SIST EN ISO 3630-1:2008
Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)
Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO 3630-1:2008)
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.
Zahnheilkunde - Wurzelkanalinstrumente - Teil 1 : Allgemeine Anforderungen und Prüfverfahren (ISO 3630-1:2008)
Der vorliegende Teil von ISO 3630 legt allgemeine Anforderungen an und Prüfverfahren für Wurzelkanalinstrumente für endodontische Anwendungen fest, z. B. Erweiterer, Instrumente zur Formgebung und Reinigung, Füllungsverdichter sowie Hilfsinstrumente. Zusätzlich enthalten sind allgemeine Größenbezeichnungen, Farbkennzeichnung, Verpackung und Identifikationssymbole.
Art dentaire - Instruments pour canaux radiculaires - Partie 1: Exigences générales et méthodes d'essai (ISO 3630-1:2008)
L'ISO 3630-1:2007 spécifie les exigences générales et les méthodes d'essai relatives aux instruments pour canaux radiculaires utilisés en endodontie, par exemple élargisseurs, instruments de mise en forme et de nettoyage, condenseurs et instruments auxiliaires. En outre elle couvre les désignations générales de dimensions, le code des couleurs, l'emballage et les symboles d'identification.
Zobozdravstvo - Instrumenti za zobni kanal - 1. del: Osnovne zahteve in preskusne metode (ISO 3630-1:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 3630-1:2008
01-julij-2008
1DGRPHãþD
SIST EN ISO 3630-1:2000
Zobozdravstvo - Instrumenti za zobni kanal - 1. del: Osnovne zahteve in preskusne
metode (ISO 3630-1:2008)
Dentistry - Root-canal instruments - Part 1: General requirements and test methods (ISO
3630-1:2008)
Zahnheilkunde - Wurzelkanalinstrumente - Teil 1 : Allgemeine Anforderungen und
Prüfverfahren (ISO 3630-1:2008)
Art dentaire - Instruments pour canaux radiculaires - Partie 1: Exigences générales et
méthodes d'essai (ISO 3630-1:2008)
Ta slovenski standard je istoveten z: EN ISO 3630-1:2008
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
SIST EN ISO 3630-1:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 3630-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
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 Zahnheilkunde - Wurzelkanalinstrumente - Teil 1:
1: Exigences générales et méthodes d'essai (ISO 3630- Allgemeine Anforderungen und Prüfverfahren (ISO 3630-
1:2008) 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
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
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© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3630-1:2008: E
worldwide for CEN national Members.
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EN ISO 3630-1:2008 (E)
Contents Page
Foreword.3
2
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EN ISO 3630-1:2008 (E)
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.
3
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INTERNATIONAL ISO
STANDARD 3630-1
Second edition
2008-02-01
Dentistry — Root-canal instruments —
Part 1:
General requirements and test methods
Art dentaire — Instruments pour canaux radiculaires —
Partie 1: Exigences générales et méthodes d'essai
Reference number
ISO 3630-1:2008(E)
©
ISO 2008
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ISO 3630-1:2008(E)
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ii © ISO 2008 – All rights reserved
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ISO 3630-1:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols. 1
3.1 Terms and definitions. 1
3.2 Symbols . 3
4 Classification. 3
5 Requirements . 3
5.1 General. 3
5.2 Type 1: standard-sized instruments . 3
5.3 Type 2: taper-sized instruments. 5
5.4 Type 3: shape-sized instruments. 6
5.5 Type 4: non-taper-sized instruments. 7
5.6 Type 5: non-uniform taper-sized instruments . 8
5.7 Material . 9
5.8 Dimensions. 9
5.9 Mechanical requirements. 9
5.10 Chemical requirements . 10
6 Sampling. 10
7 Testing . 10
7.1 Visual inspection . 10
7.2 Test conditions . 10
7.3 Measurement of dimensions . 11
7.4 Resistance to fracture by twisting and angular deflection. 11
7.5 Stiffness. 13
7.6 Handle and shank security . 14
7.7 Corrosion test . 14
7.8 Heat effects of sterilization . 15
8 Designation, marking and identification . 16
8.1 General. 16
8.2 Identification symbols. 16
9 Packaging . 16
10 Manufacturer's instructions for use. 16
11 Labelling . 17
Bibliography . 18
© ISO 2008 – All rights reserved iii
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ISO 3630-1:2008(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. 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.
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.
ISO 3630-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental
instruments.
This second edition cancels and replaces the first edition (ISO 3630-1:1992), which has been technically
revised.
ISO 3630 consists of the following parts, under the general title Dentistry — Root-canal instruments:
⎯ Part 1: General requirements and test methods
⎯ Part 2: Enlargers
⎯ Part 3: Condensers, pluggers and spreaders
⎯ Part 4: Auxiliary instruments
iv © ISO 2008 – All rights reserved
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ISO 3630-1:2008(E)
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.
[4]
The sizes of the root-canal obturating points (cones) specified in ISO 6877 have to be aligned with the
corresponding sizes for root-canal instruments specified in ISO 3630.
© ISO 2008 – All rights reserved v
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INTERNATIONAL STANDARD ISO 3630-1:2008(E)
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.
© ISO 2008 – All rights reserved 1
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ISO 3630-1:2008(E)
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
2 © ISO 2008 – All rights reserved
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ISO 3630-1:2008(E)
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.
d diameter of the projection of the working part at the tip end (reference size);
1
d diameter at length l ;
2 2
d diameter at the end of minimum length of working part, length l ;
3 3
l tip length;
1
l length for measuring point d ;
2 2
l length for measuring point d and minimum length of working part;
3 3
l length of operative part.
4
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, l , shall be a minimum of 16 mm unless otherwise specified by the
3
manufacturer. The lengths of the working part, when specified, and of the operative part, l , shall be within
4
± 0,5 mm of the specified lengths.
Test in accordance with 7.3.
© ISO 2008 – All rights reserved 3
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ISO 3630-1:2008(E)
Figure 1 — Dimensions and locations for Type 1
(standard-sized instruments; taper = 2 %)
5.2.2 Size designation and diameters
Table 1 gives the nominal sizes and dimensions for the working part to be used for Type 1 (standard-sized
instruments). Tip sizes (d ) other than those listed in Table 1 are permitted. Figure 1 shows the position of the
1
diameters and lengths for all Type 1 root-canal instruments. The nominal sizes shall correspond to the values
of the extended diameters at the tip of the working part in hundredths of a millimetre.
NOTE The designation (code number) with three digits is part of the 15-digit identification number specified in
ISO 6360-1 and ISO 6360-2.
5.2.3 Colour designation
Table 1 gives the colour designation for each size of Type 1 instrument. These colours are used on the handle
or shank and specify the size identification of the working part. Colours of sizes not included in Table 1 are at
the discretion of the manufacturer.
5.2.4 Tip shape
The shape of the tip is at the discretion of the manufacturer.
5.2.5 Tip length and angle
The tip length shall be within the limits specified by the minimum and maximum angle (l min. to l max.) as
1 1
shown in Figure 1.
4 © ISO 2008 – All rights reserved
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ISO 3630-1:2008(E)
Table 1 — Dimensions, size designation, and colour designation for Type 1
(standard-sized instruments)
Dimensions in millimetres
Nominal d Colour
1
d Tolerance d Tolerance l l min.
2 3 2 3
size ref. designation
006 0,06 012 0,38 pink
± 0,01
008 0,08 014 0,40 grey
010 0,10 016 0,42 purple
015 0,15 0,21 0,47 white
020 0,20 0,26 0,52 yellow
025 0,25 0,31 0,57 red
± 0,02
030 0,30 0,36 0,62 blue
035 0,35 0,41 0,67 green
± 0,02
040 0,40 0,46 0,72 black
045 0,45 0,51 0,77 white
3 16
050 0,50 0,56 0,82 yellow
055 0,55 0,61 0,87 red
060 0,60 0,66 0,92 blue
070 0,70 0,76 1,02 green
080 0,80 0,86 1,12 black
090 0,90 0,96 1,22 white
100 1,00 1,06 1,32 yellow
± 0,04 ± 0,04
110 1,10 1,16 1,42 red
120 1,20 1,26 1,52 blue
130 1,30 1,36 1,62 green
140 1,40 1,46 1,72 black
5.3 Type 2: taper-sized instruments
5.3.1 Length
The lengths of the working part and of the operative part shall be specified by the manufacturer, and shall be
within ± 0,5 mm of the specified lengths. The length l shall be 3 mm. The length l shall be 16 mm unless
2 3
otherwise specified by the manufacturer.
Test in accordance with 7.3.
5.3.2 Tip length and angle
The tip length and angle shall be at the discretion of the manufacturer.
5.3.3 Size designation
The designated instrument size shall be presented as “xxx yy”, where “xxx” is the diameter identification
(5.3.4) and “yy” is taper identification (5.3.5).
NOTE This instrument size designation is part of the 15-digit identification number defined in ISO 6360-1.
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ISO 3630-1:2008(E)
5.3.4 Diameter designation and diameters
The diameter portion of the size designation shall be d (see Figure 2) expressed in hundredths of a millimetre.
1
Figure 2 shows the position of the diameters and lengths for all Type 2 root-canal instruments. The nominal
sizes shall correspond to the values of the extended diameters at the tip of the working part in hundredths of a
millimetre.
Figure 2 — Dimensions and locations for Type 2
(taper-sized instruments; taper other than 2 %)
5.3.5 Taper designation
The taper portion of the size designation shall be in percent.
NOTE 1 If the taper is 3 % (0,03 mm per millimetre of length), the taper designation is “3” or “03”.
NOTE 2 If the taper is 12 % (0,12 mm per millimetre of length), the taper designation is “12”.
5.3.6 Diameter colour identification
When colour coding is used for a brand’s set of diameter sizes, the colour sequence shall be light to dark, i.e.,
white, yellow, red, blue, green and black. This sequence is repeated for root-canal instruments with more than
six sizes.
5.3.7 Taper colour and ring identification
When colour coding is used for a brand’s set of taper sizes, the colour sequence shall be light to dark, i.e.,
white, yellow, red, blue, green and black. This sequence is repeated for sets with more than six tapers.
When rings or other marks are included for a brand’s set of taper sizes, the number of rings or marks shall be
in sequence starting with one for the smallest percent taper.
5.4 Type 3: shape-sized instruments
5.4.1 Length
The lengths of the working part and of the operative part shall be specified by the manufacturer, and shall be
within ± 0,5 mm of the specified lengths.
Test in accordance with 7.3.
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ISO 3630-1:2008(E)
5.4.2 Size designation and diameters
The size designation shall be in accordance with dimensions d in Table 1 of ISO 3630-2:2000, such that d is
1 1
the maximum diameter of the working part. This requirement shall not preclude other sizes.
The shape of the working part is at the discretion of the manufacturer.
The arc shape type shown in Figure 3 is an example of the maximum diameter.
NOTE Figure 3 shows an example of the maximum diameter measurement d .
1
Figure 3 — Dimensions and locations for Type 3
(shape-sized instruments; arc shape)
5.4.3 Colour designation
ISO 3630-2 gives the colour designation for each size of Type 3 root-canal instrument. These colours are
used on the shank and specify the size identification of the working part. Colours of sizes not included in
ISO 3630-2 are at the discretion of the manufacturer.
5.5 Type 4: non-taper-sized instruments
5.5.1 Length
The lengths of the working part and of the operative part shall be specified by the manufacturer, and shall be
within ± 0,5 mm of the specified lengths.
Test in accordance with 7.3.
5.5.2 Size designation and diameters
Size designation and diameters follow the pattern of Table 1 but are not restricted to the sizes shown. Since
the working part is cylindrical in shape, the d tip diameter is the diameter of the working part.
1
The zero taper shape shown in Figure 4 is an example of the non-tapered diameter.
Figure 4 — Dimensions and locations for Type 4
(non-taper-sized instruments; zero taper)
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ISO 3630-1:2008(E)
5.5.3 Colour designation
Table 1 gives the colour designation for each size of Type 4. These colours are used for size identification of
the working part on the handle or shank. Colours of sizes not included in Table 1 are at the discretion of the
manufacturer.
5.6 Type 5: non-uniform taper-sized instruments
5.6.1 Length
The lengths of the working part and of the operative part shall be specified by the manufacturer, and shall be
within ± 0,5 mm of the specified lengths.
Test in accordance with 7.3.
5.6.2 Tip length and angle
The tip length and angle shall be at the discretion of the manufacturer.
5.6.3 Size designation
The designated instrument size shall be presented as “xxx yy”, where “xxx” is the diameter identification
(5.6.4) and “yy” is taper identification (5.6.5).
NOTE This instrument size designation is part of the 15-digit identification number defined in ISO 6360-1.
5.6.4 Diameter designation and diameters
The diameter portion of the size designation shall be d in Table 1. This requirement shall not preclude other
1
d sizes. The position of the diameters and lengths for all Type 5 root-canal instruments shall be as identified
1
by the manufacturer.
5.6.5 Taper designation
The taper portion of the size designation shall be tenths of a percent. The taper designation shall be identified
starting at the tip and sequentially to the last tapered portion as specified in 5.6.3.
NOTE 1 If the taper is 2 % (0,02 mm per millimetre of length), the taper designation is “2” or “02”.
NOTE 2 If the taper is 12 % (0,12 mm per millimetre of length), the taper designation is “12”.
NOTE 3 If the taper is considered a “half size” or portion of a whole number that number is either rounded up or down
as would be appropriate in standard numeric notation.
5.6.6 Diameter colour identification
When colour coding is used for a brand’s set of diameter sizes, the colour sequence shall be light to dark, i.e.,
white, yellow, red, blue, green and black. This sequence is repeated for root-canal instruments with more than
six sizes.
5.6.7 Taper colour and ring identification
When colour coding is used for a brand’s set of taper sizes, the colour sequence shall be light to dark, i.e.,
white, yellow, red, blue, green and black. This sequence is repeated for sets with more than six tapers. The
colour shall represent the first taper of the instrument.
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ISO 3630-1:2008(E)
When rings or other marks are included for a brand’s set of taper sizes, number of rings or marks shall be in
sequence starting with one for the smallest percent taper. The ring or mark shall represent the first taper of the
instrument.
5.7 Material
The operative part and the shank, if of one-piece, shall be made of any material and any treatment which
allows the instruments to meet the requirements of this part of ISO 3630.
The handles or shanks, when provided, shall be made of metal or plastic material of a quality suitable to
wit
...
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