INTERNATIONAL
`STANDARD
`
`ISO
`3630-1
`
`First edition
`1992-12-15
`
`Dental root-canal instruments
`
`Part 1:
`Files, reamers, barbed broaches, rasps, paste
`carriers, explorers and cotton broaches
`
`Instruments pour canaux radiculaires utilises en art dentaire -
`
`Partie 1: Limes, alesoirs, broches barbelees, rapes, bourre-pates, sondes
`exploratrices et broches porte-coton
`
`Reference number
`I SO 3630-1 : 1992( E)
`
`GOLD STANDARD EXHIBIT 2026
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`PGR2015-00019- Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`1 of 28
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1:1992(E)
`
`Contents
`
`Page
`
`1 Scope ................................................................................................. 1
`
`2 Normative references ... ..................... .. ................. ..................... ....... 1
`
`3 Nominal sizes, designation (code number) and corresponding
`............................................................. ........................ 2
`diameters
`
`4 Requirements
`
`.............................................................................. 2
`
`4.1 Material
`
`............................. ...... .................................................. 2
`
`4.2 Dimensional requirements
`
`....... ............................................... 3
`
`4.3 Mechanical requirements
`
`...................................................... 10
`
`4.4 Chemical requirements
`
`.......................................................... 11
`
`5 Sampling
`
`.................... .... .. .. .................... .. .. .... .... .... . ............ 11
`
`6 Testing
`
`........................... ................. ............................................ 12
`
`6.1 Visual inspection
`
`..................................................................... 12
`
`6.2 Measurement of dimensions
`
`.. .............. ....... ... .. ..................... 12
`
`6.3 Resistance t o fracture in torque and angular deflection
`
`12
`
`6.4 Resistance to bending
`
`............ ............ ........ ....... ... .................. 13
`
`6.5 Resistance to pull and twist: handle or shank
`
`.. .. ................ 14
`
`6.6 Resistance to corrosion
`
`......................................................... 14
`
`6.7 Heat effects of sterilization
`
`......................................... ........ ... 15
`
`7 Designation, marking and identification
`
`........... ........... .. .... .. ... 15
`
`7.1 Code for colour designation
`
`... .......... .............. .... .. .. ............... 15
`
`7.2 Additional designation
`
`..... .... .. ........... ..................................... 16
`
`7.3
`
`Identification symbols
`
`... ... ...... ................ ... .. .. ... ...... .... ... ....... ... 16
`
`8 Packaging
`
`.. ............ ................. .... .......... .... ...... .. .... .................... 17
`
`9 Marking
`
`.............................................................. .. ...... .. .............. 17
`
`\1'::
`ISO 1992
`All rights reserved. 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
`per mission in wr iting from the publisher.
`International Organi zatlon for Standardization
`Case Postale 56 • CH-121 1 Geneve 20 • Switzerland
`Printed in Switzerland
`
`ii
`
`2 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1:1992(E)
`
`Annex
`
`A Bibliography
`
`............... .. ..... .. .. ................. .......... ....... ... ......... ...... 19
`
`iii
`
`3 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1992(E)
`
`Foreword
`
`ISO (the International Organization for Standardization) is a worldwide
`federation of national standards bodies (ISO member bodies). Th e work
`of preparing International Standards is normally carried out through ISO
`technical comm ittees. 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, govern(cid:173)
`mental 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 standa rdization .
`
`Draft International Standards adopted by the technical committees are
`circulated to the member bodies for voting. Publication as an Inter(cid:173)
`nation al Standard requires approval by at least 75% of the member
`bodies casting a vote.
`
`Internation al Standard ISO 3630-1 was prepared by Technical Committee
`ISO/TC 106, Dentistry, Sub-Committee SC 4, Dental instruments.
`
`This first edition of ISO 3630-1 cancels and replaces ISO 3630:1984, of
`which it constitutes a technical revi sion.
`
`ISO 3630 consists of the following parts , under the general title Dental
`root-canal instruments:
`
`Part 1: Files, reamers. barbed broaches, rasps, paste carriers,
`explorers and cotton broaches
`
`Part 2: Enlargers
`
`Part 3: Condensers, pluggers and spreaders
`
`It is anticipated that additional types of instruments will form th e subject
`of additional future parts.
`
`Annex A of this part of ISO 3630 is for information only.
`
`iv
`
`4 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1:1992(E)
`
`Introduction
`
`This International Standard covers significant features of hand- and
`power-operated dental root canal instruments which are used by the
`dentist for the mechanical preparation of root canals for treatment. In
`dentistry these instruments are also referred to as endodontic instru(cid:173)
`ments.
`
`Part 1, in addition to the specific instruments indicated, includes general
`specifications. requirements and test methods which are applicable to
`all types of root-canal instruments.
`
`Attention is drawn to the International Standard on a number coding
`system, ISO 6360, which specifies a 15-digit number for the identification
`of dental rotary instruments of all types.
`
`v
`
`5 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`This page intentionally left blank
`
`6 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`INTERNATIONAL STANDARD
`
`ISO 3630-1 :1992(E)
`
`Dental root-canal instruments -
`
`Part 1:
`Files, reamers, barbed broaches, rasps, paste carriers,
`explorers and cotton broaches
`
`1 Scope
`
`This part of ISO 3630 specifies requirements and test methods for files, reamers , barbed broaches , ras ps , paste
`carriers, explorers and cotton broa ches. In addition it covers general specifications , test methods, information
`on the designation code and identification symbols for root-canal instruments independent of specific types.
`
`The requirements of this part of ISO 3630 shall become effective two years from the date of publication.
`
`2 Normative references
`
`The following standards contain provisions which, through reference in this text, constitute provisions of this
`part of ISO 3630. At the time of publication, the editions indicated were valid. All standards are subject to re(cid:173)
`vision, and parties to agreements based on this part of ISO 3630 are encourag ed to investigate the possibility
`of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain
`registers or currently vali d Intern ational Stand ards.
`
`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 6360-1:1985, Dental rotary instruments - Number coding system- Part 1: General characteristics.
`
`ISO 6360-2:1986, Dental rotary instruments - Number coding system- Part 2: Shape and specific character(cid:173)
`istics .
`
`ISO 8601 :1988, Data elements and interchange formats -
`times.
`
`Information interchange - Representation of dates and
`
`1
`
`7 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1:1992(E)
`
`3 Nominal sizes, designation (code number) and corresponding diameters
`
`Table 1 gives the nominal sizes for the working parts to be used for all dental root-ca nal instruments regardless
`of the type of instrument
`
`The nomin al sizes usually correspond to th e values of the extended diameters at the tip or the working part in
`hundredths of a mi lli metre.
`
`The design ation (code number) with three digits is part of the 15-digit identification nu mber laid down in
`ISO 6360-1 .
`
`Table 1 - Nominal sizes, designation (code
`number) and corresponding diameters
`Nominal size: designation
`Corresponding diameter
`mm
`(code number)
`
`008
`010
`01 2
`015
`017
`020
`025
`030
`035
`040
`045
`050
`055
`060
`070
`075
`080
`090
`100
`105
`110
`120
`130
`140
`150
`160
`170
`190
`
`0,08
`0,10
`0,12
`0,15
`0, 17
`0,20
`0,25
`0,30
`0,35
`0,40
`0,45
`0,50
`0,55
`0,60
`0,70
`0,75
`0,80
`0,90
`1,00
`1,05
`1,1 0
`1,20
`1,30
`1,40
`1,50
`1,60
`1,70
`1,90
`
`4 Requirements
`
`4.1 Material
`
`4.1.1 Working part
`
`The working part and the shaft, if one part, shall be made of stainless steel or ca rbon steel. The type of steel
`and the treatment shall be at the discretion of t he m anufacturer.
`
`2
`
`8 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 363G-1:1992(E)
`
`4.1.2 Handle, shank
`
`The handle, or shank, when affixed to the shaft, shall be made of metal or plastics material (see ISO 1797-1 and
`ISO 1797-2 respectively) of a quality suitable to withstand normal operative procedures . The type of material
`and the treatment shall be at the discretion of the manufacturer.
`
`If the requirements of 4.2 to 4.4 are fulfilled, the instruments are considered also to com ply with the requ ire(cid:173)
`ments of 4.1. 2.
`
`4.2 Dimensional requirements
`
`The dimensions are given in millimetres .
`
`The dimensional requi rements of the instruments shall comply with the respective tables and figu res; within the
`dimensiona l requi rements, variations in shape and design are permitted.
`
`Testing shall be carried out in accordance with 6.1 and 6.2 .
`
`4.2.1 Shanks
`
`Shanks shall be type 1 or 2 as specified in ISO 1797-1. In struments used with type 1 or 2 shanks shall be op(cid:173)
`erated with handpieces that are restricted to operate at slow speed. Except for paste carriers the handpieces
`shall have only an action of pulling motion andfor reciprocating motion (90° maxim um) unless otherwise
`specified.
`
`4.2.2 Files and reamers
`
`This clause covers the following types of instruments:
`
`Files, type H
`
`Files, type K
`
`Reamers, type K
`
`These files and reamers shall be in accordance with figure 1 and tables 2 to 4.
`
`NOTE 1 The dimensions are aligned with those of the dental obturating points (see ISO 6877) and dental absorbent points
`(see note 6).
`
`3
`
`9 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1992(E)
`
`,--Handle
`/
`
`X
`
`/1 ~ 0,5d1
`,, ~ 0,87d,
`
`The tip length shall be within the limits specified by the minimal and m aximal angle (11 min. to /1 max.).
`Shape and tip at the manufacturer's discretion.
`Handle or shank (type 1 or 2 of ISO 1797-1 ) at the manufactu rer's discretion.
`Taper along working part 0,02: 1
`Detail Y: see table 2
`d1 di ameter of the projection of the working part at the tip end (nominal size)
`diameter at length /2
`d2
`d3 diameter at the end of minimum length of working part, length /3
`tip length
`/1
`length for measuring point d2
`/2
`13
`length for measuri ng point d3 and minimum length of working part
`14
`length of operative end
`
`Figure 1 - Files. type H; files, type K; reamers, type K
`
`4
`
`10 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 363o-1 :1992(E)
`
`Table 2 - Typical flute form, detail Y
`Detail Y
`(see figure 1)
`
`Instrument
`
`Files, lype H
`
`Files, type K
`
`m--
`-&:9-
`Reamers, type K ~
`
`Table 3 - Dimensions and designation
`
`dz
`
`tol.
`
`d3
`
`tol.
`
`lz
`
`/3
`min.
`
`Colour
`designation
`
`0,40
`0.42
`0,47
`0,52
`0,57
`0,62
`0,67
`0,72
`
`0,77
`0,82
`0,87
`0,92
`1,02
`1.12
`
`1,22
`1,32
`1,42
`1,52
`1,62
`1,72
`
`± O,Q2
`
`± 0,04
`
`3
`
`16
`
`0,14
`0,16
`0,21
`0,26
`0,31
`0,36
`0.41
`0.46
`
`0,51
`0,56
`0,61
`0,66
`0,76
`0,86
`
`0,96
`1,06
`1,16
`1,26
`1,36
`1,46
`
`± 0,02
`
`± 0,04
`
`Table 4 -
`
`Length /4
`
`'· ± 0.5
`
`21
`25
`28
`31
`
`NOTE- Lengths of instruments not listed shall be
`within ± 0,5 mm of the stated length.
`
`grey
`purple
`white
`yellow
`red
`blue
`green
`black
`
`white
`yellow
`red
`blue
`green
`black
`
`white
`yellow
`red
`blue
`green
`black
`
`5
`
`Nominal size
`
`008
`010
`015
`020
`025
`030
`035
`040
`- -·---
`045
`050
`055
`060
`070
`080
`
`090
`100
`110
`120
`130
`140
`
`1----
`
`dl
`ref.
`
`0,08
`0,10
`0,15
`0,20
`0,25
`0,30
`0,35
`0,40
`
`0,45
`0,50
`0.55
`0,60
`0,70
`0,80
`
`0,90
`1,00
`1,10
`1,20
`1,30
`1,40
`
`11 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1992(E)
`
`4.2.3 Barbed broaches
`
`Barbed broaches shall be in accordance with figure 2 an d table 5.
`
`Shape of t ip at the manufacturer's
`discretion
`
`Hand use: design of handle at the
`manufacturer' s discretion
`
`d 1 diameter of the projection of the core at the tip end
`d2 diameter of core at length /2
`d3 diameter of core at length /3
`h
`height of barb
`length measured from tip point to base of first barb
`length for measuring point d2
`length for measuring point d3 and length of working part
`length of operative end
`
`/ 1
`12
`/ 3
`
`/4
`
`Figure 2 - Barbed broaches
`
`Table 5 - Dimensions and designation
`
`Nominal
`size11
`
`d1
`
`d2
`
`d3
`
`/2
`
`/3
`
`/4
`
`tol.
`
`tol.
`
`tol.
`
`± 1,5 min.
`
`020
`025
`030
`
`035
`040
`
`050
`060
`
`0,12
`0,14 ± 0,02
`0,16
`
`0,18 ± 0,03
`0,21
`
`0,15
`0,1 7 ± 0,02
`0,19
`-----
`0,21 ± 0,03
`0,24
`
`0,22
`0,24 ± 0,02
`0,26
`
`0,28 ± 0,03
`0,31
`
`3
`
`10,5
`
`20
`
`0,25 ± 0,04
`0,29
`
`0,28 ± 0,04
`0,32
`
`0,35 ± 0,04
`0,39
`
`h
`
`""
`
`0,075
`0,085
`0,095
`
`0,1 05
`0,120
`
`0,140
`0,160
`
`Number
`of barbs
`min.
`
`Designation
`Colour
`Number
`
`purple
`white
`yellow
`
`red
`blue
`
`green
`black
`
`0
`1
`2
`
`3
`4
`
`5
`6
`
`36
`
`--
`
`1) The nominal si2e designation is calculated by the core diamater d1 plus approximately twice the height of the barbs.
`
`6
`
`12 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1992(E)
`
`4.2.4 Rasps
`
`Rasps shall be in accorda nce with figure 3 and table 6.
`
`~
`~
`)> ~ 17"--- -- t t - --
`
`--
`
`.,
`
`/
`
`/4
`
`~
`
`ran
`
`e
`H dl
`
`1\
`
`1/
`
`Shape of tip and d esign of handle
`at the manufactu rer's d iscretion
`
`-""
`
`'Y
`
`X
`r:> ·-
`
`I'-
`
`----
`
`"
`- !3
`
`X
`
`d1 diameter of the projection of the core at the tip end
`d2 diameter of core at length 12
`diameter of core at length /3
`d3
`height of barb
`h
`length measured from tip point to base of first barb
`length for measuring point d2
`length for measuring point rl3 and length of working part
`length of operative end
`
`/ 1
`12
`/3
`14
`
`Figure 3 - Rasps
`
`Table 6 - Dimensions and designation
`
`Nominal
`size 1l
`
`025
`030
`035
`040
`045
`050
`
`t:4
`
`+0,03
`0
`
`0,15
`0,18
`0,21
`0,24
`0,27
`0.30
`
`d2
`
`d3
`
`12
`
`/3
`
`'·
`
`+0,03
`0
`
`0,20
`0,23
`0,26
`0,29
`0,32
`0,35
`
`•-0,03
`0
`
`0,31
`0,34
`0,37
`0,40
`0,43
`0,46
`
`± 1,5
`
`± 0,5
`
`3
`
`10,5
`
`25,5
`
`Number
`of
`barbs
`
`min_
`
`50
`
`h
`
`:::::
`
`0,05
`0,06
`0,07
`0,08
`0,09
`0, 10
`
`Designation
`
`Colour
`
`Number
`
`white
`yellow
`red
`blue
`green
`black
`
`1
`2
`3
`4
`5
`6
`
`1) The nominal size designation is calculated by the core diameter d1 plus approximately twice the height of the barbs.
`
`7
`
`13 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1992(E)
`
`4.2.5 Paste carriers
`
`Paste carriers shall be in accordance with figure 4 and tables 7 and 8.
`
`X
`
`X
`
`Shank type 1 or 2 in ISO 1797· 1,
`at the manu facturer's discretio n
`
`Winding of spiral at the manufacturer's discretion. The winding of the spiral shall be such as to convey the material to
`the tip of the instrument when rotated clockwise.
`Taper along working part 0,00 to 0,02:1
`d1 diameter of the projection of working part at the tip end (nominal size)
`length of working part
`/ 1
`length of operative end
`
`/ 2
`
`Figure 4 - Paste carriers
`
`Table 7 - Dimensions and designation
`
`Nominal size
`
`025
`030
`035
`040
`
`d1
`± 0,05
`
`0,25
`0,30
`0,35
`0,40
`
`'1
`min.
`
`16
`
`Colour
`
`red
`blue
`green
`black
`
`Desig ation
`Ring marking on shank
`
`I
`II
`Ill
`1111
`
`Table 8 - Length !2
`/2
`± 0,5
`
`for shank
`type 1
`
`21
`25
`29
`
`for shank
`type 2
`
`21
`25
`-
`
`NOTE - Lengths of instruments not listed shall be
`within ± 0,5 mm of the stated length.
`
`8
`
`14 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`4.2.6 Explorers and cotton broaches
`
`Exp lorers and cotton broaches shall be in accordance with figure 5 and table 9.
`
`ISO 3630-1 :1992(E)
`
`IYl
`
`-o
`
`~ -
`
`-
`
`-
`
`'4
`
`X
`
`~
`
`/?
`
`,:]'
`
`/
`I
`
`/3
`
`X
`
`t,
`
`Cross-section along operative end: round or polygonal at the manufacturer 's discretion
`Taper along oper ative end 0,007:1 , with tolerance of +~·003
`d1 diameter of the projection of the working part at the tip end (nominal size)
`d2 di ameter at the end o f the working part
`d3 diameter at the end of the operative part
`tip length
`/ 1
`length of working par t (length for measuring point d2 )
`length of oper ative end (length for measuring point d3 )
`overall length
`
`/ 2
`13
`/4
`
`Figure 5 - Explorers and cotton broaches
`
`Table 9 - Dimensions and designation
`
`Nomi nal
`size
`
`d1
`
`± 0,02
`
`4
`± 0,02
`
`d3
`
`max.
`
`/1
`
`lz
`
`± 1,5
`
`13
`
`± 0,5
`
`/4
`
`± 1,5
`
`Designation
`Colour
`Number
`
`012
`015
`017
`020
`025
`030
`
`0,12
`0,15
`0,17
`0,20
`0,25
`0,30
`
`0,20
`0,23
`0,25
`0,28
`0,33
`0,38
`
`0,9
`
`2 X d 1
`
`10,5
`
`25
`
`so
`
`white
`yellow
`red
`blue
`green
`black
`
`1
`2
`3
`4
`5
`6
`
`9
`
`15 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1:1992(E)
`
`4.3 Mechanical requirements
`
`4.3.1 Resistance to fracture in torque and angular deflection
`
`4.3.1.1 Files, reamers, barbed broaches and rasps
`
`The test piece shall not fracture and the minimum value For the resistance to fracture in torque and the mini(cid:173)
`mum value for the angular deflection given in table 10 shall be reached.
`
`Testing shall be carried out in accordance with 6.3.
`
`4.3.1.2 Other instruments
`
`NOTE 2
`
`For other root-canal instruments, requirements will be added as soon as as data are available.
`
`Nominal size
`
`Table 10 - Resistance to fracture In torque and angular deflection
`Resistance to fracture (torque)
`Angular deflection
`g·cm
`degrees
`min.
`min.
`
`Files
`
`Files
`
`Reamers
`
`type K
`
`type H
`
`type K
`
`Barbed
`broaches
`
`Rasps
`
`Files
`and
`reamers
`type K
`
`Files
`
`type H
`
`Barbed
`broaches
`
`Rasps
`
`008
`010
`015
`
`020
`
`025
`030
`035
`
`040
`045
`050
`
`055
`060
`070
`
`5
`6
`8
`
`18
`
`30
`45
`65
`
`100
`120
`170
`
`1)
`
`5
`5
`8
`
`12
`
`20
`35
`50
`
`65
`90
`120
`
`160
`250
`350
`
`5
`6
`8
`
`12
`
`20
`35
`50
`
`70
`95
`120
`
`I)
`
`-
`-
`-
`
`5
`
`6
`8
`10
`
`12
`-
`20
`
`-
`35
`-
`
`-
`-
`-
`
`-
`
`8
`10
`12
`
`20
`26
`35
`
`-
`-
`-
`
`360
`
`180
`
`120
`
`I)
`
`90
`
`-
`-
`-
`
`90
`
`-
`90
`-
`
`-
`-
`-
`
`-
`
`90
`
`-
`
`-
`-
`
`1) The minimum values for sizes greater than those listed above are not specified: all instruments of greater size can
`be assumed to have adequate resistance to fracture and angular denection.
`
`4.3.2 Resistance to bending
`
`4.3.2.1 Files, reamers, barbed broaches and rasps
`
`The values for the resistance to bending given in table 11 shall not be exceeded.
`
`Testing shall be carried out in accordance with 6.4.
`
`4.3.2.2 Other instruments
`
`NOTE 3
`
`For other root-canal instruments, requirements will be added as soon as data are available.
`
`10
`
`16 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1992(E)
`
`4.3.3 Resistance to pull and twist, handle or shank security
`
`This requirement does not apply to safety spiral paste carriers.
`
`Handles or shanks, when affixed to the operative end , shall be secure ly and permanently affixed. The instru(cid:173)
`ment shal l have no axial movement from the handle or shank and shall not twist within the handle or shank
`when torqued.
`
`Testing shall be carried out in accordance with 6.5.
`
`4.4 Chemical requirements
`
`4.4.1 Resistance to corrosion
`
`In struments made out of stainless steel shall show no evidence of corrosion. Instruments made out of metal
`not specifically treated against corrosion are not included.
`
`Testing shall be carried out in accordance with 6.6.
`
`4.4.2 Heat effects of sterilization
`
`The working part of instruments shall show no signs of deterioration.
`
`The handles, upon visual inspection. shall show no deformation or colour change.
`
`Testing shall be carried out in accordance with 6.7.
`
`Table 11 - Resistance to bending
`Bending moment
`g·cm
`max.
`
`Files
`type K
`
`Files
`
`type H
`
`Reamers
`
`type K
`
`Barbed
`broaches
`
`Rasps
`
`20
`25
`50
`80
`120
`150
`190
`250
`360
`450
`
`!)
`
`20
`20
`35
`65
`100
`135
`170
`220
`320
`520
`
`720
`920
`1 120
`
`20
`25
`50
`80
`120
`150
`220
`320
`375
`410
`
`I )
`
`- -
`
`-
`-
`25
`30
`40
`50
`80
`-
`120
`
`-
`170
`-
`
`-
`-
`-
`50
`70
`90
`140
`170
`210
`
`-
`-
`-
`
`Nominal size
`
`008
`010
`015
`020
`025
`030
`035
`040
`045
`050
`
`055
`060
`070
`
`1) The maximum values for sizes greater than tho se listed above are not specified: all instruments of greater size are
`such that flexibility is not a consideration.
`
`5 Sampling
`
`A samp le of 10 in strume nts shall be used of each type and size for validating the following require ments:
`
`a) dimensions (see 4.2) ;
`
`b) resistance to fracture in torque and angular denection (see 4.3.1);
`
`c) resistance to bending (see 4.3.2).
`
`11
`
`17 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1992(E)
`
`The method of procurement should be recorded in the test report.
`
`If all 10 samples pass, the product passes. If eight or fewer samples pass, the product fails. If nine samples
`pass, test five additional samples. When five additional samples are to be tested, all five shall pass For the
`product to be accepted.
`
`For other requirements sampling is specified in the respective test clauses.
`
`6 Testing
`
`6.1 Visual inspection
`
`For compliance with the requirements, visually inspect at normal visual acuity (unless otherwise specified).
`
`6.2 Measurement of dimensions
`
`The lengths, diameters and tapers are measured or calculated with a shadowgraph or other equipment of
`equivalent accuracy, for example dial gauges.
`
`The taper is determined by calculation using actual measured diameters d2 and d3 . Taper is the difference be(cid:173)
`tween d2 and d3 divided by the length of the taper. Taper tolerance is controlled solely by the tolerance of the
`specified diameters.
`
`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 deter(cid:173)
`mining the tip length, the intrument is turned until the edges on the tip show approximately the same length.
`
`6.3 Resistance to fracture in torque and angular deflection
`
`6.3.1 Test apparatus (see figure 6).
`
`1 .. Reversible gear motor
`I
`\ I
`\
`
`I
`
`Chuck with hardened
`\steel jaws
`
`~
`
`\Torque-measuring device
`\
`\
`\
`
`\
`
`I
`L- Linear ball-bearing
`
`Figure 6 - Apparatus for torque test
`
`6.3.1.1
`
`low-speed reversible geared motor capable of revolving the test piece at 2 min·· 1
`.
`
`6.3.1.2 Torque-measuring device fixed on two linear ball-bearings mounted on the shaft of the device.
`
`12
`
`18 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`6.3.1 .3 Chuck, with jaws made from soft brass for clamping the test piece at the tip along a length of 3 mm
`and coaxially with the to rque axis (see figure 7) .
`
`ISO 3630-1 :1992(E)
`
`.- Chuck with steel jaws
`\
`\
`\
`\
`
`Figure 7 - Test chuck detail
`
`6.3.1.4 Separate amplifier and digital display for controlling the operation of the motor and recording the
`torque and angul ar deflection .
`
`6.3.1.5 Chuck with jaws made from hardened steel for clamping the test piece at the shank.
`
`6.3.2 Procedure
`
`Remove the handles with a suitable wire cutter at the point at which the handle is attached to the instrum ent
`shaft. Ca librate the to rqu e-measuring device for the torque range of the sam ple to be tested. Set the test piece
`into the chuck of the geared motor leaving a maximu m of 1 mm of t he unground portion of the shank out of the
`chuck. Tighten the chuck.
`
`Slowly slide the torque-measuring device along the lin ear bearing until the tip of the test piece enters 3 m m into
`the brass j aws. Check to ensure that the test piece is straight and centred into the jaws (see figure 6) . Tighten
`the chuck. Since clamping will probably induce a prestre ss of the test piece, activate th e geared motor in steps
`until the torque digital display or the strip chart record er 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 test device
`will cease operation when the test piece fail s. Record the maximum torque and angular deflection for each
`pi ece tested.
`
`6.4 Resistance to bending
`
`6.4.1 Test apparatus
`
`The equipment as described in 6.3.1 is used with the modification of the clamping jaws and th e bending device
`or catch pin as shown in figure 8. The amplifier shall be capa ble of being set to a pre-selected angular de(cid:173)
`flection of 45° at which point the test stops.
`
`6.4.2 Procedure
`
`Remove t he handles with a suita bl e wire cutter at t he point at which th e handle is attached to the instrum ent
`shaft.
`
`Set t he apparatus to stop the angular deflection at 45°. Set the ch uck onto the shaft of t he torq ue-measuri ng
`device. Set the tip of the test piece into the jaws of the chuck perpendicular to the axis of the motor to a depth
`of 3 mm . Tighten the chuck. Mount the catch pin onto the motor shaft. Slide the torque-meas uring device along
`the lin ea r ball-bearing until the test piece is locat ed above the rotating pin. Rotate th e motor in the correct di(cid:173)
`rection in stages until the catch pin is lightly to uching the test piece. Ensure that the di splay shows zero. Acti(cid:173)
`vate the torque-measuring device. When the angul ar deflection has reached 45° t he test will stop. Record the
`applied force at the display for each piece tested.
`
`13
`
`19 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
` No further reproduction or networking is permitted. Distributed by Thomson Reuters (Scientific) LLC, www.techstreet.com.
`
`ISO 3630-1 :1 992(E)
`
`\ Reversible gear motor
`
`\
`
`Torque-measuring device --.,
`
`...-+--.
`\
`
`Stop
`
`I !--
`
`\ I
`
`i
`- 1 ·-· -
`/
`
`I
`I
`Catch pin · j
`
`Figure 8 - Apparatus for bending test
`
`6.5 Resistance to pull and twist: handle or shank
`
`Take as a sample five instruments of each type and size, and test for pull strength : take another five instru(cid:173)
`ments of each type and size for twist strength.
`
`6.5.1 Pull strength
`
`Grasp the operative end leaving 3 mm of the shaft exposed. Support the handle or shank to prevent axia l
`movement without restriction to the embedded operative end. Apply a mass of 2,25 kg axially. Measure and
`record the length of the operative end to determine any evidence of axial movement.
`
`Excluded are paste carriers with a spiral between th e working part and the shank which are designed to frac(cid:173)
`ture at this point if over-torqued.
`
`6.5.2 Twist strength
`
`Mount the handle or shank into the chucking device of a torque meter. The handle or shank shall be gripped
`along a portion behind the end of the embedded wire of the operative end. Insert the operative portion of the
`instrument leaving 3 mm of the shank exposed. Twist the instrument with a torq ue or 360 g·cm.
`
`Rotate the torque meter until the instrument wire slips within the handle or shank or until the minimum torque
`is obtained. It should be noted that for wire diameters up to 0,60 mm, the shaft may twist before slippage withi n
`the handle or shank.
`
`6.6 Resistance to corrosion
`
`6.6.1 Sampling and preparation of sample
`
`Take as the sample and for each test five instruments of each size. Scrub the test pieces with soap and water,
`rinse in hot water. dip in 95% (V/ V) ethanol or isopropyl alcohol (isopropanol; 2-propanol) and dry.
`
`6.6.2 Procedure
`
`Test pieces are subjected to one of the tests described in 6.6.2.1 and 6.6.2.2.
`
`6.6.2.1 Copper sulfate test
`
`Prepare copper sulfate solution as follows:
`
`copper(ll) sulfate pentahydrate (CuS04.5H 20): 4,0 g;
`
`sulfu ric acid {H2S04, p 1,84 gjml): 10,0 g;
`
`14
`
`20 of 28
`
`PGR2015-00019 - Ex. 1023
`US ENDODONTICS, LLC., Petitioner
`
`

`
`Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee