Tandvård Rotkanalinstrument Del 1: Allmänna krav och provningsmetoder (ISO :2008)

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SVENSK STANDARD

Tandvård – Rotkanalinstrument –

Del 1: Allmänna krav och provningsmetoder (ISO 3630-1:2008) Dentistry – Root-canal instruments –

Part 1: General requirements and test methods (ISO 3630-1:2008)

S W E D I S H S TA N DA R D S

I N S T I T U T E

Fastställd/Approved: 2008-02-18 Publicerad/Published: 2008-03-10 Utgåva/Edition: 2

Språk/Language: engelska/English ICS: 11.060.20

SS-EN ISO 3630-1:2008

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engelska versionen av EN ISO 3630-1:2008.

Denna standard ersätter SS-EN ISO 3630-1, utgåva 1.

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This standard supersedes the Swedish Standard SS-EN ISO 3630-1, edition 1.

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EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM

EN ISO 3630-1

February 2008

ICS 11.060.20 Supersedes EN ISO 3630-1:1994

English Version

Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)

Art dentaire - Instruments pour canaux radiculaires - Partie 1: Exigences générales et méthodes d'essai (ISO 3630-

1:2008)

Zahnheilkunde - Wurzelkanalinstrumente - Teil 1:

Allgemeine Anforderungen und Prüfverfahren (ISO 3630- 1:2008)

This European Standard was approved by CEN on 7 January 2008.

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 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 Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T É E U R O P É E N D E N O R M A L I S A T I O N E U R O P Ä I S C H E S K O M I T E E F Ü R N O R M U N G

Management Centre: rue de Stassart, 36 B-1050 Brussels

Ref. No. EN ISO 3630-1:2008: E

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ii

Foreword

This document (EN ISO 3630-1:2008) 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 August 2008, and conflicting national standards shall be withdrawn at the latest by August 2008.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 3630-1:1994.

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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of ISO 3630-1:2008 has been approved by CEN as a EN ISO 3630-1:2008 without any modification.

iii SS-EN ISO 3630-1:2008 (E)

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iv

Introduction

The reorganization of ISO 3630 is intended to present the requirements and test methods for root-canal instruments in an orderly manner. This part of ISO 3630 defines general requirements and test methods.

Subsequent parts provide the specific requirements and test methods, if applicable, for two areas of endodontic procedures. These parts are enlargers, condensers and auxiliary instruments.

With current use of nickel-titanium (Ni-Ti) alloys for manufacture of root canal instruments a need for adequate expertise in their safe use is recommended. Instruments made of Ni-Ti can be easily broken near the tip if manufacturer's cautions are not understood and practiced. This part of ISO 3630 does not attempt to provide information for proper use of any instruments.

The sizes of the root-canal obturating points (cones) specified in ISO 6877^[4] have to be aligned with the corresponding sizes for root-canal instruments specified in ISO 3630.

SS-EN ISO 3630-1:2008 (E)

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1

Dentistry — Root-canal instruments — Part 1:

General requirements and test methods

1 Scope

This part of ISO 3630 specifies general requirements and test methods for root-canal instruments used for endodontic purposes, e.g. enlargers, shaping and cleaning instruments, condensers, and accessory instruments. In addition it covers general size designations, colour coding, packaging and identification symbols.

2 Normative references

The following referenced documents are indispensable for the application 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 554, Standard atmospheres for conditioning and/or testing — Specifications ISO 1942, Dental vocabulary (all parts)

ISO 1797-1:1992, Dental rotary instruments — Shanks — Part 1: Shanks made of metals ISO 1797-2:1992, Dental rotary instruments — Shanks — Part 2: Shanks made of plastics ISO 3630-2:2000, Dental root-canal instruments — Part 2: Enlargers

ISO 3696:1987, Water for analytical laboratory use — Specification and test methods ISO 6360-2, Dentistry — Number coding system for rotary instruments — Part 2: Shapes

ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times

ISO 13402, Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

3 Terms, definitions and symbols

3.1 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

SS-EN ISO 3630-1:2008 (E)

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2 3.1.1

root-canal instrument endodontic instrument

dental instrument designed to explore, shape, clean and fill root canal systems 3.1.2

standard-sized instrument

root-canal instrument throughout the range of sizes available having a uniform taper of 0,02 mm per millimetre of length

NOTE The nominal size of the root-canal instrument is listed in Table 1.

3.1.3

non standard-sized instrument

root-canal instrument which has other tip sizes than the standard-sized instrument NOTE The nominal size of the root-canal instrument is not listed in Table 1.

3.1.4

taper-sized instrument

root-canal instrument the sizes of which are determined by the tip sizes that have tapers other than 0,02 mm per millimetre of length

3.1.5

shape-sized instrument

root-canal instrument having a contoured working part with continuously varying profile 3.1.6

non taper-sized instrument

root-canal instrument having a cylindrical form along the long axis 3.1.7

non-uniform taper-sized instrument

root-canal instrument having more than one taper along the working part 3.1.8

flexible instrument

root-canal instrument whose average test value when tested according to 7.5, shall be 65 %, or less, of the value listed in the appropriate bending or stiffness table of referenced specifications

3.1.9

guided tip instrument

root-canal instrument having a tip which guides access within root canal systems 3.1.10

tip portion of the instrument

that part of the root-canal instrument which is intended as the point, the shape of which is at the discretion of the manufacturer

3.1.11 working part

portion of the root-canal instrument with an active cutting surface 3.1.12

shank

part of the root-canal instrument to be connected to a handpiece 3.1.13

handle

part of the root-canal instrument to be manipulated by the user by hand SS-EN ISO 3630-1:2008 (E)

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3 3.1.14

operative part

portion of the root-canal instrument from the tip to the handle or shank 3.2 Symbols

For the purposes of this document, the following symbols apply.

d₁ diameter of the projection of the working part at the tip end (reference size);

d₂ diameter at length l₂;

d₃ diameter at the end of minimum length of working part, length l₃; l₁ tip length;

l₂ length for measuring point d₂;

l₃ length for measuring point d₃ and minimum length of working part;

l4 length of operative part.

4 Classification

For the purposes of this document, root-canal instruments are classified according to the shape and taper of the tip size (see Figure 1) as follows.

Type 1: standard-sized instruments (taper 2 %);

Type 2: taper-sized instruments (taper other than 2 %);

Type 3: shape-sized instruments (arc shape);

Type 4: non-taper-sized instruments (zero taper);

Type 5: non-uniform taper-sized instruments (more than one taper).

5 Requirements

5.1 General

Specific root-canal instrument types, such as enlargers, have unique shapes which are not included here.

These cases are covered in ISO 3630-2 and ISO 3630-3.

5.2 Type 1: standard-sized instruments

5.2.1 Length

The length of the working part, l3, shall be a minimum of 16 mm unless otherwise specified by the manufacturer. The lengths of the working part, when specified, and of the operative part, l₄, shall be within r 0,5 mm of the specified lengths.

Test in accordance with 7.3.

SS-EN ISO 3630-1:2008 (E)

Tandvård Rotkanalinstrument Del 1: Allmänna krav och provningsmetoder (ISO :2008)

SVENSK STANDARD