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है”ह”ह

IS 3387 (2004): Toothbrush [CHD 24: Brushware]

Indian Standard

TOOTHBRUSH — SPECIFICATION

( Second Revision)

Ics 97.170

0 BIS 2004

BUREAU OF INDIAN STANDARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

IS 3387:2004

August 2004 Price G-roup 4

Brushware Sectional Committee, CHD 24

FOREWORD

This Indian Standard ( Second Revision ) was adopted by the Bureau of Indian Standards, after the draftfinalized by the Brushware Sectional Committee had been approved by the Chemical Division Council.

A good toothbrush should provide not only efficient cleaning of the tooth surfaces but massaging of the gumsto some extent. A toothbrush may render both these functions if it is properly shaped and designed. Commonteeth and gum troubles may be due either to inadequate oral hygiene or maybe resu It of sub-standard quality oftoothbrush.

The standard was originally published in 1965. In the original standard toothbrushes were permitted to fillwith either bristles or nylon monofilament. Toothbrushes filled with bristles cause less tooth abrasion, toothneck defec-ts and gingival injuries. Both types of brushes show an insignificant difference in bacterial cultureafter brushing. Since the production of toothbrushes filled with bristles is meagre, first revision was taken upin 1973 to cover only toothbrushes filled with nylon monofilament.

Due to Jack of unanimity of dental profession regarding the ideal trim conducive to the satisfactory ultimateperformance of the toothbrush, the type of the trim has not been specified. But it was agreed that this aspectshould be specified in a more objective manner as and when more data is available.

With the experience of about last three decade and technical development in this area, the Committee decided torevise the standard for its updation and to bring it in line with other international standard. In this revision thescope of materials used in cleaning elements and handle’s material are widened based on the development withthe aim of betterment of the product. During this revision, instrumental method for quantizing pull strength fortuft and end rounding of tips of filaments are incorporated, requirements of number of filaments have been simplifiedand rationalized to give the opportunity to creative design.

There is no 1S0 standard on this subject. The standard has been prepared based on the indigenous technologyavailable in the country and assistance has been taken from JIS S 3016-1985 ‘Toothbrushes’.

The composition of the Committee responsible for formulation of this standard is given in Annex D.

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 accordance withIS 2: 1960 ‘Rules for rounding off numerical values ( revised )’. The number of significant places retained in therounded off value should be the same as that of the specified value in this standard.

IS 3387:2004

Indian Standard

TOOTHBRUSH — SPECIFICATION

( Second

1 SCOPE

This standard prescribes the materials, methods ofsampling and tests for toothbrushes manufacturedfor oral hygiene.

2 REFERENCES

The standards listed below contain provisions,which through reference in this text, constituteprovisions of this standard. At the time ofpublication, the editions indicated were valid. Allstandards are subject to revision, and parties toagreement based on this standard are encouragedto investigate the possibility of applying themost recent editions of the standards indicatedbelow:

IS No.

1843:1963

2267:1995

10951:1984

13193:1992

14434:1998

14753:1999

Title

Nylon monotilaments

Polystyrene moulding and extrusionmaterials — Specification

Polypropylene materials formoulding and extrusion ( first

revision )

Polyal kylene terephthalates( PET and PBT ) for moulding andextrusion

Polycarbonate moulding andextrison material — Specification

Polymethyl methacrylate( PMMA ) ( acrylic ) sheets

3 TERMINOLOGY

For the purpose of this standard, the following

Revision )

definitions shall apply:

3.1 Toothbrush — An implement comprising ofthe body and a head, designed to help in oralhygiene.

3.2 Head of Toothbrush — The part of toothbrushwhere cleaning elements are fastened.

3.3 “Brush Handle — The entire body of the brushincluding the head ( see Fig. 1 ).

3.4 Cleaning Elements — The protrusions fixedon the brush head, which is designed to impart thecleaning of the tooth surface, interproximal spacesand near gum line. It may consist of filaments,tufts made of filaments or specially designed elements( for example Iamella ) of synthetic materials.

3.5 Tuft — In case the cleaning element consists offilaments, the tuft is a bunch of filaments in eachhole in the head of toothbrush.

3.6 Trim Height — Total protrusion of cleaningelement from surface of the head of “brush.

3.7 End Rounding —The shape of the tips of thecleaning filament.

3.8 Pull Strength — The force required to pullout a cleaning element from head of toothbrush.

3.9 Anchor Wire — In case filaments are used ina cleaning element in a staple technology, theanchor wire is the wire which is used to fix a bunchof filaments ( that is a tuft ) in to the hole in headof toothbrush.

4 SIZES AND TYPES

4.1 Sizes

Toothbrushes shall be of the following sizes

Fw. 1 BRUSHHANDI.CWITHBRUSHHI. AI)

I

IS 3387:2004

depending on the

Variant

Adult

Junior

Baby

4.1.1 Toothbrush

length of handle:

Minimum Length of Handle

mm

I50

120

93

may or may not have the gumstimulator. The gum ‘stimulator, if present, shallbe made of high density polyethylene or thermoplastic elastomer or any such suitable flexiblematerial. It shall have a smooth small roundedtip. The top portion of gum stimulator shall beflexible and of medium hardness. It shall beattached firmly, preferably at the tail end oftoothbrush handle.

4.2 Types

Adult size of the toothbrush shall be of thefollowing types depending upon the gauge of thefilaments:

a) Super-soft,

b) Soft,

c) Medium, and

d) Hard.

5 REQUIREMENTS

5.1 Materials

5.1.1 Cleaning Element

5.1.1.1 Cleaning element shall consist of nylonfilaments — 6, 6; 6, 10; 6, 12, polyester filaments, polybutylene terphthalate filaments, thermoplasticelastomer, polyethylene filaments, polypropylenefilaments, or any combinations of above materials andshall be free from any disagreeable odour, taste andtoxic elements.

5.1.1.2 Cleaning elements may contain non-toxiccolours.

5.1.2 Filament

5.1.2.1 The filaments shall be in the form ofmonofilament, co-extruded filaments, hollowfilaments, filled filaments, or structured filaments.

5.1.2.2 The cross-section of the filaments shall beof circular, square, hexagonal, diamond, rectangular,or any other suitable shape.

5.1.2.3 The diameter of filaments used as fillingmaterial in a cleaning element in toothbrushes.shall be as given in Table 1. Tol-erance limit forindividual filament is &0.02 mm of claimed diameter

and average of fifty filaments shall fall in the rangespecified in Table 1.

Table 1 Diameter of Filaments

( Clause 5.1.2.3 )

sl Size Type Diameter of No. of Mono-No. Filaments filaments,

m m Min

(1) (2) (3) (4) (5)

O Adult Super-soft 0.12 s0.15 300

ii) Adult soft >0.15 <0.20 300

iii) Adult Medium >0.20 S 0.25 300

iv) Adult Ilard >0.25<0.35 300

v) .lunior Soft 0.15-– 0.20 250

vi) Baby soft ().12–0.18 250

5.1.3 Handle

It shall be manufactured from the following plasticmaterials and shall be free from disagreeable odourand test :

a)

b)

c)

d)

e)

o

@

h)

j)

k)

Polystyrene moulding powder ( see1S2267),

Polypropylene( Holmopolymer,Is 10951 ),

Cellulose acetatepowder,

moulding powderco-polymer ) ( see

propionate moulding

Styrene acrylonitrile ( SAN ),

Polyethylene terphthalate ( see IS 13193 ),

Polycarbonate ( see IS 14434),

Acrylonitrile butadiene styrene ( ABS ),

Methacrylate butadiene styrene ( MBS ),

Poly methyl methacrylate ( see 1S14753 ), and

Thermoplastic elastomer ( TPE ).

The manufacturer may choose to design his brushhandle from one or more polymers from above list.

5.1.4 Anch~r Wire

Anchor wire is generally used far toothbrushmanufactured by tufting/staple technology. Itshall consist of alum inium, brass, nickel-silver, or anyother suitable non-corrosive materials.

5.2 Manufacture

5.2.1 The manufacturer shall choose to design thecleaning elements in toothbrush head throughcombinations given in 5.1.1.

NOTE — Presently there are several designs oftoothbrushes of diffmmt sizes in the market havinga wide variation as regards to number of tufts perbrush, hole diameter and hence number of filaments

2

IS 3387:2004

per tuft. Moreover, toothbrushes based on novelcleaning elements ( such as Iamella ) made from novelmaterials have entered international and localmarkets. It is, therefore, not practical to lay downspecifications in these respect with a view toaccommodating all designs.

A good toothbrush should provide both efficientcleaning and gum massage to some extent and alldesigns should aim to deliver these benefits. Themanufacturer has his choice in design of the brushhead in terms of cleaning element design, number oftufts per brush, number of filaments per tuft andfilaments/cleaning element material to delivercleaning and gum massaging as long as he conformsto the stipulated guidelines.

5.2.2 Handle

The handles, either transparent or opaque, may bemanufactured in various colours and shades. The widthand thickness of the handle may vary according toindividual design, but the head shall be designed toallow for fixing of the cleaning element so as to meetthe stipulated pull strength requirement. The headshall not have any protruding parts.

5.2.3 Pigments for Handle Colours

Only food wrapper grade pigments certified withanalytical details by pigment manufacturer should beused for coloration of handles.

5.2.4 Head shape may be either rectangular,diamond, oval, round or any other shape to suitindividual design.

5.2.5 The maximum width of head of the toothbrushshall not be more than 13 mm for rectangular head,15.5 mm for diamond, round, oval and other shape incase of adult; 12 mm in case of junior and 9 mm incase of baby size.

5.2.6 The portion of the handle used for holding

may have elastomers such as TPE, rubber, combinationof rubber and other molding material or materialsmentioned in 4.2 for better grip and/or aesthetics.

5.2.7 The head andlor neck portion may havethermoplastic elastomer ( TPE ) for flexibility.

I 1 I 1

TARGET SHALLOW

5,2.8 The tail portion of the handle may or maynot have a hole circular or otherwise, to facilitatehygienic storage.

5.3 Tufting

5,3.1 Cleaning element should be fixed to brushhead using a suitable technology such as stapletechnology using an anchor wire, weldingtechnology, fusion technology, inmold weldingtechnology etc.

5.3.2 In case of toothbrushes in which anchor wireis used for fixing each cleaning element which is inthe form of a tuft, it shall be individually fixed in asuitable sized tuft hole on the brush head andsunk to the depth up to start of bottom cup of thehole (see Fig, 2).

5.3.3 The maximum protrusion of the cleaningelements from surface of head shall be 13 mm.

NOTE — Stiffness 01 cleaning material mainlydepends on the material used, cross-sectional areaand length. In case the filaments are used in thecleaning element, the stiffness of a tuft is mainlydependent on diameter of filament as well as trimheight. According to up to date findings of thedental profession the optimum protrusion of thefilling material shall be between 10 to 12. Longerlengths have the disadvantage of scattering and bendingout early, while protrusion of less than 7 mm isconsidered not desirable as per JIS S 3016-1985.

5.3.4 The tops of tufts may be trimmed to anyprofile to suit individual design but shall be in amanner, which does not injure the gums whilebrushing.

5.4 End Rounding

The heads of Imonofilalments shall be polished togive them round shape. The end rounding shallnot be less than 50 percent when determinedaccording to the method given in Annex A.

5.5 Pull Strength

The force required for pulling out an individualtuft shall not be less than 1.0 kg when testedaccording to the method given in Annex B.

ANCHOR WIRE

DEEP

FIG. 2 USE OFANCHORWJ~~IN TUI~IIN(i

3

1S 3387:2004

6 MARKING 7 PACKING

6.1 Unless otherwise agreed to between thepurchaser and the supplier, each brush shall belegibly and indelibly marked or stamped withmanufacturer’s name or recognized trade-mark, ifany, and the type of brush.

6.1.1 BIS Certification Marking

Toothbrushes may also be marked with the StandardMark.

6.1.1.1 The use of the Standard Mark is governedby the provisions of Bureau of Indian Standards

Act, 1986 and the Rules and Regulations made

thereunder. The details of conditions under whichthe licence for the use of the Standard Mark may begranted to manufacturers or producers may beobtained from the Bureau of Indian Standards.

7.1 The toothbrushes shall be packedindividually in suitable containers to protect themhygienically from external elements.

NOTE — Typical containers are paperboard or PVCblister or combination ot PVC-PVC/ PVC-paperboardcombination, polyethylene pouch, Plastic containers,BOPP or any other suitable container.

7.2 These individually packed brushes shall bepacked further as per mutual agreement betweenthe purchaser and the supplier to facilitatetransport, storage and display.

8 SAMPLING

Representative samples for test shall be drawn asprescribed in Annex C.

.

4

_-

1S3387:2004

ANNEX A

( Clause 5.4)

DETERMINATION OF END ROUNDING

A-1 GENERAL

Although this test is subjective in the beginning,one can determine end rounding fairly accuratelyand results can be reproducible.

A-2 APPARATUS

Simple or compound microscope ( advisable ) withadequate magnification to observe the end roundingof filament tips

A-3 PROCEDURE

Select three tufts in a toothbrush — middle tuftof second horizontal row from top of toothbrushhead and two middle tufts of second horizontalrow from bottom of toothbrush head — to ensuremaximum area coverage.

A-3.1 Count number of tips ofmonofilaments in eachselected tufts — El, El, Es.

number of tips of monofilament in firsttuff,

number of tips of monofilament in secondtuff, and

number of tips of monofilament in thirdtuff.

A-3.2 Strand Count = El or Ez or EJ2

A-3.3 Observe the end rounding of the tips ofmonofilament from each selected tufts undermicroscope and count the number of tips withacceptable end rounding. The tips of monofilamentwith any sort of sharp angle slcorners or edgesshall be unacceptable and those without any suchsharp angles/corners or edges shall be acceptable( see Fig. 2 ). Note down the findings — OKI, OKZ,

OK3.

where

OKI = number of tips of acceptablemonofilament in first tuff,

OKZ = number of tips of acceptablemonofilament in second tuff, and

0K3 = number of tips of acceptablemonofilament in third tuff.

A-3.4 Calculation

End-rounding, percent =(OK[+OK1+OK3) X)00

EI+EZ+E3

A-3.5 Repeat the same procedure for two moretoothbrushes from a lot.

A-3.6 Take average of end-rounding of threetoothbrushes.

ACCEPTABLE

nnnII

END ROUNDINGNOT ACCEPTABLE

IDEAL

n

n(Tn’

FIG. 3 GUIDELINESFORACCEPTABLEANDUNACCEPTABLEEND ROUNDING

5

1S 3387:2004

ANNEX B

( clause 5.5 )

DETERMINATION OF PULL STRENGTH

B-1 APPARATUS

A simple instrument as shown in Fig. 4 can beused for testing the pull strength. This unit issuitable for mounting on wall. It consists of dialforce gauge/weighing scale operating on spring(B)mounted on wooden plate (,4 ). A tubular tuft-holder( C ) is hung on the hook of dial gauge. A clamp forholding toothbrush ( E ) is provided which is movabledownward and upward with a screw(G).

NOTE — Manufacturer may use sophisticated electronicinstrument available in market to determine tbe pullstrength.

B-2 PROCEDURE

B-2.1 Fix a toothbrush head with tufts in upward

direction in the toothbrush holder with the help ofscrew ( F).

B-2.2 Insert alIfilaments of one tuft in the hole providedat the bottom of tubular tuft-holder ( C). Care shouldbe taken not to allow filaments from adjacent tuft toenter in to the hole. Fix the tuft firmly withthe helpof screw ( D ).

B-2.3 Adjust the pointer on dial to zero by adjustment

of screw ( G).

B-2.4 Move down the toothbrush holder slowlywith screw ( G ) watching the pointer on dialcarefully. Note down the reading on dial at whichthe tuft comes out of the hole. This is the pullstrength of the tuft.

-WOODEN PLY (A)

— DIAL INDICATOR (B)

TUFT HOLDER (C)

SCREW (D)

TOOTHBRUSH HOLDER (E)

r-k \ i

‘f-:s-—SCREW (G)

ADJUSTMENT SCREW (F)

‘FIG. 4 INSTRUMENTFORDE.TE.RM1NATIONOFPULL STRENGTH

6

1S 3387:2004

ANNEX C

( Clause 8 )

SAMPLING AND CRITERIA FOR CONFORMITY

C-1 SAMPLING

C-1.l Lot

‘In any consignment all the toothbrushes of sametype, size, design and manufactured from the samematerials shall be grouped together to constitutea lot.

C-1.2 The conformity of the toothbrushes in a lot tothe requirements of this standard shall ascertainedfor each lot separately. The number of the toothbrushesto be selected for this purpose shall be in accordancewith CO11 and 2 of Table 2.

Table 2 Scale of Sampling

(-Clauses C-1.2 andC-1.3 )

SI No. of Toothbrushes No. of Toothbrushes“No. in the Lot to be Selected

(1) (2) (3)

O up to 50 2

ii) 51 to 100 5

iii) 101to 200 6

iv) 201 to 300 7

v) 301 to 500 8

vi) 501 and above 9

C-1.3 The toothbrushes shall be selected atrandom from the top, middle and bottom portion ofthe package. If the toothbrushes in a lot are packedin more than one package approximately equalnumber of brushes shall be selected at randomfrom as many packages as possible so as to obtainthe required number of toothbrushes for tests, asgiven in Table 2.

C-2 NUMBER OF TESTS

C-2.1 Test shall be conducted on the individual brushesin the sample.

C-3 CRITERIA FOR CONFORMITY

C-3.1 For declaring the conformity of the lot to therequirements of this standard, all the brushes selectedaccording to C-1.3 shall satisfy the relevantrequirements given in 4 and 5.

IS 3387:2004

ANNEX D

( Foreword)

COMMITTEE COMPOSITION

Brushware Sectional Committee, CHD 24

Orgcrrriution

A. B. Composite Private Limited, Kolkata

All India Plastic Manufacturers’ Association, Mumbai

A. K. Ghosal and Sons, Kolkata

Bhamt Heavy Electrical Limited, New Delhi

Brushweli and Co, Kolkata

Brush Exports Corporation, Ghaziabad

Central Brush Works, Kolkata

Colgate Palmolive ( India ) Limited, Mumbai

Department of Wild Life Preservation, New Delhi

Directorate General of Supplies and Disposal, New Delhi

Directorate of Marketing and Inspection, Faridabad

Directorate of Quality Assurance ( Naval ), Ministry ofDefence, New Delhi

Eastern Railway, Carriage and Wagon Workshop, Howrah

Forest Research Institute, Debra Dun

Hindustan Lever Limited, Mumbai

Indian Paints Association, Kolka(a

Indian Soaps and Toiletries Manufacturers Association,Mumbai

Ministry of Defence ( R & D ). DMSRDE, Kanpur

Ministry of Defence ( DGQA ), New Delhi

Ministry of Railways ( RDSO ). Lucknow

National Test House, Kolkata

Office of the Development Commissioner ( SS1 ). New Delhi

Rail India Technical and Economic Services, New Delhi

BIS Directorate General

R{,])re.scntalii’t’(.$)

SHkI ANLIKLII. SAMANTA ( Chairman )SHRI BASUIII;V SAMLNTA

SHRI DINESH KI;NIA

SHRI CHANoRAKAN”r GOI.A ( A/fernate )

SHRI R. K. GHOSAL

SHRI V. GH{MAI ( Alternate )

R]:riu:slm’rmvl:

SHIU JAYCHANIJRA MIiHTA

SHRI KITAN SHAH ( Alternate )

SHRI Mt)w,st! K. SHARMA

St[RIMm[ KIRAN -K\ IMARI ( Alternate )

SHRI A. K. SIKI)AR

Stml A. SIKIIA~ ( Alternate )

SH~I A. G. GAITONIII.

SHRI RISHI SItIvAs IAVA ( Alternate )

SHRI A. K. SIM,O

SHRI M. K. UIIAI)HAYA

St+l<[S. C, CHAIJHA ( Alfernafe )

D~ G. G(H)AI.A RA()

SHRI R. K. SI:HLiAI.

SHI{I K. K. SIN6HAI

SHKI AsHIs BANIXIIW

Dk C. N. PANOI;Y

( Alternate )

Dk V. K. JAIN ( A/rernafe )

SHRI N. S. BIII.ANI

SHRI VIIIiNDRA BI)ONIA ( A//ernate )

Stml K. D. SAWANT

SHKI MAI)AN THAKUR

SHRI RAVININR KUMAR

SHRI V. K. SIN{iH ( A/fernafe )

SHRI K. K, GHAI

SHRI RAM CFIANI)RA ( A/ternate )

SHRI B. B. HI, I)ALI

DR [. N. Muwiil<lli[i

SHRI P. S. SIKDAR ( Afrernare )

SHR1 P. DAS(IUI’TA

SHRI S, K. ROY ( Alternate )

SHRI J. S. AZAI)

SHRI V. K. JAIN ( A/fernafe )

SHRI S. K. CHAUI)HLIRI. Director and Head ( CHD )[ Representing Director General ( E.r-{/ffici{, ) J

Member Secretary

StIRI N, K. pAl

Director ( CHD ), BIS

8

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This Indian Standard has been developed from Doc : No. CHD 24 ( 1136 )

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

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