© ISO 2005 - All rights reserved
`
`ISO TC 1 06/SC 4 N
`
`Date: 2005~02-17
`
`ISO/CD 3630-1.2
`
`ISO TC 1 06/SC 4/WG 9
`
`Secretariat DIN
`
`Dentistry- Root-canal instruments - Part 1: General requirements
`
`Art dentaire -
`
`Instruments pour canaux radiculaires- Partie 1: Exigences generales
`
`Warning
`
`This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
`change without notice and may not be referred to as an International Standard.
`
`Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
`which they are aware and to prpvide supporting documentation.
`
`GOLD STANDARD EXHIBIT 2050
`US ENDODONTICS v. GOLD STANDARD
`CASE IPR2015-00632
`
`International Standard
`Document type:
`Document subtype:
`Document stage: (30) Committee
`Document language: E
`
`U:\KEL\IS0\1 06\SC4\WG09\3630-1\2ndCD3630-1\IS0_3630-1_(E).doc STD Version 2.2
`
`

`
`ISO/CD 3630-1.2
`
`Copyright notice
`
`This ISO document is a working draft or committee draft and is copyright-protected by ISO. While the
`reproduction of working drafts or committee drafts in any form for use by participants in the ISO standards
`development process is permitted without prior permission from ISO, neither this document nor any extract
`from it may be reproduced, stored or transmitted in any form for any other purpose without prior written
`permission from ISO.
`
`Requests for permission to reproduce this document for the purpose of selling it should be addressed as
`shown below or to I SO's member body in the country of the requester:
`
`[Indicate the full address, telephone number, fax number, telex number, and electronic mail address, as
`appropriate, of the Copyright Manager of the ISO member body responsible for the secretariat of the TC or
`SC within the framework of which the working document has been prepared .]
`
`Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.
`
`Violators may be prosecuted.
`
`ii
`
`© ISO 2005- All rights reserved
`
`

`
`ISO/CD 3630-1.2
`
`Contents
`
`Page
`
`Foreword ............................................................................................................................................................. v
`
`Introduction ........................................................................................................................................................ vi
`
`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 ........................................................................................................... 2
`Terms and definitions ........................................................................................................................... 2
`Symbols .................................................................................................................................................. 3
`
`Classification ......................................................................................................................................... 3
`
`Requirements ......................................................................................................................................... 3
`General ................................................................................................................................................... 3
`Standard sized (Type 1) instruments .................................................................................................. 4
`Taper-sized (Type 2) instruments) ....................................................................................................... 6
`Shape-sized (Type 3) instruments ....................................................................................................... 7
`Non-tapered sized (Type 4) instruments ............................................................................................. 8
`Non-uniform taper-sized (Type 5) instruments .................................................................................. 9
`Material ................................................................................................................................................. 10
`Dimensions .......................................................................................................................................... 10
`Mechanical requirements ................................................................................................................... 10
`Chemical requlrements ....................................................................................................................... 11
`
`Sampling ............................................................................................................................................... 11
`
`Testing .................................................................................................................................................. 11
`Visual Inspection ................................................................................................................................. 11
`Test conditions .................................................................................................................................... 11
`Measurement of dimensions .............................................................................................................. 12
`Resistance to fracture by twisting and angular deflection ............................................................. 12
`Stiffness ................................................................................................................................................ 14
`Handle and shank security ................................................................................................................. 15
`Corrosion test ...................................................................................................................................... 15
`Heat effects of sterilization ................................................................................................................. 16
`
`Designation, marking and identification ........................................................................................... 17
`General ................................................................................................................................................. 17
`Identification symbols ......................................................................................................................... 17
`
`Packaglng ............................................................................................................................................. 17
`
`Manufacturer's Instructions for use .................................................................................................. 17
`
`Labelling ............................................................................................................................................... 17
`
`Bibliography ...................................................................................................................................................... 19
`
`© ISO 2005- All rights reserved
`
`iii
`
`

`
`ISO/CD 3630·1.2
`
`Figures
`
`Figure 1 -Type 1: Standard-sized instrument: taper = 2 % - Dimensions, locations .............. ....... ................ 4
`
`Figure 2 - Tip length and angle ......................................................................................................................... 6
`
`Figure 3- Type 2: Taper-sized instrument: taper other than 2%- Dimensions, locations .............................. 7
`
`Figure 4 -Type 3: Shape-sized instrument: arc shape- Dimensions, locations .............................................. 8
`
`Figure 5- Type 4: Non-tapered instrument: zero taper- Dimensions, locations ............................................. . 8
`
`Figure 6- Apparatus for torque test ...................................... .......................................................................... 13
`
`Figure 7 - Details of test chuck ............................................................... ......................................................... 13
`
`Figure 8- Apparatus for bending test. .................................................................. ........................................... 14
`
`Figure 9 -
`
`Identification symbols for root-canal instruments ............................................................................ 17
`
`Tables
`
`Table 1 -Standard-sized instrument dimensions, size designation, and colour designation ........................... 5
`
`iv
`
`© ISO 2005 -All rights reserved
`
`

`
`ISO/CD 3630-1.2
`
`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/third/ ... edition cancels and replaces the first/second/ ... edition (ISO 3630-1 :1992), [clause(s) I
`subclause(s) I table(s) I figure(s) I annex(es)] of which [has I have] been technically revised.
`
`ISO 3630 consists of the following parts, under the general title Dentistry- Root-canal instruments:
`
`Part 1: General requirements
`
`Part 2: Enlargers
`
`Part 3: Condensers, pluggers and spreaders
`
`The following parts are under preparation:
`
`Part 4: Auxilliary instruments
`
`Part 5: Shaping and cleaning instruments
`
`© ISO 2005 - All rights reserved
`
`v
`
`

`
`ISO/CD 3630-1.2
`
`Introduction
`
`This reorganization of ISO 3630 is intended to present the requirements and test methods for root-canal
`instruments in an orderly manner. Part 1 of ISO 3630 defines general requirements and test methods.
`Subsequent parts provide the specific requirements and test methods, if applicable, for four areas of
`endodontic procedures. These parts are: enlargers, condensers, auxilliary instruments and cleaning and
`shaping instruments.
`
`With current use of Nickel-Titanium 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 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 obturating points (cones) specified in ISO 6877 [2] have to be aligned with the corresponding
`sizes for root-canal instruments specified in ISO 3630.
`
`vi
`
`© ISO 2005- All rights reserved
`
`

`
`COMMITTEE DRAFT
`
`ISO/CD 3630-1.2
`
`Dentistry- Root-canal instruments- Part 1: General
`requirements
`
`1 Scope
`
`This part of ISO 3630 specifies general requirements and test methods for root-canal instruments used for
`endodontic purposes, e g. enlargers, cleaning and shaping
`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, Dentistry- Terminology
`
`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 3696:1987, Water for analytical laboratory use- Specification and test methods
`
`ISO 6360-1 , Dentistry- Number coding system for rotary instruments - Part 1: General characteristics
`
`ISO 6360-2, Dentistry- Number coding system for rotary instruments- Part 2: Shape and specific
`characteristics
`
`ISO 6360-5, Dentistry- Number coding system for rotary instruments- Part 5: Specific characteristics of
`root-canal instruments
`
`ISO 8601, Data elements and interchange formats- Information interchange- Representation of dates and
`times
`
`ISO 13402:1995, Surgical and dental hand instruments- Determination of resistance against autoclaving,
`corrosion and thermal exposure
`
`ISO 15223, Medical devices- Symbols to be used with medical device labels, labelling and information to be
`supplied
`
`© ISO 2005 -All rights reserved
`
`1
`
`

`
`ISO/CD 3630-1.2
`
`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.
`
`3.1.1
`root-canal instrument
`instrument used to clean, shape, and fill root canal systems. In dentistry these instruments are also referred to
`as endodontic instruments
`
`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
`
`3.1.3
`non-standard-sized instrument
`root-canal instrument which has tip sizes not listed in Table 1
`
`3.1.4
`taper-sized instrument
`root-canal instrument of which the sizes are determined by the tip sizes and 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-tapered 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 which when tested according to 7.5, the average value of the tested samples 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 a root canal
`
`3.1.10
`tip portion of the Instrument
`the 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 into a handpiece
`
`2
`
`© ISO 2005- All rights reserved
`
`

`
`ISO/CD 3630-1.2
`
`3.1.13
`handle
`part of the root-canal instrument to be manipulated by the user by hand
`
`3.1.14
`operative part
`portion of the root-canal from the tip to the handle or shank
`
`3.2Symbols
`
`For the purposes of this part of ISO 3630, the following symbols apply.
`
`d1 diameter of the projection of the working part at the tip end (nominal size);
`
`d2 diameter at length /2;
`
`d3 diameter at the end of minimum length of working part, length /3;
`
`11
`
`12
`
`13
`
`14
`
`tip length;
`
`length for measuring point d2 ;
`
`length for measuring point d3; and minimum length of working part;
`
`length of operative part;
`
`15 overalllength.
`
`4 Classification
`
`For the purposes of this part of ISO 3630, root-canal instruments are classified according to the shape and
`taper of the tip size (see Figure 1) as following:
`-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-tapered sized instruments: zero taper;
`
`-Type 5: non-uniform taper-sized instrument.
`
`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 separate parts of the ISO 3630 series of standards.
`
`© ISO 2005- All rights reserved
`
`3
`
`

`
`ISO/CD 3630-1.2
`
`5.2 Standard sized (Type 1) instruments
`
`5.2.1 Length
`
`The length of the working part, /3, 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, 14, shall be within
`0,5 mm of the specified lengths.
`
`Test in accordance with 7.3.
`
`I
`\
`
`.......
`
`/
`
`:V
`
`~
`-s.
`
`Dimensions in millimetres
`
`13
`
`-c)
`lz
`f-~ -s.
`
`..
`
`~
`..;
`
`'S
`
`Figure 1 - Type 1: Standard-sized instrument: taper = 2 % - Dimensions, locations
`
`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)
`root-canal 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 ISO
`NOTE
`6360-1 and ISO 6360-2.
`
`5.2.3 Colour designation
`
`Table 1 gives the colour designation for each size of Type 1 instruments. These colours are used for size
`identification of the handle or shank. 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.
`
`4
`
`© ISO 2005- All rights reserved
`
`

`
`ISO/CD 3630-1.2
`
`Table 1 -Standard-sized instrument dimensions, size designation, and colour designation
`
`Nominal
`size
`
`006
`
`008
`
`010
`
`015
`
`020
`
`025
`
`030
`
`035
`
`040
`
`d1
`
`ref.
`
`0,06
`
`0,08
`
`0,10
`
`0,15
`
`0,20
`
`0,25
`
`0,30
`
`0,35
`
`0,40
`
`0,45
`
`d2
`
`to I.
`
`d3
`
`to I.
`
`12
`
`13 min.
`
`Colour
`designation
`
`012
`
`014
`
`016
`
`0,21
`
`0,26
`
`0,31
`
`0,36
`
`0,41
`
`0,46
`
`0,51
`
`0,38
`
`0,40
`
`0,42
`
`0,47
`
`0,52
`
`0,57
`
`0,62
`
`0,67
`
`0,72
`
`0,77
`
`±0,02
`
`± 0,02
`
`pink
`
`grey
`
`purple
`
`white
`
`yellow
`
`red
`
`blue
`
`green
`
`black
`
`white
`
`045
`
`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
`
`0,82
`
`0,87
`
`0,92
`
`1,02
`
`1 '12
`
`1,22
`
`1,32
`
`1,42
`
`1,52
`
`1,62
`
`1,72
`
`± 0,04
`
`±0,04
`
`3
`
`16
`
`yellow
`
`red
`
`blue
`
`green
`
`black
`
`white
`
`yellow
`
`red
`
`blue
`
`green
`
`black
`
`© ISO 2005 -All rights reserved
`
`5
`
`

`
`ISO/CD 3630-1.2
`
`5.2.5 Tip length and angle
`
`The tip length shall be within the limits specified by the minimum and maximum angle (!1min. to /1max.) as
`shown in Figure 2.
`
`Figure 2- Tip length and angle
`
`5.3 Taper-sized (Type 2) 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. If the manufacturer specifies the overall length, it shall be within
`1 ,0 mm of the specified length.
`
`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). In the case where the taper is 10% or more, the taper
`identification shall be 3 digits, i.e., "yyy".
`
`NOTE
`
`This instrument size designation is part of the 15-digit identification number defined in ISO 6360-1 .
`
`5.3.4 Diameter designation and diameters
`
`The diameter portion of the size designation shall be d1 (see Figure 3) expressed.in hundredths of a
`millimetre.
`
`Figure 3 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.
`
`6
`
`© ISO 2005- All rights reserved
`
`

`
`ISO/CD 3630-1.2
`
`13
`
`-
`~ -..;-
`
`'S-
`
`· =
`f??
`~ '
`
`~
`
`"'
`"1::1
`'S-
`
`~
`'S-
`
`{
`\
`
`........
`·-1-·
`
`/
`
`Key
`
`handle
`
`Figure 3 -Type 2: Taper-sized instrument: taper other than 2 % - Dimensions, locations
`
`5.3.5 Taper designation
`
`The taper portion of the size designation shall be tenths of a percent.
`
`NOTE 1
`
`For example, if the taper is 3% ( 0,03 mm per millimetre of length), the taper designation is "30".
`
`NOTE 2
`
`If the taper is defined as 11 %, (0,11 mm per millimetre of length), the taper identification is "110".
`
`5.3.6 Diameter colour identification
`
`When color coding is included, the colour sequence shall be light to dark, i.e., white, yellow, red, blue, green,
`and black. This sequence is repeated for instruments with more than six sizes.
`
`5.3.7 Taper colour and ring identification
`
`When colour coding is included 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, number of rings or marks shall be in
`sequence starting with one for the smallest percent taper.
`
`5.4 Shape-sized (Type 3) 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. If the manufacturer specified the overall length, it shall be within
`1 ,0 mm of the specified length.
`
`Test in accordance with 7.3.
`
`5.4.2 Size designation and diameters
`
`The size designation shall be in accordance with dimensions d1 in Table 1, such that d1 is the maximum
`diameter of the working part.
`
`© ISO 2005- All rights reserved
`
`7
`
`

`
`ISO/CD 3630-1.2
`
`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 1 is an example of the maximum diameter.
`
`NOTE
`
`Figure 4 shows an example of the maximum diameter measurement d1.
`
`* ·-·-·- B----·3---~~..__
`
`·
`
`t j
`~.....::::=..._-+~
`
`Figure 4- Type 3: Shape-sized Instrument: arc shape- Dimensions, locations
`
`5.4.3 Colour designation
`
`Table 1 gives the colour designation for each size of Type 3. These colours are used for size identification of
`the handle or shank. Colours of sizes not included in Table 1 are at the discretion of the manufacturer.
`
`5.5 Non-tapered sized {Type 4) 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. If the manufacturer specifies the overall length, it shall be within
`1,0 mm of the specified length.
`
`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 5 is an example of the non-tapered diameter.
`
`/I
`\!
`
`......
`
`/
`
`14
`
`.-....:'>.~~.:'>. .
`
`I 2
`r---.::--
`
`~
`s
`
`-.;;:
`
`·
`
`- ~ -
`
`/
`
`~
`
`N
`
`~ s
`
`Figure 5- Type 4: Non-tapered instrument: zero taper- Dimensions, locations
`
`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 handle or shank. Colours of sizes not included in Table 1 are at the discretion of the manufacturer.
`
`8
`
`© ISO 2005 - All rights reserved
`
`

`
`ISO/CD 3630-1.2
`
`5.6 Non-uniform taper-sized (Type 5) 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. If the manufacturer specifies the overall length, it shall be within
`1,0 mm of the specified length.
`
`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). In the case where the taper is 10% or more and where the taper
`includes 0,5 %, the taper identification shall be 3 digits, i.e., "yyy".
`
`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. The position of the diameters and lengths
`for all Type 5 root-canal instruments shall be as identified by the manufacturer. This requirement shall not
`preclude other sizes.
`
`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
`
`For example, if the taper is 3% ( 0,03 mm per millimetre of length), the taper designation is "30".
`
`NOTE 2
`
`If the taper is defined as 11 % (0, 11 mm per millimetre of length), the taper identification is "11 0".
`
`If the taper includes a 0,5 % portion and is defined as 4,5 % (0,45 mm per millimetre of length), the taper
`NOTE 3
`identification is "45".
`
`5.6.6 Diameter colour Identification
`
`When color coding is included, the colour sequence shall be light to dark, i.e., white, yellow, red, blue, green,
`and black. This sequence is repeated for instruments with more than six sizes.
`
`5.6.7 Taper colour and ring identification
`
`When colour coding is included 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.
`
`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.
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`© ISO 2005- Ail rights reserved
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`ISO/CD 3630-1.2
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`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 plastics 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 5.8 to 5.10 are fulfilled, the 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 I 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 instrument shall comply with the requirements of the specific
`insturment'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 mximum allowed speed. Instrument manufacturers shall identify the recommended maximum
`handpiece RPM for rotary instruments.
`
`5.9 Mechanical requirements
`
`5.9.1 Resistance to fracture by twisting
`
`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/CD 3630-1.2
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`5.9.2.1
`
`Handle and shank security
`
`Handles or shanks, when affixed to the operative end, 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 the shank when the stated torque is applied.
`
`Test in accordance with 7.6.
`
`5.10 Chemical requirements
`
`5.1 0.1 Resistance to corrosion
`
`Root-canal instruments claimed to be corrosion resistant shall, upon visual inspection, show no evidence of
`corrosion.
`
`Test in accordance with 7.7.
`
`5.1 0.2 Heat effects of sterilization
`
`The working part of the instruments shall show no signs of deterioration when visually inspected.
`
`The handles, upon visual inspection, shall show neither deformation nor colour change.
`
`Test in accordance with 7.8.
`
`6 Sampling
`
`Use sample of 10 instruments of each type and size for validating the following requirements:
`
`a) dimensions (see 5.8 and Table 1);
`
`b) materials (see 5.9);
`
`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 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) ac for a
`period of at least 1 hour prior to testing.
`
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`ISO/CD 3630-1.2
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`7.3 Measurement of dimensions
`
`7.3.1 Principle
`
`The measurement of dimensions of root-canal instruments include 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 gauges, or other suitable device.
`
`7.3.3 Procedure
`
`Insert the root-canal instrument to be measured into the measuring device.
`
`Measure the lengths /1, 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 1 mm from the end of the cutting portion. As an alternate 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 onto a plane at the tip of the
`instrument (datum line) which is perpendicular to the long axis (centre-line) of that instrument.
`
`When determining the tip length, the instrument is turned until the edges on the tip show approximately the
`same length.
`
`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 13 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 perfo