INTERNATIONAL
`STANDARD
`
`ISO
`3630-1
`
`Second edition
`2008-02-01
`
`Dentistry- Root-canal instruments -
`Part 1:
`General requirements and test methods
`
`Art dentaire- Instruments pour canaux radiculaires(cid:173)
`Partie 1: Exigences generales et methodes d'essai
`
`GOLD STANDARD EXHIBIT 2025
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`Reference number
`ISO 3630-1 :2008(E)
`
`©ISO 2008
`
`

`
`ISO 3630-1 :2008(E)
`
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`
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`COPYRIGHT PROTECTED DOCUMENT
`
`ISO 2008
`©
`All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
`electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
`!SO's member body in the country of the requester.
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`Published in Switzerland
`
`ii
`
`©ISO 2008- All rights reserved
`
`

`
`ISO 3630-1 :2008(E)
`
`Contents
`
`Page
`
`Foreword ............................................................................................................................................................ iv
`
`Introduction ........................................................................................................................................................ v
`
`1
`
`2
`
`3
`3.1
`3.2
`
`4
`
`5
`5.1
`5.2
`5.3
`5.4
`5.5
`5.6
`5. 7
`5.8
`5.9
`5.10
`
`6
`
`7
`7.1
`7.2
`7.3
`7.4
`7.5
`7.6
`7.7
`7.8
`
`8
`8.1
`8.2
`
`9
`
`10
`
`11
`
`Scope ..................................................................................................................................................... 1
`
`Normative references ........................................................................................................................... 1
`
`Terms, definitions and symbols .......................................................................................................... 1
`Terms and definitions ........................................................................................................................... 1
`Symbols ................................................................................................................................................. 3
`
`Classification ......................................................................................................................................... 3
`
`Requirements ........................................................................................................................................ 3
`General ................................................................................................................................................... 3
`Type 1: standard-sized instruments ................................................................................................... 3
`Type 2: taper-sized instruments .......................................................................................................... 5
`Type 3: shape-sized instruments ........................................................................................................ 6
`Type 4: non-taper-sized instruments .................................................................................................. 7
`Type 5: non-uniform taper-sized instruments ................................................................................... 8
`Material .................................................................................................................................................. 9
`Dimensions ............................................................................................................................................ 9
`Mechanical requirements ..................................................................................................................... 9
`Chemical requirements ...................................................................................................................... 10
`
`Sampling .............................................................................................................................................. 10
`
`Testing ................................................................................................................................................. 10
`Visual inspection ................................................................................................................................ 10
`Test conditions ................................................................................................................................... 10
`Measurement of dimensions ............................................................................................................. 11
`Resistance to fracture by twisting and angular deflection ............................................................. 11
`Stiffness ............................................................................................................................................... 13
`Handle and shank security ................................................................................................................ 14
`Corrosion test ..................................................................................................................................... 14
`Heat effects of sterilization ................................................................................................................ 15
`
`Designation, marking and identification .......................................................................................... 16
`General ................................................................................................................................................. 16
`Identification symbols ........................................................................................................................ 16
`
`Packaging ............................................................................................................................................ 16
`
`Manufacturer's instructions for use .................................................................................................. 16
`
`Labelling .............................................................................................................................................. 17
`
`Bibliography ..................................................................................................................................................... 18
`
`©ISO 2008- All rights reserved
`
`iii
`
`

`
`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
`liaison with ISO, also take part in the work. ISO collaborates closely with the
`non-governmental, in
`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
`
`

`
`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.
`
`The sizes of the root-canal obturating points (cones) specified in ISO 6877[41 have to be aligned with the
`corresponding sizes for root-canal instruments specified in ISO 3630.
`
`©ISO 2008- All rights reserved
`
`v
`
`

`
`
`
`

`
`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
`
`

`
`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
`
`

`
`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.
`
`d1 diameter of the projection of the working part at the tip end (reference size);
`
`d2 diameter at length 12;
`
`d3 diameter at the end of minimum length of working part, length /3;
`
`11
`
`!2
`
`!3
`
`14
`
`tip length;
`
`length for measuring point d2 ;
`
`length for measuring point d3 and minimum length of working part;
`
`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, !3, shall be a m1mmum of 16 mm unless otherwise specified by the
`manufacturer. The lengths of the working part, when specified, and of the operative part, 14 , shall be within
`± 0,5 mm of the specified lengths.
`
`Test in accordance with 7.3.
`
`©ISO 2008- All rights reserved
`
`3
`
`

`
`ISO 3630-1 :2008(E)
`
`{
`\
`
`M
`'<::!
`"$.
`
`·-
`
`· -1-E:~
`
`........
`. r-·
`/
`
`/3
`
`-t;"
`lz
`~ "$.
`_..----
`~'X'
`
`"'
`'<::!
`-e.
`
`X
`
`0
`· - C>
`C1'
`
`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 {d1) other than those listed in Table 1 are permitted. Figure 1 shows the position of the
`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.
`
`The designation (code number) with three digits is part of the 15-digit identification number specified in
`NOTE
`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 {11min. to l1max.) as
`shown in Figure 1.
`
`4
`
`© ISO 2008 -All rights reserved
`
`

`
`ISO 3630-1 :2008(E)
`
`Table 1 - Dimensions, size designation, and colour designation for Type 1
`(standard-sized instruments)
`
`Nominal
`size
`
`006
`
`008
`
`010
`
`015
`
`020
`
`025
`
`030
`
`035
`
`040
`
`045
`
`d1
`ref.
`
`0,06
`
`0,08
`
`0,10
`
`0,15
`
`0,20
`
`0,25
`
`0,30
`
`0,35
`
`0,40
`
`0,45
`
`Tolerance
`
`± 0,01
`
`± 0,02
`
`d2
`
`012
`
`014
`
`016
`
`0,21
`
`0,26
`
`0,31
`
`0,36
`
`0,41
`
`0,46
`
`0,51
`
`d3
`
`0,38
`
`0,40
`
`0,42
`
`0,47
`
`0,52
`
`0,57
`
`0,62
`
`0,67
`
`0,72
`
`0,77
`
`Dimensions in millimetres
`
`Tolerance
`
`12
`
`13 min.
`
`Colour
`designation
`
`pink
`
`grey
`
`purple
`
`white
`
`yellow
`
`red
`
`blue
`
`green
`
`black
`
`white
`
`yellow
`
`± 0,02
`
`3
`
`16
`
`050
`
`055
`
`060
`
`070
`
`080
`
`090
`
`100
`
`110
`
`120
`
`130
`
`140
`
`0,50
`
`0,55
`
`0,60
`
`0,70
`
`0,80
`
`0,90
`
`1,00
`
`1,10
`
`1,20
`
`1,30
`
`1,40
`
`0,56
`
`0,61
`
`0,66
`
`0,76
`
`0,86
`
`0,96
`
`1,06
`
`1,16
`
`1,26
`
`1,36
`
`1,46
`
`± 0,04
`
`0,82
`
`0,87
`
`0,92
`
`1,02
`
`1,12
`
`1,22
`
`1,32
`
`1,42
`
`1,52
`
`1,62
`
`1,72
`
`5.3 Type 2: taper-sized instruments
`
`5.3.1 Length
`
`± 0,04
`
`red
`
`blue
`
`green
`
`black
`
`white
`
`yellow
`
`red
`
`blue
`
`green
`
`black
`
`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 12 shall be 3 mm. The length /3 shall be 16 mm unless
`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.
`
`©ISO 2008- All rights reserved
`
`5
`
`

`
`ISO 3630-1 :2008(E)
`
`5.3.4 Diameter designation and diameters
`
`The diameter portion of the size designation shall be d1 (see Figure 2) expressed in hundredths of a millimetre.
`
`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.
`
`I
`\
`
`........
`··-1-·
`
`/
`
`/3
`
`~ ~
`
`'$.
`
`_.;
`
`~
`~ '
`
`~
`'$.
`
`-o'
`
`'$.
`
`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.
`
`6
`
`©ISO 2008- All rights reserved
`
`

`
`ISO 3630-1 :2008(E)
`
`5.4.2 Size designation and diameters
`
`The size designation shall be in accordance with dimensions d1 in Table 1 of ISO 3630-2:2000, such that d1 is
`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 d1.
`
`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 d1 tip diameter is the diameter of the working part.
`
`The zero taper shape shown in Figure 4 is an example of the non-tapered diameter.
`
`/4
`
`/3
`
`~
`
`~ -s.
`
`I
`I
`
`......
`. r-·
`
`/
`
`·-f--- -E::
`
`~
`
`-t;
`lz
`~ -s.
`
`~
`
`/
`
`-;;
`-s.
`
`Figure 4- Dimensions and locations for Type 4
`(non-taper-sized instruments; zero taper)
`
`©ISO 2008- All rights reserved
`
`7
`
`

`
`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 d1 in Table 1. This requirement shall not preclude other
`d1 sizes. The position of the diameters and lengths for all Type 5 root-canal instruments shall be as identified
`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.
`
`8
`
`©ISO 2008- All rights reserved
`
`

`
`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
`withstand normal operative procedures and sterilizing, if applicable. The type of material and the treatment
`shall be at the discretion of the manufacturer.
`
`If the requirements of 5.9 and 5.10 are fulfilled, the root-canal instruments are considered also to comply with
`the requirements of 5.7.
`
`5.8 Dimensions
`
`5.8.1 General
`
`The dimensions are given in millimetres.
`
`The dimensions designated d and l shall comply with the requirements of the specific instrument's respective
`tables and figures. Variations in shape and design are permitted.
`
`Test in accordance with 7.1, 7.2 and 7.3.
`
`5.8.2 Length
`
`The length of the operative part of the root-canal instrument shall comply with the requirements of the specific
`instrument's respective tables and figures.
`
`Test in accordance with 7.1, 7.2 and 7.3.
`
`5.8.3 Handle or shank
`
`The provision of the handle or shank is at the discretion of the manufacturer. Shanks shall be Type 1 as
`specified in ISO 1797-1 or ISO 1797-2.
`
`Instruments used with Type 1 shank as specified in ISO 1797-1 or ISO 1797-2 shall be operated with
`handpieces of a maximum allowed speed.
`Instrument manufacturers shall identify the recommended
`maximum revolutions per minute (rpm) for the handpiece.
`
`5.9 Mechanical requirements
`
`5.9.1 Resistance to fracture by twisting and angular deflection
`
`Root-canal instruments shall comply with the requirements specified in subsequent parts of ISO 3630.
`
`Test in accordance with 7.4.
`
`5.9.2 Resistance to bending
`
`Root-canal instruments shall comply with the requirements specified in subsequent parts of ISO 3630.
`
`Test in accordance with 7.5.
`
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`ISO 3630-1 :2008(E)
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`5.9.3 Handle and shank security
`
`Handles or shanks, when affixed to the operative part, shall be securely and permanently affixed. The
`instruments shall have no axial movement greater than 0,02 mm from the handle or shank. The instruments
`shall neither twist within the handle nor within the shank when the stated torque is applied.
`
`Test in accordance with 7.6.
`
`5.10 Chemical requirements
`
`5.10.1 Resistance to corrosion
`
`Root-canal instruments claimed to be corrosion resistant shall show no evidence of corrosion.
`
`Test in accordance with 7.7.
`
`5.1 0.2 Heat effects of sterilization
`
`The working parts of the root-canal instruments shall show no signs of deterioration.
`
`The handles shall show neither deformation nor colour change.
`
`Test in accordance with 7.8.
`
`6 Sampling
`
`Use a sample of 10 root-canal instruments of each type and size for validating the following requirements:
`
`a) dimensions (see 5.8 and Table 1);
`
`b) materials (see 5.7);
`
`c)
`
`resistance to fracture by twisting (see 5.9.1 );
`
`d)
`
`resistance to bending (see 5.9.2);
`
`e) handle and shank security (see 5.9.3);
`
`f)
`
`chemical requirements (see 5.1 0).
`
`For other requirements sampling is specified in the respective test clauses.
`
`7 Testing
`
`7.1 Visual inspection
`
`Visual inspection shall be carried out at normal visual acuity without magnification, unless otherwise specified.
`
`7.2 Test conditions
`Apparatus and root-canal instruments shall be conditioned in accordance with ISO 554 at (23 ± 2) oc for a
`period of at least 1 h prior to testing.
`
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`
`ISO 3630-1 :2008(E)
`
`7.3 Measurement of dimensions
`
`7.3.1 Principle
`
`The measurement of dimensions of root-canal instruments includes lengths, diameters and tapers.
`
`7.3.2 Apparatus
`
`7.3.2.1 Measuring device, with an accuracy of± 0,002 mm, such as an optical comparator, shadowgraph,
`measuring microscope, dial gauge or other suitable device.
`
`7.3.3 Procedure
`
`Insert the root-canal instrument to be measured into the measuring device.
`
`Measure the lengths 11, 12 and !3 of the root-canal instrument.
`
`Measure the diameters d1 and d3 of the root-canal instrument. If the working part is less than 16 mm measure
`the second diameter at a distance of 1 mm from the end of the cutting portion. As an alternative to measuring
`the d1 diameter, the d2 diameter may be measured at a location 3 mm from the tip point.
`
`The tip dimension is calculated from the projection of the taper of the working part on to a plane at the tip of
`the instrument (datum line) which is perpendicular to the long axis (centre-line) of that instrument.
`
`To determine the tip length, rotate the instrument to view the position that shows that the tip approximately
`forms a triangle or similar geometric form as shown in Figure 1.
`
`7.3.4 Expression of results
`
`The taper is determined by calculation using measured diameters d2 and d3. Taper is the difference between
`d3 and d2 divided by the distance between !3 and 12 . Taper tolerance is controlled solely by the tolerance of the
`specified diameters.
`
`7.4 Resistance to fracture by twisting and angular deflection
`
`7.4.1 Principle
`
`The test of resistance to fracture of root-canal instruments is performed by measuring the maximum torque
`and angular deflection for each root-canal instrument.
`
`7.4.2 Apparatus
`
`Apparatus for torque test, such as shown in Figure 5 or other suitable device, consisting of the
`7.4.2.1
`following parts.
`
`7.4.2.1.1
`
`Low-speed reversible geared motor, capable of revolving the test piece at 2 rpm.
`
`7.4.2.1.2
`
`Torque-measuring device, fixed on two linear ball-bearings mounted on the shaft of the device.
`
`7.4.2.1.3 Chuck with jaws made of soft brass, used to clamp the test piece 3 mm from the tip and
`coaxial with the torque axis (see Figure 6).
`
`7.4.2.1.4 Chuck with jaws made of hardened steel, for clamping the test piece at the shank.
`
`7.4.2.2
`
`Separate amplifier, for controlling the operation of the motor.
`
`7.4.2.3
`
`Digital display or strip chart recorder, for recording the torque and angular deflection.
`
`7.4.2.4
`
`Wire Cutter.
`
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`
`ISO 3630-1 :2008(E)
`
`1
`
`2
`
`4
`
`Dimensions in millimetres
`
`Key
`
`reversible gear motor
`chuck with hardened steel jaws
`chuck with soft brass jaws
`torque measuring device
`linear ball-bearing
`
`2
`3
`4
`5
`
`7.4.3 Procedure
`
`5
`
`3
`
`Figure 5 -Apparatus for torque test
`
`Remove the handle or shank with a suitable wire cutter at the point at which it is attached to the shaft of the
`root-canal instrument. Calibrate the torque-measuring device for the torque range of the sample to be tested.
`Set the test piece into the chuck of the geared motor leaving a maximum of 1 mm of the unground portion out
`of the chuck. Tighten the chuck.
`
`Slowly slide the torque-measuring device along the linear bearing until the tip of the test piece enters 3 mm
`into the brass jaws. Check to ensure that the test piece is straight and centered in the jaws (see Figure 6).
`Tighten the chuck. Since clamping will probably induce a pre-stress in the test piece, activate the geared
`motor in steps until the torque digital display or the strip chart recorder shows a zero reading. After ensuring
`that the geared motor is set for clockwise rotation as viewed from the test piece shank end, activate the device.
`The device shown is designed to st