Copyrighted material licensed to Timothy Butler on 2014-07-24 for licensee's use only.
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`
`INTERNATIONAL
`STANDARD
`
`ISO
`36304
`
`First edition
`1992-12-15
`
`root-canal
`
`iinstruments
`
`Dental
`Part 1:
`rasps, Paste
`Files, reamers, barbed broaches,
`carriers, explorers and cotton broaches
`
`-
`
`pour canaux
`Instruments
`Partie
`1: Limes, aksoirs,
`exploratrices
`et broches
`
`utilises
`radiculaires
`broches
`barbelees,
`porte-coton
`
`-
`en art dentaire
`rapes, bourre-pates,
`
`sondes
`
`-
`----
`
`~_--_
`------.----
`----~
`---- .
`----
`---
`
`-----
`---
`-- _ _-- =--TT:z:~T---:
`
`---
`---
`
`Reference number
`ISO 36304 : 1992( E)
`
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`
`ISO 3630=1:1992(E)
`
`Contents
`
`Page
`
`1 Scope
`
`..,....................s... . . . . . . . . . . . . . . . . . . . . . . . ..*......... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`2 Normative
`
`references
`
`. . . . . . . . . . . . . . . . . . . . . ..~...............................................
`
`(Code number) and corresponding
`3 Nominal sizes, designation
`. . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.......................................................
`diameters
`
`1
`
`1
`
`2
`
`4 Requirements
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
`
`4.1 Material
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
`
`4.2 Dimensional
`
`requirements
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..‘...............
`
`3
`
`4.3 Mechanical
`
`requirements
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`
`IO
`
`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
`
`to 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
`
`. . . . ..*.............................................
`
`7 Designation, marking and identification
`
`............... ..................
`
`7.1 Code for colour designation
`
`. . . . . . . . . . ..*.....................................
`
`7.2 Additional designation
`
`. . . . . . . . . . . ..~...................................~.........
`
`15
`
`15
`
`15
`
`16
`
`7.3
`
`Identification Symbols
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
`
`8 Packaging
`
`..,.............................s........
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*....... 17
`
`9 Marking
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
`
`ISO 1992
`0
`in any form
`All rights reserved. No part of this publication may be reproduced or utilized
`or by any means, electronie or mechanical,
`including photocopying and microfilm, without
`Permission
`in writing
`from the publisher.
`International Organization
`for Standardization
`Case Postale 56 l CH-1211 Geneve 20 l Switzerland
`Printed
`in Switzerland
`
`ii
`
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`
`ISO 36304
`
`:1992(E)
`
`Annex
`
`A Bibliogt-aphy
`
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.................................
`
`19
`
`. . .
`Ill
`
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`
`ISO 3630=1:1992(E)
`
`Foreword
`
`is a worldwide
`for Standardization)
`ISO (the International Organization
`federation of national Standards bodies (ISO member bodies). The work
`of preparing
`International Standards
`is normally carried out through
`ISO
`technical
`committees.
`Esch 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-
`mental and non-governmental,
`in liaison with
`ISO, also take patt
`in the
`work.
`ISO collaborates
`closely with
`the
`International
`Electrotechnical
`Commission
`(IEC) on all matters of electrotechnical
`standardization.
`are
`Draft
`International Standards adopted by the technical
`committees
`Inter-
`circulated
`to the member bodies
`for voting. Publication
`as an
`national Standard
`requires approval
`by at least 75 % of the member
`bodies casting a vote.
`ISO 3630-1 was prepared by Technical Committee
`International Standard
`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
`revision.
`ISO 3630 consists of the following Parts, under
`root-canal
`insfruments:
`
`the general
`
`title Dental
`
`-
`
`-
`
`barbed
`reamers,
`Part 1: Files,
`explorers
`and cotton broaches
`
`broaches,
`
`rasps,
`
`Paste
`
`carriers,
`
`Part 2: Enlargers
`
`and spreaders
`pluggers
`Part 3: Condensers,
`-
`lt is anticipated
`that additional
`types of instruments will form the subject
`of additional
`future Parts.
`Annex A of this patt of ISO 3630 is for information only.
`
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`
`ISO 36304:1992(E)
`
`Introduction
`
`features of hand- and
`covers significant
`Standard
`International
`This
`dental
`root canal
`instruments which are used by the
`power-operated
`dentist
`for the mechanical
`preparation
`of root canals
`for treatment.
`In
`dentistry
`these
`instruments
`are also referred
`to as endodontic
`instru-
`ments.
`includes general
`indicated,
`instruments
`to the specific
`Part 1, in addition
`specifications,
`requirements
`and test methods which are applicable
`to
`all types of root-canal
`instruments.
`Standard on a number coding
`Attention
`is drawn
`to the
`International
`System, ISO 6360, which specifies a 15-digit number
`for the identification
`of dental
`rotary
`instruments of all types.
`
`V
`
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`This page intentionally
`
`left blank
`
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`
`INTERNATIONAL
`
`STANDARD
`
`ISO 3630=1:1992(E)
`
`Dental
`
`root-canal
`
`instruments
`
`-
`
`Part 1:
`Files, reamers, barbed broaches,
`explorers and cotton broaches
`
`rasps, Paste carriers,
`
`1 Scope
`
`rasps, Paste
`for files, reamers, barbed broaches,
`and test methods
`requirements
`This patt of ISO 3630 specifies
`information
`carriers, explorers and cotton broaches.
`In addition
`it covers general specifications,
`test methods,
`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 Zwo years
`
`from the date of publication.
`
`2 Normative
`
`references
`
`in this text, constitute provisions of this
`reference
`through
`The following Standards contain provisions which,
`part of ISO 3630. At the time of publication,
`the editions
`indicated were valid. All Standards are subject
`to re-
`Vision, and Parties to agreements
`based on this part of ISO 3630 are encouraged
`to investigate
`the possibility
`of applying
`the most
`recent editions of the Standards
`indicated below. Members of IEC and
`ISO maintain
`registers of currently valid
`International Standards.
`
`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
`istics.
`
`rotary
`
`instruments
`
`- Number
`
`coding System
`
`- Part 2: Shape and specific
`
`character-
`
`ISO 8601:1988, Data elements and interchange
`firnes.
`
`formats -
`
`Information
`
`interchange
`
`- Representation
`
`of dates and
`
`1
`
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`
`ISO 36304
`
`:1992(E)
`
`3 Nominal
`
`sizes, designation
`
`(Code number) and corresponding
`
`diameters
`
`Tabie 1 gives the nominal sizes for the working Parts to be used for all dental root-canal
`of the type of instrument.
`The nomina I sizes usually correspond
`hun dredths of a millimetre.
`The designation
`(Code number) with
`ISO 6360-1.
`
`three digits
`
`is par-t sf the 15-digit
`
`identification
`
`to the values of the extended dia
`
`rs at the tip or the working part in
`
`instruments
`
`regardless
`
`number
`
`laid down
`
`in
`
`(Code
`sizes, designation
`1 - Nominall
`Table
`number)
`and corresponding
`diameters
`Corresponding
`diameter
`Nominal size: designation
`mm
`(Code number)
`
`008
`010
`012
`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,lO
`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 ,oo
`1,05
`1,lO
`1,20
`1,30
`1,40
`1,50
`1,60
`1,70
`1,90
`
`4 Requirements
`
`4.1 Material
`
`4.1.1 Working
`
`part
`
`if one Part, shail be made of stainless steel or carbon steel. The type of steel
`The working part and the shaft,
`and the treatment
`shall be at the discretion of the manufacturer.
`
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`
`ISO 363001:1992(E)
`
`4.1.2
`
`Handle,
`
`shank
`
`(see ISO 1797-1 and
`The handle, or shank, when affixed to the shaft, shall be made of metal or plastics material
`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
`ments of 4.1.2.
`
`also to comply with the require-
`
`4.2 Dimensional
`
`requirements
`
`in millimetres.
`are given
`The dimensions
`shall comply with the respective
`requirements
`of the instruments
`The dimensional
`dimensional
`requirements,
`variations
`in shape and design are permitted.
`
`Testing shall be carried out in accordance with 6.1 and 6.2.
`
`4.2.1
`
`Shanks
`
`tables and figures; within
`
`the
`
`used with type 1 or 2 shanks shall be op-
`in ISO 1797-1. Instruments
`Shanks shall be type 1 or 2 as specified
`to operate at slow Speed. Except
`for Paste carriers
`the handpieces
`erated with handpieces
`that are restricted
`shall have only an action of pulling motion and/or
`reciprocating motion
`(90’ maximum)
`unless otherwise
`specified.
`
`4.2.2
`
`Files and
`
`reamers
`
`This clause covers
`
`the following
`
`types of instruments:
`
`Files, type H
`
`Files, type K
`
`type K
`Reamers,
`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).
`
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`
`r
`
`Handle
`
`X
`
`\
`
`~-~-_-
`
`-L
`
`o\
`
`i
`
`-
`
`/
`.’
`I
`
`0
`0
`-
`
`I l
`I
`
`‘\
`
`ISO 36304
`
`:1992(E)
`
`,’
`.
`
`‘\
`
`6
`
`1)
`
`-(
`
`1, 3 O,Sd,
`1, 4 0,87d,
`
`thc limits specified by the minimal and maximal angle (I, min. to I, max.).
`The tip length shall be within
`Shape and
`tip at the manufacturer’s
`discretion.
`Handle or shank (type 1 or 2 of ISO 17974) at the manufacturer’s
`Taper along working
`part 0,02:1
`Detail Y: see table2
`of the projection
`diameter
`4
`diameter at length Zz
`dz
`(;E3 diameter at the end of minimum
`I,
`tip length
`Point LI*
`Zz
`length
`for measuring
`for measuring Point d3 and minimum
`Z3
`length
`length of operative end
`
`24
`
`Figure 1 - Files, type H: files, type K; reamers,
`
`type K
`
`discretion.
`
`of the working
`
`part at the
`
`tip end
`
`( nominal
`
`size)
`
`length of working Part, lengt h *3
`
`length of working part
`
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`
`ISO 3630=1:1992(E)
`
`form, detail Y
`Detail Y
`(see figure 1)
`
`Table
`
`2 - Typical
`
`flute
`
`Instrument
`
`Files,
`
`type H
`
`Files, type K
`
`Reamers,
`
`type K
`
`Nominal size
`
`ref. T
`
`di
`
`Table
`
`3 - Dimensions
`
`and designation
`
`d2
`
`toi.
`
`d3
`
`toi.
`
`13
`min.
`
`Colour
`designation
`
`008
`010
`015
`020
`025
`030
`035
`040
`
`045
`050
`055
`060
`070
`080
`
`090
`100
`110
`120
`130
`140
`
`0,08
`0,lO
`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 ,oo
`1,lO
`1,20
`1,30
`1,40
`
`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
`-
`
`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
`
`+ 0,02
`-
`
`+ 0,04
`-
`
`3
`
`16
`
`W-Y
`purple
`white
`yellow
`red
`blue
`green
`black
`
`white
`yellow
`red
`blue
`green
`black
`
`white
`yellow
`red
`blue
`green
`black
`
`Table
`
`4 -
`
`Length 2’
`
`*4
`+ 0,5
`-
`
`21
`25
`28
`31
`
`NOTE - Lengths of instruments
`within k 0,5 mm of the stated
`
`not listed shall be
`length.
`
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`
`ISO 36304:1992(E)
`
`4.2.3
`
`Barbed
`
`broaches
`
`Barbed broaches shall be in accordance with figure2 and table5.
`
`Shape of tip at the manufacturer’s
`discretion
`
`Hand use: design of handle at the
`manufacturer’s
`discretion
`
`4
`
`d2
`
`4
`
`h
`
`4
`
`l2
`
`23
`
`24
`
`diameter of the projection of the core at the tip end
`diameter of core at length
`l2
`diameter of core at length Z3
`height of barb
`tip Point to base of first barb
`from
`length measured
`for measuring Point d2
`length
`length
`for measuring Point d3 and length of working part
`length of operative end
`
`Figure
`
`2 - Barbed
`
`broaches
`
`Nominal
`sizel)
`
`020
`025
`030
`
`035
`040
`
`0,12
`0,14
`0,16
`
`0,18
`0,21
`
`050
`060
`
`0,25
`0,29
`
`I
`I
`I
`1) The nominal size designation
`
`Table 5 - Dimensions and designation
`13
`24
`
`-
`
`Liz
`
`toi.
`
`toi.
`
`toi.
`
`* 0,02
`
`0,15
`0,17
`0,19
`
`-f- 0,02
`
`0,22
`0,24
`0,26
`
`It OP
`
`* 195
`
`min.
`
`3
`
`IO,5
`
`20
`
`I
`
`I
`
`1
`is calculated by the core diamater d, plus approximately
`
`h
`
`z
`
`0,075
`0,085
`0,095
`
`0,105
`0,120
`
`0,140
`0,160
`
`Number
`--
`.
`of bat-w
`min.
`
`Designation
`
`Number
`
`2olour c
`
`I
`
`36
`
`purple
`white
`yellow
`
`red
`blue
`
`green
`black
`
`0
`1
`2
`
`3
`4
`
`5
`
`twice the height of the barbs.
`
`~~
`
`I
`
`12 of 28
`
`IPR2015-00632 - Ex. 1016
`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.
`
`7
`
`4.2.4
`
`Rasps
`
`Rasps shall be in accordance with figure3 and table6.
`
`ISO 36304:1992(E)
`
`r Handle
`
`Shape of tip and design of handle
`at the manufacturer’s
`discretion
`
`4
`d2
`
`d3
`h
`4
`22
`
`*3
`4
`
`diameter of the projection of the core at the tip end
`diameter of core at length Z2
`diameter of core at length Z3
`height of barb
`tip Point to base of first barb
`from
`length measured
`length
`for measuring Point d2
`tzi3 and length of working
`length
`for measuring
`Point
`length of operative end
`
`part
`
`Figure
`
`3 - Rasps
`
`-I-
`
`Nominal
`size 1)
`
`025
`030
`035
`040
`045
`050
`
`4
`
`+0,03
`0
`
`0,15
`0,18
`0,21
`0,24
`0,27
`0,30
`
`4
`
`to,o3
`0
`0,20
`0,23
`0,26
`0,29
`0,32
`0,35
`
`I
`
`Table
`l
`
`d3
`
`+ 0,03
`0
`
`0,31
`0,34
`0,37
`0,40
`0,43
`0,46
`
`6 - Dimensions
`
`and designation
`
`*2
`
`+ 13
`
`3
`
`10,5
`
`25,5
`
`Number
`of
`barbs
`
`min.
`
`Designation
`
`Colour
`
`Number
`
`0,05
`0,06
`0,07
`0,08
`0,09
`0,lO
`
`white
`yellow
`red
`blue
`green
`black
`
`50
`
`I
`
`1
`2
`3
`4
`5
`6
`
`1) The nominal size designation
`
`is calculated by the core diameter d, plus approximately
`
`twice
`
`the height of the barbs.
`
`13 of 28
`
`IPR2015-00632 - Ex. 1016
`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
`
`figure4
`
`and
`
`tables
`
`7 and 8.
`
`Shank type 1 or 2 in ISO 1797-1,
`at the manufacturer’s
`discretion
`
`discretion. The winding of the spiral shall be such as to convey
`Winding of spiral at the manufacturer’s
`the tip of the instrument when rotated clockwise.
`Taper along working part 0,OO to 0,02:1
`d,
`diameter of the projection of working part at the tip end (nominal size)
`length of working part
`length of operative end
`
`4
`12
`
`the material
`
`to
`
`Figure
`
`4 - Paste carriers
`
`Nominal size
`
`025
`030
`035
`040
`
`Table
`4
`+ 0,05
`
`7 - Dimensions
`4
`min.
`
`0,25
`0,30
`0,35
`0,40
`
`16
`
`and designation
`
`Colour
`
`red
`blue
`green
`black
`
`Desiguation
`Ring marking on shank
`
`I
`II
`Ill
`Ill1
`
`Table
`
`for shank
`tYPe 1
`
`21
`25
`29
`
`8 - Length Z2
`l2
`+ 0,5
`-
`
`for shank
`tYPe 2
`21
`25
`-
`
`NOTE - Lengths of instruments
`within + 0,5 mm of the stated
`
`not listed shall be
`length.
`
`14 of 28
`
`IPR2015-00632 - Ex. 1016
`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
`
`Explorers and cotton broaches shall be in accordance with figure 5 and table9.
`
`ISO 3630=1:1992(E)
`
`discretion
`
`along operative end: round or polygonal at the manufacturer’s
`Cross-section
`Taper along operative end 0,007:1, with
`tolerante
`of
`‘$““”
`d,
`diameter of the projection
`of the working part at the tip end (nominal size)
`d2 diameter at the end of the working part
`d3 diameter at the end of the operative
`part
`tip length
`4
`length of working part (length
`22
`length of operative
`end (length
`13
`Zd Overall
`length
`
`for measuring Point d2 )
`for measuring Point d3 )
`
`Figure
`
`5 - Explorers
`
`and cotton broaches
`
`Table
`
`d3
`
`max.
`
`Nominal
`size
`
`012
`015
`017
`020
`025
`030
`
`4
`
`R;
`
`+ 0,02
`-
`
`0,12
`0,15
`0,17
`0,20
`0,25
`0,30
`
`+ 0,02
`-
`
`0:23
`
`0,25
`0,28
`0,33
`0,38
`
`I
`
`03
`
`2 x d,
`
`10,5
`
`25
`
`50
`
`9 - Dimensions
`fl
`
`and designation
`
`22
`
`
`
`+v -
`
`f3
`
`- + 0,5
`
`4
`+ 1,5
`-
`
`Designation
`Colour
`Number
`
`white
`yellow
`red
`blue
`green
`black
`
`1
`2
`3
`4
`5
`6
`
`9
`
`15 of 28
`
`IPR2015-00632 - Ex. 1016
`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.
`
`020
`
`02s
`030
`035
`
`040
`04s
`OS0
`
`05s
`060
`070
`
`18
`
`30
`45
`65
`
`100
`120
`170
`
`1)
`
`12
`
`20
`35
`50
`
`65
`90
`120
`
`160
`250
`350
`
`12
`
`20
`35
`50
`
`70
`95
`120
`
`1)
`
`6
`8
`10
`
`12
`-
`20
`
`-
`35
`-
`
`8
`10
`12
`
`20
`26
`35
`
`-
`-
`-
`
`360
`
`120
`
`1)
`
`90
`
`90
`
`-
`90
`-
`
`90
`
`-
`-
`-
`
`for sizes greater
`values
`1) The minimum
`be assumed
`to have adequate
`resistance
`
`listed above are not specified: all instruments
`than those
`to fracture and angular deflection.
`
`of greater size tan
`
`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
`
`ISO 363091:1992(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
`
`for the resistance
`The test piece shall not fracture and the minimum value
`mum value
`for the angular deflection given
`in table 10 shall be reached.
`
`to fracture
`
`in torque and the mini-
`
`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.
`
`Table
`
`in torque and angular deflection
`to fracture
`10 - Resistance
`Angular deflection
`Resistance
`to fracture
`(torque)
`degrees
`gxm
`min.
`min.
`
`Files
`and
`reamers
`tYPe K
`
`Files
`
`tYPe t-l
`
`180
`
`Barbed
`broaches
`
`Rasps
`
`-
`-
`-
`
`-
`-
`-
`
`-
`
`Nominal size
`
`008
`010
`015
`
`Files
`
`Files
`
`Reamers
`
`tYPe K
`5
`6
`8
`
`tYPe H
`5
`5
`8
`
`type K
`5
`6
`8
`
`Barbed
`broaches
`
`Rasps
`
`-
`-
`-
`
`5
`
`-
`-
`-
`
`-
`
`16 of 28
`
`IPR2015-00632 - Ex. 1016
`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 36304:1992(E)
`
`4.3.3
`
`Resistance
`
`to puii and
`
`twist, handle or shank security
`
`does not apply to safety spiral Paste carriers.
`This requirement
`Handles or shanks, when affixed
`to the operative end, shall be securely and permanently
`ment shall have no axial movement
`from the handle or shank and shall not twist within
`when torqued.
`Testing shall be carried out in accordance with 6.5.
`
`affixed. The instru-
`the handle or shank
`
`4.4 Chemical
`
`requirements
`
`4.4.1 Resistance
`
`to corrosion
`
`steel shall show no evidente of corrosion.
`Instruments made out of stainless
`not specifically
`treated against corrosion are not included.
`Testing shall be carried out in accordance with 6.6.
`
`Instruments made out of metal
`
`4.4.2
`
`Heat effects of steriiization
`
`shall show no signs of deterioration.
`The working part of instruments
`The handles, upon visual
`inspection,
`shall show no deformation or colour Change.
`Testing shall be carried out in accordance with 6.7.
`
`Tabie
`
`11 - Resistance
`
`Files
`tYPe K
`
`20
`25
`50
`80
`120
`150
`190
`250
`360
`450
`
`1)
`
`Files
`tYPe H
`
`20
`20
`35
`65
`100
`135
`170
`220
`320
`520
`
`720
`920
`1 120
`
`to bending
`Bending moment
`g-cm
`max.
`Reamers
`tYPe K
`
`20
`25
`50
`80
`120
`150
`220
`320
`375
`410
`
`1)
`
`Barbed
`broaches
`
`Rasps
`
`-
`-
`25
`30
`40
`50
`80
`-
`120
`
`-
`170
`-
`
`-
`-
`-
`50
`70
`90
`140
`170
`210
`
`-
`-
`-
`
`Nominal size
`
`008
`010
`015
`020
`02s
`030
`03s
`040
`045
`050
`
`055
`060
`070
`
`1) The maximum
`such that flexibility
`
`for sizes greater
`values
`is not a consideration.
`
`than those
`
`listed
`
`above are not specified: all instruments of greater size are
`
`5 Sampling
`
`A Sample of IO instruments
`
`shall be used of each type and size for validating the Fallowing Wuirements:
`
`a) dimensions
`
`(see 4.2);
`
`b) resistance
`
`to fracture
`
`in torque and angular deflection
`
`(see 4.3.1);
`
`c)
`
`resistance
`
`to bending
`
`(see 4.3.2).
`
`11
`
`17 of 28
`
`IPR2015-00632 - Ex. 1016
`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 36304
`
`:1992(E)
`
`in the test report.
`should be recorded
`The method of procurement
`If nine samples
`fails.
`If all IO samples pass, the product Passes.
`If eight or fewer samples pass, the product
`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
`
`in the respective
`
`test clauses.
`
`sampling
`
`is specified
`
`6 Testing
`
`6.1 Visual
`
`inspection
`
`For compliance with the requirements,
`
`visually
`
`inspect at normal visual acuity (unless otherwise
`
`specified).
`
`62 .
`
`Measurement
`
`of dimensions
`
`and tapers are measured or calculated with a shadowgraph
`lengths, diameters
`The
`equivalent accuracy,
`for example dial gauges.
`be-
`is the differente
`The taper
`is determined
`by calculation using actual measured diameters dz and d3. Taper
`tween dz and d3 divided by the length of the taper. Taper
`tolerante
`is controlled
`solely by the tolerante
`of the
`specified diameters.
`from the projection of the taper of the working part onto a plane at the tip of the
`The tip dimension
`is calculated
`is perpendicular
`to the
`long axis (centre-line)
`of that
`instrument. When deter-
`instrument
`(datum
`line) which
`mining
`the tip length,
`the intrument
`is turned until the edges on the tip show approximately
`the Same length.
`
`or other equipment
`
`of
`
`6.3 Resistance
`
`to fracture
`
`in torque
`
`and angular
`
`deflection
`
`6.3.1 Test apparatus
`
`(see figure 6).
`
`\
`
`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-‘.
`
`6.3.1.2 Torque-measuring
`
`device
`
`fixed on two linear ball-bearings mounted on the shaft of the device.
`
`12
`
`18 of 28
`
`IPR2015-00632 - Ex. 1016
`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.
`
`from soft brass
`Chuck, with jaws made
`6.3.1.3
`and coaxially with the torque axis (see figure 7).
`
`for clamping
`
`the test piece at the tip along a length of 3 mm
`
`ISO 36304:1992(E)
`
`T Chuck with steel jaws
`
`Soft brass
`
`jaws
`
`I
`
`Figure 7 - Test chuck detail
`
`and digital
`amplifier
`Separate
`6.3.1.4
`torque and angular deflection.
`
`display
`
`for controlling
`
`the Operation of the motor and recording
`
`the
`
`6.3.1.5
`
`Chuck with jaws made from hardened steel for clamping
`
`the test piece at the shank.
`
`6.3.2 Procedure
`
`to the instrument
`is attached
`the handle
`the handles with a suitable wire Cutter at the Point at which
`Remove
`shaft. 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 of the shank out of the
`chuck. Tighten
`the chuck.
`device along the linear bearing until the tip of the test piece enters 3 mm into
`Slowly slide the torque-measuring
`that the test piece
`is straight and centred
`into the jaws (see figure 6). Tighten
`the brass jaws. Check to ensure
`the chuck. Since clamping will probably
`induce a prestress of 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 test device
`will cease Operation when
`the test piece
`fails. Record
`the maximum
`torque and angular deflection
`for each
`piece tested.
`
`6.4 Resistance
`
`to bending
`
`6.4.1 Test apparatus
`
`jaws and the bending device
`of the clamping
`in 6.3.1 is used with the modification
`The equipment as described
`or catch pin as shown
`in figure 8. The amplifier
`shall be capable of being set to a pre-selected
`angular de-
`flection of 45’ at which Point the test Stops.
`
`6.4.2 Procedure
`
`the handles with a suitable wire Cutter at the Point at which
`
`the handle
`
`Remove
`shaft.
`to stop the angular deflection at 45”. Set the chuck onto the shaft of the torque-measuring
`Set the apparatus
`to the axis of the motor to a depth
`device. Set the tip of the test piece
`into the jaws of the chuck perpendicular
`of 3 mm. Tighten the chuck. Mount the catch pin onto the motor shaft. Slide the torque-measuring device along
`is located above the rotating pin. Rotate the motor in the correct di-
`the linear ball-bearing
`until the test piece
`the test piece. Ensure that the display Shows Zero. Acti-
`rection
`in stages until the catch pin is lightly
`touching
`vate the torque-measuring
`device. When
`the angular deflection has reached 45” the test will stop. Record
`the
`applied
`forte at the display
`for each piece tested.
`
`is attached
`
`to the instrument
`
`13
`
`19 of 28
`
`IPR2015-00632 - Ex. 1016
`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 36304:1992(E)
`
`Reversible
`
`gear motor
`
`\
`
`Torque-measuring
`
`device
`
`Figure 8 - Apparatus
`
`for bending
`
`test
`
`6.5 Resistance
`
`to pull and
`
`twist: handle or shank
`
`of each type and size, and test for pull strength:
`five instruments
`Take as a Sample
`ments of each type and size for twist strength.
`
`take another
`
`five instru-
`
`6.51 Pull strength
`
`to prevent axial
`the handle or shank
`end leaving 3 mm of the shaft exposed. Support
`the operative
`Grasp
`restriction
`to the embedded operative end. Apply a mass of 2,25 kg axially. Measure and
`movement without
`record
`the length of the operative end to determine any evidente of axial movement.
`
`Excluded are Paste carriers with a spiral between
`ture at