©ISO 2004- All rights reserved
`
`ISO TC 106/SC 4 N
`
`Date: 2004-02-03
`
`ISO/CD 3630-1
`
`ISO TC 106/SC 4/WG 9
`
`Secretariat: DIN
`
`ISO/TC 1 06/SC 4/WG 9
`N 143
`2004-06-30
`
`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 provide supporting documentation.
`
`International Standard
`Document type:
`Document subtype:
`(30) Committee
`Document stage:
`Document language: E
`
`GOLD STANDARD EXHIBIT 2027
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`G:\KEL\IS0\1 06\SC4\WG09\3630-1 \CD3630-1 \IS0_3630-1_(E).doc STD Version 2.1 c
`
`

`
`ISO/CD 3630-1
`
`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
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`
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`
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`
`Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.
`
`Violators may be prosecuted.
`
`©ISO 2004- All rights reserved
`
`

`
`ISO/CD 3630-1
`
`Contents
`
`Page
`
`Foreword ............................................................................................................................................................. v
`
`Introduction ....................................................................................................................................................... vi
`
`Scope ..................................................................................................................................................... 1
`
`Normative references ........................................................................................................................... 1
`
`Terms, definitions and symbols .......................................................................................................... 2
`Terms and definitions ........................................................................................................................... 2
`Symbols ................................................................................................................................................. 3
`
`Classification ......................................................................................................................................... 3
`
`2
`
`3
`3.1
`3.2
`
`4
`
`Requirements ........................................................................................................................................ 4
`5
`General ................................................................................................................................................... 4
`5.1
`Standard sized instruments (Type 1 instruments) ............................................................................ 4
`5.2
`Length .................................................................................................................................................... 4
`5.2.1
`5.2.2 Size designation and diameters .......................................................................................................... 4
`5.2.3 Colour designation ............................................................................................................................... 4
`5.2.4 Tip shape ............................................................................................................................................... 5
`5.2.5 Tip length and taper .............................................................................................................................. 5
`5.2.6 Handle or shank .................................................................................................................................... 5
`5.3
`Taper-sized instruments (Type 2 instruments) .................................................................................. 6
`5.3.1
`Length .................................................................................................................................................... 6
`5.3.2 Size designation .................................................................................................................................... 6
`5.3.3 Diameter identification ......................................................................................................................... 6
`5.3.4 Taper identification ............................................................................................................................... 6
`5.3.5 Diameter colour identification ............................................................................................................. 6
`5.3.6 Taper colour identification ................................................................................................................... 6
`5.3.7 Ring of mark identification ................................................................................................................... 6
`Shape-sized instruments (Type 3) ...................................................................................................... 6
`5.4
`5.4.1
`Length .................................................................................................................................................... 6
`5.4.2 Size designation and diameters .......................................................................................................... 7
`5.4.3 Colour designation ............................................................................................................................... 7
`5.5
`Non-tapered sized instruments (Type 4) ............................................................................................ 7
`5.5.1
`Length .................................................................................................................................................... 7
`5.5.2 Size designation and diameters .......................................................................................................... 7
`5.5.3 Colour designation ............................................................................................................................... 7
`5.6
`Material .................................................................................................................................................. 7
`5.6.1
`Instrument ............................................................................................................................................. 7
`5. 7
`Dimensions ............................................................................................................................................ 7
`5.7.1 General ................................................................................................................................................... 7
`5. 7.2
`Length .................................................................................................................................................... 8
`5.7.3 Shank ..................................................................................................................................................... 8
`5.8
`Mechanical requirements ..................................................................................................................... 9
`5.8.1 Resistance to fracture by twisting ...................................................................................................... 9
`5.8.2 Resistance to bending .......................................................................................................................... 9
`5.8.3 Stiffness ............................................................................................................................................... 1 0
`5.9
`Chemical requirements ...................................................................................................................... 10
`5.9.1 Resistance to corrosion ..................................................................................................................... 10
`5.9.2 Heat effects of sterilization ................................................................................................................ 10
`
`6
`
`7
`
`Sampling .............................................................................................................................................. 10
`
`Testing ................................................................................................................................................. 10
`
`© ISO 2004 -All rights reseNed
`
`iii
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`

`
`ISO/CD 3630-1
`
`Visual inspection ................................................................................................................................. 10
`7.1
`Test conditions .................................................................................................................................... 11
`7.2
`Measurement of dimensions .............................................................................................................. 11
`7.3
`Resistance to fracture by twisting and angular deflection ............................................................. 11
`7.4
`Test apparatus ..................................................................................................................................... 11
`7 .4.1
`7.4.2 Procedure ............................................................................................................................................. 12
`7.5
`Stiffness ............................................................................................................................................... 13
`7.5.1
`Test apparatus ..................................................................................................................................... 13
`7 .5.2 Procedure ............................................................................................................................................. 13
`7.6
`Handle and shank security ................................................................................................................. 13
`7.6.1
`Pull strength ........................................................................................................................................ 13
`7.6.2
`Twist strength ...................................................................................................................................... 14
`7.7
`Corrosion tests .................................................................................................................................... 14
`
`8
`8.1
`8.2
`
`9
`
`10
`
`Designation, marking and identification ........................................................................................... 15
`General ................................................................................................................................................. 15
`Identification symbols ........................................................................................................................ 15
`
`Packaging ............................................................................................................................................ 15
`
`Labelling ............................................................................................................................................... 15
`
`Bibliography ..................................................................................................................................................... 17
`
`Figures
`
`Figure 1 -Files, type H; files, type K, reamers, type K ...................................................................................... 5
`
`Figure 2 -Typical instrument shapes - Dimensions, locations .......................................................................... 4
`
`Figure 3 -Apparatus for torque test.. ............................................................................................................... 12
`
`Figure 4 - Details of test chuck ........................................................................................................................ 12
`
`Figure 5 -Apparatus for bending test .............................................................................................................. 13
`
`Figure 6- Identification symbols for root-canal instruments ............................................................................ 15
`
`Tables
`
`Table 1 -Standard-sized dimensions, size designation, and colour designation .............................................. 9
`
`iv
`
`©ISO 2004- All rights reserved
`
`

`
`ISO/CD 3630-1
`
`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
`
`Part 4: Shaping and cleaning instruments
`
`Part 5: Auxilliary instruments
`
`© ISO 2004 - All rights reserved
`
`v
`
`

`
`ISO/CD 3630-1
`
`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, Cleaning and Shaping instruments, and
`Accessories. 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 document does not attempt to provide
`information for proper use of any instruments.
`
`The sizes of the obturating points (cones) specified in ISO 6877 [1] have to be aligned with the corresponding
`sizes for root-canal instruments specified in ISO 3630.
`
`vi
`
`© I SO 2004 - All rights reserved
`
`

`
`COMMITTEE DRAFT
`
`ISO/CD 3630-1
`
`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
`instruments, condensers, and accessory
`endodontic purposes, e g. enlargers, cleaning and shaping
`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 1797-1:1 992, 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
`
`I SO 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 2004- All rights reserved
`
`1
`
`

`
`ISO/CD 3630-1
`
`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 by the dentist for the mechanical preparation of root canals for treatment. 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
`taper-sized instrument
`root-canal instrument whose sizes are determined by the tip sizes and have tapers other than 0,02 mm per
`millimetre of length
`
`3.1.4
`shape-sized instrument
`root-canal instrumentshaving a contoured working part with continuously varying profile
`
`3.1.5
`non-tapered sized instrument
`root-canal instrument having a cylindrical form along the long axis
`
`3.1.6
`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
`
`3.1.7
`standard sized instrument
`root-canal instrument whose sizes are determined by the tip sizes and have tapers other than 0,02 mm per
`millimetre of length
`
`3.1.8
`guided tip instrument
`root-canal instrument having a tip which guides access within a root canal
`
`3.1.9
`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
`
`3.1.10
`working part
`portion of the root-canal instrument with an active cutting surface
`
`3.1.11
`shank
`part of the root-canal instrument to be connected into a handpiece
`
`3.1.12
`handle
`part of the root-canal instrument to be manipulated by the user.
`
`2
`
`©ISO 2004- All rights reserved
`
`

`
`ISO/CD 3630-1
`
`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 12;
`
`d3 diameter at the end of minimum length of working part, length /3;
`
`11
`
`12
`
`13
`
`14
`
`15
`
`tip length;
`
`length for measuring point d2;
`
`length for measuring point d3; and minimum length of working part;
`
`length of operative part;
`
`length of neck.
`
`4 Classification
`
`For the purposes of this part of ISO 3630, dental root-canal instruments are classfied according to the shape
`and taper of the tip size (see Figure 1) as following:
`
`-Type 1: standard-sized instruments: taper :5 4 %;
`
`-Type 2. taper-sized instruments: taper> 4 %;
`
`-Type 3: shape-sized instruments: arc shape;
`
`-Type 4: non-tapered sized instruments: zero taper.
`
`Dimensions in millimetres
`
`16
`
`a) Type 1: standard sized instruments (taper :54%)
`
`© ISO 2004- All rights reserved
`
`3
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`

`
`ISO/CD 3630-1
`
`b) Type 2: taper-sized instruments (taper> 4 %)
`
`~--·-·-·B=--·-·-·-·-3-~ "i.l
`
`c) Type 3: shape-sized instruments (arc shape)
`
`d) Type 4: non-tapered sized instruments (zero taper)
`
`Figure 1 -Typical instrument shapes- Dimensions, locations
`
`5 Requirements
`
`5.1 General
`
`Specific instrument types, such as enlargers, have unique shapes which are not included here. These cases
`are covered in the separate part documents of the ISO 3630 series of standards.
`
`5.2 Standard sized instruments (Type 1 instruments)
`
`5.2.1 Length
`
`The length of the working part shall be a minimum of 16 mm The lengths of the working part and of the
`operative part shall be specified by the manufacturer, and shall be within 0,05 mm of the specified lengths. If
`the manufacturer specified the overall length, it shall be within 1,0 mm of the specified length.
`
`Testing shall be carried out in accordance with 7.3.
`
`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)
`dental root-canal instruments. Figure 1 shows the position of the diameters and lengths for all Type 1 dental
`root-canal instruments. The designation (code number) with three digits is part of the 15-digit identification
`number specified in ISO 6360-1 and ISO 6360-2. The nominal sizes shall correspond to the values of the
`extended diameters at the tip of the working part in hundredths of a millimetre.
`
`5.2.3 Colour designation
`
`Table 1 gives the colour designation for each size of Type 1 instruments. These colors are used for the
`identification of handle and shank. The provision of a handle or a shank is at the discretion of the
`manufacturer.
`
`4
`
`© ISO 2004- All rights reserved
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`
`ISO/CD 3630-1
`
`5.2.4 Tip shape
`
`The shape of the tip is at the discretion of the manufacturer.
`
`5.2.5 Tip length and taper
`
`The tip length shall be within the limits specified by the minimal and maximal angle (11 min to 11 ma0·
`
`Taper along working part shall be 0,02 mm per 1 mm of length.
`
`5.2.6 Handle or shank
`
`The provision of a handle or shank is at the discretion of the manufacturer.
`
`X
`
`Key
`
`handle
`
`The tip length shall be within the limits specified by the minimal and maximal angle (l1min to I1max).
`
`Taper along working part shall be 0,02 mm per 1 mm of length.
`
`Figure 2 - Files, type H; files, type K, reamers, type K
`
`© ISO 2004 -All rights reserved
`
`5
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`

`
`ISO/CD 3630-1
`
`5.3 Taper-sized instruments (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 0,05 mm of the specified lengths. If the manufacturer specified the overall length, it shall be within
`1,0 mm of the specified length.
`
`Testing shall be carried out in accordance with 7.3.
`
`5.3.2 Size designation
`
`The designated instrument size shall be presented as "xxx yy", where "xxx" is the diameter identification
`(5.2.2) and "yy" part is taper identification (5.2.3). 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.
`
`5.3.3 Diameter identification
`
`The diameter portion of the size designation shall be d1 (Figure 2) expressed.in hundreds of a millimetre.
`
`5.3.4 Taper identification
`
`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".
`
`5.3.5 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.
`
`5.3.6 Taper colour 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.
`
`5.3.7 Ring of mark identification
`
`When rings or other marks are included for a brand's set of taper sizes, number of rings or marks shall be in
`whole numbers sequence starting with one for the smallest percent taper.
`
`5.4 Shape-sized instruments (Type 3)
`
`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 0,05 mm of the specified lengths. If the manufacturer specified the overall length, it shall be within
`1 ,0 mm of the specified length.
`
`Testing shall be carried out in accordance with 7.3.
`
`6
`
`©ISO 2004- All rights reserved
`
`

`
`ISO/CD 3630-1
`
`5.4.2 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 of many possible shapes, the d1 is the diameter at the maximum diameter of the working
`part. The shape of the working part is left to the manufacturer.
`
`The arc-shape type shown in Figure 1 is an example of the maximum diameter.
`
`5.4.3 Colour designation
`
`When colour coding is used for Type 3 instruments, 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
`(except when up to three additional sizes are specified use purple, grey, and pink in descending order).
`
`5.5 Non-tapered sized instruments (Type 4)
`
`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 0,05 mm of the specified lengths. If the manufacturer specified the overall length, it shall be within
`1,0 mm of the specified length.
`
`Testing shall be carried out 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 1 is an example of the non-tapered diameter.
`
`5.5.3 Colour designation
`
`When colour coding is used for Type 4 instruments, the colour sequence is light to dark, i.e., white, yellow,
`red, blue, green, and black. This sequence is repeated for instruments with more than six sizes (except when
`up to three additional sizes are specified use purple, grey, and pink in descending order).
`
`5.6 Material
`
`5.6.1
`
`Instrument
`
`The operative part and the shaft, if of one part, 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 6.2 to 6.4 are fulfilled, the instruments are considered also to comply with the
`requirements of 6.1.2.
`
`5.7 Dimensions
`
`5.7.1 General
`
`The dimensions are given in millimetres.
`
`© ISO 2004- All rights reserved
`
`7
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`

`
`ISO/CD 3630-1
`
`The dimensions designated d and l shall comply with the requirements of the instruments' respective tables
`and figures. Variations in shape and design are permitted.
`
`Testing shall be carried out in accordance with 7.1, 7.2, and 7.3.
`
`5.7 .2 Length
`
`The length of the instrument shall be the nominal length as specified by the manufacturer with a tolerance of
`±0,5 mm.
`
`Testing shall be in accordance with 7.1, 7.2, and 7.3.
`
`5.7.3 Shank
`
`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 designed to be
`NOTE
`operated with hand pieces that are restricted to operate at slow speed unless otherwise specified.
`
`8
`
`©ISO 2004- All rights reserved
`
`

`
`ISO/CD 3630-1
`
`Table 1 -Standard-sized dimensions, size designation, and colour designation
`
`Nominal
`size
`
`006
`
`008
`
`010
`
`015
`
`o2o
`
`025
`
`030
`
`035
`
`040
`
`045
`
`d1
`
`ref.
`
`0,06
`
`0,08
`
`0,10
`
`0,15
`I 0,20
`0,25
`
`0,30
`
`0,35
`
`0,40
`
`0,45
`
`d2
`
`to I.
`
`d3
`
`to I.
`
`12
`
`min.
`
`13
`
`Colour
`designation
`
`012
`
`014
`
`016
`
`0,21
`
`0,26
`
`0,31
`
`0,36
`
`0,41
`
`0,46
`
`0,51
`
`± 0,02
`
`0,38
`
`0,40
`
`0,42
`
`0,47
`
`0,52
`
`0,57
`
`0,62
`
`0,67
`
`0,72
`
`0,77
`
`pink
`
`grey
`
`purple
`
`white
`
`yellow
`
`red
`
`blue
`
`green
`
`black
`
`white
`
`yellow
`
`± 0,02
`
`3
`
`16
`
`050
`
`055
`
`060
`
`070
`
`080
`
`090
`
`100
`
`110
`
`120
`
`130
`
`140
`
`0,50
`
`0,55
`
`0,60
`
`0,70
`
`0,80
`
`0,90
`
`1,00
`
`1,10
`
`1,20
`
`1,30
`
`1,40
`
`0,56
`
`0,61
`
`0,66
`
`0,76
`
`0,86
`
`0,96
`
`1,06
`
`1,16
`
`1,26
`
`1,36
`
`1,46
`
`± 0,04
`
`0,82
`
`0,87
`
`0,92
`
`1,02
`
`1,12
`
`1,22
`
`1,32
`
`1,42
`
`1,52
`
`1,62
`
`1,72
`
`± 0,04
`
`red
`
`blue
`
`green
`
`black
`
`white
`
`yellow
`
`red
`
`blue
`
`green
`
`black
`
`5.8 Mechanical requirements
`
`5.8.1 Resistance to fracture by twisting
`
`Instruments shall comply with the requirements specified in subsequent parts of ISO 3630.
`
`Testing shall be in accordance with 7.4.
`
`5.8.2 Resistance to bending
`
`Instruments shall comply with the requirements specified in subsequent parts of ISO 3630.
`
`Testing shall be in accordance with 7.5.
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`© ISO 2004- All rights reserved
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`9
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`ISO/CD 3630-1
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`5.8.3 Stiffness
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`5.8.3.1
`
`Handle and plastics 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.
`
`Testing shall be in accordance with 7.6.
`
`5.9 Chemical requirements
`
`5.9.1 Resistance to corrosion
`
`Instrument claimed to be corrosion resistant shall, upon visual inspection, show no evidence of corrosion.
`Testing shall be carried out in accordance with 7.7.
`
`5.9.2 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.
`
`Testing shall be carried out in accordance with 7.8.
`
`6 Sampling
`
`A sample of 10 instruments shall be used of each type and size for validating the following requirements:
`
`a) dimensions (see 5.2 to 5.6 and 5.8);
`
`b) materials (see 5.7);
`
`c)
`
`resistance to fracture by twisting (see 5.9.1);
`
`d)
`
`resistance to bending (see 5.9.2.2);
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`e) handle and shank security (see 5.9.2.2);
`
`f)
`
`chemical requirements (see 5.1 0).
`
`The method of procurement should be recorded in the test report.
`
`For other requirements sampling is specified in the respective test clauses.
`
`7 Testing
`
`7.1 Visual inspection
`
`Visual inspections shall be carried at normal visual acuity without magnification, unless otherwise specified.
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`10
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`© I SO 2004 - All rights reserved
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`

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`ISO/CD 3630-1
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`7.2 Test conditions
`Equipment and instruments shall be conditioned in accordance