strength requirements.
• Handle - the part chosen by the manufacturer to support the working end, while still meeting the performance requirements.
• Vickers hardness - the hardness measure used to classify the working end and verify that heat exposure has not degraded it.
• Class 1 - the higher Vickers hardness range used for classifying the working end.
• Class 2 - the lower Vickers hardness range used for classifying the working end.
• Satin finish - a surface finish that is uniform, smooth and intended to reduce glare.
• Mirror finish - a highly reflective finish obtained by removing imperfections and polishing away grind marks.

Who uses SIST EN ISO 13397-1:2000?

SIST EN ISO 13397-1:2000 is used by manufacturers of periodontal curettes, dental scalers and excavators, by quality-control and test laboratories, and by purchasers or technical specifiers in dentistry. Manufacturers use it to design materials, choose surface finishes and document hardness classes. Test laboratories use it to verify hardness, corrosion resistance, thermal resistance and joint strength. Buyers and quality managers use it as a common acceptance basis when comparing products or checking conformity.

What changed in SIST EN ISO 13397-1:2000 from the previous edition?

SIST EN ISO 13397-1:2000 is identified as identical to EN ISO 13397-1:1995 and ISO 13397-1:1995. The document itself presents the 1995 edition as the basis for this standard.

Which standards are used with SIST EN ISO 13397-1:2000?

SIST EN ISO 13397-1:2000 relies on several referenced standards to define terms, materials and tests:

• ISO 1942-3 - provides the dental vocabulary terms used in Clause 3.
• ISO 6507-2 - specifies the Vickers hardness test method used for the working end.
• ISO 7153-1 - specifies stainless steel material for surgical instruments and is used for the working end material.
• ISO 13402 - provides the autoclave, boiling water and thermal tests used in Clause 7.

The ISO 13397 series is also named in the foreword:

• ISO 13397-2 - Dental curettes - Gr-type
• ISO 13397-3 - Dental scalers - H-type
• ISO 13397-4 - Dental excavators

What does the SIST EN ISO 13397-1:2000 document contain?

SIST EN ISO 13397-1:2000 contains the general requirements for these dental hand instruments, the hardness-based classification, the material rules for working end and handle, and the acceptance requirements for surface finish, corrosion resistance, thermal exposure and joint strength. It also gives the test sequence and the tensile and torque test conditions used to check the union between the working end and the handle.

Annex A provides a practical measurement method for dimensions. It describes an optical-projector setup, instrument holding options, alignment steps and horizontal, vertical and angular measurement steps, which makes it useful for design checks, production control and conformity testing.

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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