Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to information for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority, and whereas the attached publication of the Bureau of Indian Standards is of particular interest to the public, particularly disadvantaged communities and those engaged in the pursuit of education and knowledge, the attached public safety standard is made available to promote the timely dissemination of this information in an accurate manner to the public.

इंटरनेट मानक

“!ान $ एक न' भारत का +नम-ण”Satyanarayan Gangaram Pitroda

“Invent a New India Using Knowledge”

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“Step Out From the Old to the New”

“जान1 का अ+धकार, जी1 का अ+धकार”Mazdoor Kisan Shakti Sangathan

“The Right to Information, The Right to Live”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता है”Bhartṛhari—Nītiśatakam

“Knowledge is such a treasure which cannot be stolen”

“Invent a New India Using Knowledge”

है”ह”ह

IS 12624 (2005): Dental Root-Canal Obturating Points [MHD8: Dentistry]

IS 12624:2005ISO 6877:1995

( WFi’7jpi%wl)

Indian Standard

DENTAL ROOT-CANAL OBTURATING POINTS

( First Revision)

ICS 11.060.10

@ BIS 2005

BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

Jdy 2005 Price Group 5

.,,

Dentistry Sectional Committee, MGP 47

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 6877:1995 ‘Dental root-canal obturatingpoints’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau ofIndian Standards on the recommendations of the Dentistry Sectional Committee (MGP 47) and approvalof the Medical Instruments, General and Production Engineering Division Council.

This standard was first published in 1989 and was based on lSO/DIS 6877 ‘Dental root-canal obturatingpoints’. Its first revision has been undertaken to align it with ISO 6877 brought out in 1995.

Specific qualitative and quantitative requirements for freedom from biological hazards are not includedin this standard, but it recommended that, in assessing possible biological or toxicological hazards,reference should be made IS 12572 (Part 10): 1988 ‘Guide for evaluation of medical devices for biologicalhazards: Part 10 Methods of biological testing and evaluation of dental materials’.

Manufacturers wishing to declare conformity with this standard should refer to lSO/lEC Guide 22‘1nformation on manufacturer’s declaration of conformity with standards or other technical specifications’.

The text of the ISO Standard has been approved as suitable for publication as an Indian Standardwithout deviations. Certain conventions are, however, not identical to those used in Indian Standards.Attention is particularly drawn to the following:

a) “Wherever the words ‘International Standard’ appear referring to this standard, they shouldbe read as”’lndian Standard’.

b) Comma (,) has been used as a decimal marker in the International Standard while in IndianStandards, the current practice is to use a point (.) as the decimal marker.

In this adopted standard, reference appears to the following International Standard for which IndianStandard also exists. The corresponding Indian Standard which is to be substituted in its place is listedbelow along with its degree of equivalence for the edition indicated:

International Standard Corresponding Indian Standard Degree ofEquivalence

ISO 209-1:1989 Wrought IS 504 (Parts 13 to 16) :2003 Chemical Technicallyaluminium and aluminium alloys analysis of aluminium and its alloys (second equivalent— Chemical composition and revision)

form of products — Part 1:Chemical composition

The Technical Committee responsible for the preparation of this standard has reviewed the provisions ofthe following International Standard and has decided that the same is acceptable for use in conjunctionwith this standard:

International Standard Title

ISO 3665:1996 Photography — Intra-aral dental radiographic film — Specification

For the purpose of deciding whether a particular requirement of this standard is complied with, the finalvalue, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordancewith IS 2 :1960 ‘Rules for rounding off numerical values (revised)’. The number of significant placesretained in the rounded off value should be the same as that of the specified value in this standard.

.,.

IS 12624:2005ISO 6877:1995

1 -Scope

Indian Standard

DENTAL ROOT-CANAL OBTURATING POINTS

( First Revision)

This International Standard specifies the dimensionsand compositional requirements for prefabricatedmetallic or polymeric-based points or cones suitablefor use in the obturation of the dental root-canal, butnot for support of a coronal restoration. It alsospecifies numerical systems and a colour codingsystem for designating the sizes.

In addition to the requirements for the product itself,this International Standard also contains informationabout packaging the product. Although this infor-mation is important, it is not included as part of therequirements because no test methods are available(see annex A).

Dental root-canal obturating points are marketedsterilized or unsterilized. This International Standardcovers the physical attributes expected of suchproducts as supplied. Requirements for sterility arenot included, and any claim that the product is sterileis the responsibility of the manufacturer (see clauseA.2).

2 Normative references

The following standards contain provisions which,through reference in this text, constitute provisions ofthis International Standard. At the time of publication,the editions indicated were valid. All standards aresubject to revision, and parties to agreements basedon this International Standard are encouraged toinvestigate the possibility of applying the most recenteditions of the standards indicated below. Membersof IEC and ISO maintain registers of currently validInternational Standards.

ISO 208-1:1989, Wrought aluminium and aluminiumalloys — Chemical composition and form of products— ,Pafl 7,.chemica/ composition,

ISO 3665:1976, Photography — Intra-oral dental radio-graphic film — Specification.

3 Definitions

For the purposes of this International Standard, thefollowing definitions apply.

3.1 point Complete prefabricated metallic orpolymeric dental rmt-canal obturating point.

3.2 end Broad end of the point.

3.3 tip: Narrow end of the point.

3.4 unit pack Smallest pack of points distributed,containing one or more sizes of point.

3.5 standardized points Points having uniformstandardized tapers throughout all the ranges of sizesavailable.

3.6 -taper-sized points: Points whose sizes aredetermined by the tip sizes and the tapers.

4 Requirements

4.1 Materials

4,1.1 Metal points

Throughout their tapeced length, the pointssmooth, uniform in composition, withoutpitting and free from inclusions or extraneous

shall besurface

matter.

Testing shall be carried out in accordance with 6.2.

1

IS 12624:2005

-,,

ISO 6877:1995

4.1.2 Poiymeri~baaad points

Throughout their tapered length, the points shallappear uniform in composition and colour, smooth,with an untracked surface and free from inclusionsand extraneous matter.

Testing shall be carried out in accordance with 6.2.

4.2 Biocompatibility

See the Introduction for guidance on biocompatibility.

4.3 Length

Unless otherwise stated by the manufacturer, theoverall length shall be not less than 28 mm. If someother length is stated, the points shall be within~ 2 mm of the stated length.

To check this, choose ten samples at random. If allten samples pass the requirement, the productpasses. If eight or fewer samples pass, the productfails. If nine samples pass, test five additionalsamples. When the five additional samples are testedall five shall comply for the product to pass.

Testing shall be carried out in accordance with 6.3.

4.4 Size designation and taper

The designation is a numerical indication of theprojected tip diameter, measured in millimetres.

4.4.1 Standardizedpoints

The size designation of standardized points shall be inaccordance with the numbering’ system shown intable 1.

Samples tested shall meet the requirements oftable 1.Choose ten samples at random. If all ten samplespass the requirement, the product passes. If eight orfewer samples pass, the product fails. If nine samplespass, test five additional samples. When fiveadditional samples are tested all five shall comply forthe product to pass.

The taper of the points shall be uniform for aminimum of 16 mm from the tip as illustrated infi9Ure 1 and as shown in table 1.

A tolerance of + 0,02 mm for metallic points,~ 0,05 mm for polymeric points of sizes 010 to 025and 0,07 mm for polymeric points of sizes 030 to 140is permissible.

Testing shall be carried out in accordance with 6,4.

Table 1— Size designationfor standardizedpoints

Dimensions in millimetres

Size Diameter Diametar Diametardesignation dl ref. d2 d3

010 0,10 0,16 0,42

015 0;15 0,21 0,47

020 0,20 0,26 0,52

.025 0,25 0,31 0,57

030 0,30 0,36 0,62

035 0,35 0,41 0,67

040 0,40 0.46 0,72

045 0,45 0,51 0,77

050 0,50 0,56 0,82

055 0,55 0,61 0,87

060 0,60 0,66 0,92

070 0,70 0,76 1,02

080 0,80 0,86 1,12

090 0,90 0,96 1,22

100 1,00 1,06 1,32

110 1,10 1,16 1,42

120 1,20 1,26 1,52

130 1,30 1,36 1,62

140 1,40 1,46 1,72

2

.,,,

IS 12624:20051s0 68?7 :1995

Dimensions in millimetres

Optional flattened end7

x \$ (K) ——.

3

’16

Overall Length

xt--

Datumline

L projected ~iame+erat lip

NOTES

1 The diameters are expressed in hundredths of a millimetre. Table 1 gives the values of d,, d2 and d~for each size.

2 The taper is 0,02 mm per 1 mm, length, therefore, d3 = d, + 0,32 mm.

3 In detail X, the exact shape of the tip is left to the option of the manufacturer.

Figure1— Diagrammaticrepresentationof standardizedpoints

4.4.2 Taper-sizedpoints

The size designation of taper points shall be inaccordance with the system shown in figure 2.

NOTE 1 The first three numbers of the system representthe projected tip diameter measured in hundredths ofmillimetres. The last two numbers indicate the taper.

Not less than eight out of ten measurements of eachdiameter of the ten samples tested shall meet therequirements of figure 2.

The taper of the points may vary with the size but thetaper shall be uniform for at least the first 16 mm

measured from the tip, or throughout its completelength if shorter than 16 mm.

Testing shall be carried out in accordance with 6.4.

4.5 Brittleneaa

None of the five samples tested (see 6.5) shall showany sign of fracture.

Testirrg shall be carried out in accordance with 6.5.

3

IS 12624:2005ISO 6877:1995

-,,

160

lLO

120

100

c.9:

“: 80Gw.EU?

60

40

20

0

NOTES

Diameter I-I,,mm

0,1 0,2 0,3 0,4 0,5 0,6 0,7 0,8- —

0,9

::::::

Y,..:....::,-+

1,;1,1,;11,

1 + .1,1,;1,111

:-; -l

1,;1,1,!

/ +_.11II1[II

-’P-;-1111IIII

;+

111!1!II

;-{-

111!II,,

Dimensions in millimetres

1 1,1 1,2 1,3 1,4 1,5:: ::: ::: :::: :::: :::::: :::: :::;:; :::: :::.::::

::::::::::::

1,

1,

1,1! ;;11;1 ;;,1,11,111 ,,1,11, ;11;1 ,;,1,1!,

.;++:-l”+++;-;-+ --

I!ll;!l, ;ll :1; I111,111 ,;,l;[:l; :;; l, ,11,

11, 1! 11!

0,04 0,05 0,06 0,07 0,08 0,09 0,99

Taper ratio mmTaper/mm Length

9 max.

o

10

10

c0.-

;0 z.5m+3

;0 ~t?

Lo

30

20

10

0

1 d, is the projected diameter at the tip and the designation is a threedigit number in hundredths of millimetres

2 The taper is given by the manufacturer and the designation is a two-digit number in thousands ofmillimetres.

3 A tolerance of t 0,02 mm for metallic points and+ 0,05 mm for polymeric-based points applies to all calculated diameters.

4 The designation form is a fiw+digit numbec “OOOXX” where “000” represents tip diameter (d,) and “XX” represents taper.

5 To determine diameters to test taper

d2 = d, + 3 x taper

d3=d1 + 16x taper

Example d, = 0,22

taper = 0,037

taper size = 02237

figure 2 — Identificationand dimensions of obturatingpoint tapersize

4

IS 12624: 2“605

ISO 6877:1995

4.6 Radiopacity

The material from which polymeric points are madeshall have a radiopacity equivalent to 6-mm thickaluminium.

Testing shall be carried out in accordance with 6.6.

4.7 Colour coding

The use of colour coding on the packaging or theindividual points to indicate the nominal sizedesignation is optional; if used Ihe colours shall

conform with table 2.

Table2 — Colour code for size designation

Sizedesignation Colour code Abbreviation

010 purple pur015 white wh020 yellow yel025 red red030 blue blu035 ‘green grn J

040 black blk

045 white wh

050 yellow yel

055 red red

060 blue blu

070 green grn

080 black blk

090 white wh

100 yellow yel

110 red red

120 blue blu

130 green grn

140 black blk

5 Procurementof samples

Samples for testing for compliance with this inter-national Standard shall be procured on the openmarket. Sufficient numbers shall be obtained so thatall tests can be carried out on at least five sizes ofpoints from each manufacturer, or the maximumnumbers of sizes manufactured if less than five.

6 Test methods

6.1 Test condtiions

Conduct all tests athumidity of (50 15) %.

23 “C* 2 ‘C and a relativeCondition the points at this

temperature and humidity for 24 h prior to testing.

6.2 Visual examination

Examine under a bright light at normal visual acuity.

6.3 Length

Test ten specimens selected at random.

Place the point on a scale rule marked in 0,5 mmgraduations and measure the overall length to thenearest 0,5 mm.

6.4 Size designation

6.4.1 Equipment

Use a shadowgraph or other suitable non-com-pression testing apparatus calibrated to an accuracyof 0,001 mm.

6.4.2 Mathod

Visually examine the shadow cast by the point andconfirm that at least the first 16 mm is evenlytapered. Measure and record the diameter of the tenpoints at distances 3 mm (d2) and 16 mm (d~) from thetip.

6.4.3 Calculation

Calculate the taper of taper points using the systemshown in figure 3. Determine the size designationusing the system shown in figure 2.

5

IS 12624:2005

IS(3 6877:1995

Optionalflattened end

\

-,,

xB“ (-a ) —.s.

L.

Lb -1Overall Length

x

-1==Datumline

:

~ Projected diameter at tip

NOTES

1 See table 1 for diameters d,, for each nominal size

2 The taper, T, varies according to the size and is calculated from the equation

== b-a

Lb – La

where

a is the diameter at La

b is the diameter at Lb

3 Detail X is as in figure 1.

Figure 3 — Diagrammatic representation of taper calculation for taper points

6.5 Brittleness

6.5.1 Apparatus

A suitable apparatus is shown in figure 4.

6.5.2 Procedure

Test five samples using the apparatus in figure 4 orsimilar apparatus. Grip the first five millimetres of thetip of a point in the stationary pin vice (D) taking care

6

to minimize damage to the point. Adjust the point sothat the junction of the point and the pin vice (D) is atthe centre of the rotation (F). Clamps the free end ofthe point in the movable pin vice (E) -so that thedistance between the junctions at the point with thepin vices (D) and (E) is 14 mm. Take 0° as the startingpoint of the test. Rotate the disc (A) anticlockwisethrough 30°, then clockwise through 60° and finallyreturn anticlockwise to the starting point of the test.Complete the bending cycle in approximately 2 s.Repeat the bending cycle four times for metallicpoints and 20 times for polymeric points: reportwhether any of the five points fractured.

-.

IS 12624:2005ISO 6877:1995

I I

H

IE

,B

D /

c

1’

1

I

Movable pin vice with vertical adjustment

Centre of rotation

Suspension point for pin vice E

Handle for disc rotation

30”

_ _.— .—. — .—. — .,

A

f I

1

I

KeyA Rotating disc E

B Bearing support for disc A F

C Stationa~ pin vice support with lock G

D Stationary pin vice H

Figure4 — Apparatus for testing br-mleness

.6.6 Radiopac”@

6.6.1 Apparatus

6.6.1.1 Stainless steel ring mould, with an internaldiameter of 10 mm and a height of 1 mm with coversmade of plastics film.or other radiolucent material.

6.6.1.2 Single phase dental X-ray unit, with totalfiltration of 1,5 mm of aluminium, capable of operationat 65 kV f 5 kV with suitable accessories.

6.6.1:3 Dental X-ray occlusal film, complying with

ISO 3665, developing-solution and fixer.

6.6.1.4 Aluminium step wedge, of 50 mmx 20 mm, having a thickness range of 1 mm to

10 mm in steps of 1 mm or a-small aluminium plate of6 mm thickness. Both shall be made from aluminiummetal designated Al 99 Cu in accordance with table 1in ISO 209-1:1989.

NOTE 2 This grade is also designated 1100 by theRegistration Record of International Alloy Designationsand Chemical Composition Limits for Wrought AluminiumAlloys published by the Aluminium Association,Washington D.C., USA.

6.6.1.5 Photographic densitometer.

6.6.2 Procedure

Take sufficient points of each size and soften, mix andcompress them into the ring mould to make a disc of

7

IS 12624:2005ISO 6877:1995

2 mm uniform thickness. Position the specimen in thecentre of the X-ray film adjacent to the aluminiumstep wedge or plate.

Irradiate the specimen, aluminium step wedge orplate and film with X-rays at a target film distance of300 mm for such a time that, after processing, theregion of the film beside the specimen and standardhas a photographic density between 1,5 and 2,0.

After processing and drying the film, compare thedensity of the image of the specimen with that of thealuminium standard using the densitometer. Ensurethat measurements with the densitometer are madein the lightest area of the image.

NOTE 3 Voids or thin areas in the sample preparation aredifficult to avoid and will be obvious in the developedradiographic film.

6.6.3 Interpretation of the results

Compare the density of the specimens with thedensity of the images of either the step wedge or thealuminium plate. In order to pass the test, the resultsof all three determinations shall meet the requirementin 4.6.

7 Informationto be suppliedbymanufacturer

The manufacturer shall provide at least the followinginformation on, or with, each unit pack:

a)

b)

c)

d)

e)

f)

g)

h)

i)

the identification of the material and the product,e.g. gutta-percha root-canal obturating point;

the manufacturer’s and/or supplier’s name orregistered trademark;

the size designation (see 4.4);

the minimum number of points in the unit pack;

the nominal length of the points;

the word “STERILE”, if the manufacturer claims(see A.2) that the contents of e unopened pack

4are sterile. In addition, on . packs of pointsmarked “STERILE”, a statement to the effect thatsterility is not guaranteed after the pack isopened;

the date of packaging and/or the batch number;

the recommended storage conditions;

an indication of the principal components.

8

.,,

IS 12624:2005ISO 6877:1995

Annex A(informative)

Recommendations to manufacturers

Ail Packaging

Points should be packaged in unit packs that protect

the contents from damage and, where sterility isclaimed (see A.2), maintain sterility during handling.Unit packs containing more than one size’ of pointshould not permit the various sizes to be readily orunknowingly mixed.

A.2 Sterility

A claim by the manufacturer that the contents of theunopened pack are sterile is the responsibility of the

manufacturer. This International Standard does notspecify requirements or test methods for sterility;reference should be made to any national require-ments that may exist. When no national requirementsexist, reference should be made to the United StatesPharmacopoeia (USP) or the .British Pharmacopoeia(BP).

NOTE 4 Standards on methods of validating sterilizationprocesses are in preparation by lSO/lC 194, B;o/ogica/evaluation of medical devices. .

9

IS 12624:2005

ISO 6877:1995

Annex B(informative)

Bibliography

[1] ISO 3630-1:1992, Dental root-canal instruments — Part 1: Files, reamers, barbed broaches, rasps, pastecarriers, expiorers and cotton broaches.

[21 lSO/TR 7405:1984, Biological evaluation of dental materials.

[31 Guide 22 lSO/CEl, Information on manufacturer’s declaration of conformity with standards or other technicalspecifications.

10

.,“

Bureau of Indian Standards

BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promote

harmonious development of the activities of standardization, marking and quality certification of

goods and attending to connected matters in the country.

Copyright

BIS has the copyright of all its publications. No part of these publications may be reproduced in any

form without the prior permission in writing of BIS. This does not preclude the free use, in the course

of implementing the standard, of necessary details, such as symbols and sizes, type or grade

designations. Enquiries relating to copyright be addressed to the Director (Publications), BIS.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are

also reviewed periodically; a standard +dong with amendments is reaffirmed when such review indicates

that no changes are needed; if the review indicates that changes are needed, it”is taken up for revision.

Users of Indian Standards should ascertain that they are in possession of the latest amendments or

edition by referring to the latest issue of ‘BIS Catalo.gue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed from Dot: No. MGP 47 (0498).

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

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