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”

“प0रा1 को छोड न' 5 तरफ”Jawaharlal Nehru

“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 10654 (2002): Sterile Hypodermic Needles for Single Use[MHD 12: Hospital Equipment]

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IS 10654:2002ISO 7864:1993

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Indian Standard

STERILE HYPODERMIC NEEDLESFOR SINGLE USE( Third Revision)

ICS 11.040.20

(3 BIS 2002

BUREAU OF IN DIANST AN DARDSMANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG

NEW DELHI 110002

June 2002 Price Group 6

Medical Instruments and Disposable Sectional Committee, MHD 12

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NATIONAL FOREWORD : ‘t,

This Indian Standard (Third Revision) which is identical with ISO 7864 : 1993 ‘Sterile hypodermic \

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needles for single use’ issued by the International Organization for Standardization (ISO) was adopted,!,

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by the Bureau of Indian Standards on the recommendations of Medical instruments and Disposable t.

Sectional Committee and approval of Medical Equipment and Hospital Planning Division Council.!, ,

This standard was first published in 1983. Its first revision was undertaken in 1986 and published asdual number standard to align it with ISO 7864:1984. Second revision was undertaken in 1991 andpublished as dual number standard to align it with second edition of ISO 7864 brought out in 1988.Third revision of the standard adopts third edition of ISO 7864 brought out in 1993 and major differencesin third edition and second edition of ISO 7864 are as follows:

a) It specifies the use of needle tubing complying with ISO 9626. Smaller outside diameters, thinand extra-thin-walled types of needle tubing introduced. In order to avoid inhibiting innovation,this standard does not recommend combinations of needle diameter and length.

/b) Additional information and guidance have been introduced on needle point geometry and

fragmentation properties and the limited number of tests for toxicity has been replaced by aninformative annex.

c) It permits the use on package Iabelling of the ISO symbol for ‘do not re-use’, but continues torequire the written word. I

This standard covers sterile hypodermic needles intended for single use primarily in humans. [t doesnot give requirements or test methods for freedom from biological hazards because internationalagreement upon the methodology and the pass/fail criteria is incomplete. Guidance on biologicalevaluation and tests relevant to hypodermic needles are given in IS 12572 (Part 1) : 1994/ISO 10993-1 :1992 ‘Biological evaluation of medical devices: Part 1 Guidance on selection of tests(first revision)’ and it is suggested that manufacturers take this guidance into account when evaluatingproducts. Such an evaluation should include the effects of the process whereby the needles aresterilized. However, national regulations may exist in some countries, and these will override theguidance in IS 12572 (Part 1) : 1994/lSO 10993-1:1992,

!

Plastic materials to be used for the construction of needles are not specified as their selection will Idepend to some extent upon the design, process of manufacture and method of sterilization employedby individual manufacturers. The materials should be compatible with injection fluids.

Where Indian Pharmacopoeia or other government regulations are legally binding, these requirementsmay take precedence over this Indian Standard. ,.

Annex A forms an integral part of this standard whereas Annexes B, C and D are for information only.

The text of standard has been approved as suitable for publication as Indian Standard without deviations.Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularlydrawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should beread as ‘Indian Standard’; and

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practiceis to use a point (.) as the decimal marker.

(Continued on third cover)

IS 10654:2002ISO 7864:1993

Indian Standard

STERILE HYPODERMIC NEEDLESFOR SINGLE USE( Third Revision)

1 Scope

This International S’tandard specifies requirementsfor sterile hypodermic needles for single use ofnominal outside diameters 0,3 mm and 1,2 mm.

ISO 8601:1988, Data elements and interchange for-mats — /formation interchange — Representation ofdates and times.

ISO 9626:1991, Stain/ess steel needle tubing for themanufacture of medical devices.

It does not apply to dental needles.

3 Nomenclature

2 Normative references

The following standards contain provisions which,through reference in this text, constitute provisionsof this International Standard. At the time of publi-cation, the editions indicated were valid. All stan-dards are subject to revision, and parties toagreements based on this International Standardare encouraged to investigate the possibility of ap-plying the most recent editions of the standards in-dicated below. Members of IEC and ISO maintainregisters of currently valid International Standards.

ISO 594-1:1986, Conical fittings with a 6 % (Luer) ta-per for syringes, needles and certain other medicalequipment — Part 1.”General requirements.

ISO 594-2:1991, Conical fittings with a 6 % (Luer) ta-per for syringes, needies and certain other medicaiequipment — Part 2: Lock fittings.

ISO 3696:1987, Water for ana/ytica/ /aboratory use —Specification and test methods.

ISO 6009:1992, Hypodermic needles for single use –Colour coding for identification.

ISO 7886-1 :–1), Sterile hypodermic syringes for singleuse — Part 1: Syringes for manual use.

The nomenclature for components of hypodermicneedles for single use is shown in figure 1 togetherwith the designation for length L nomenclature forneedle points is shown in figure 2.

4 Cleanliness

When inspected by normal or corrected-to-normalvision without magnification under an illuminanceof 3(N) lx to 700 ix, the surface of the hypodermicneedle tube shall appear free from particles andextraneous matter.

When examined under x 2,5 magnification, the hubsocket shall appear free from particles and extrane-ous matter.

5 Limits for acidity or alkalinity

When determined with a laboratory pH meter andusing a general purpose electrode, the pH value ofan extract prepared in accordance with annex Ashall be within one unit of pH of that of the controlfluid.

6 Limits for extractable metals

When tested by a recognized microanalyticalmethod, for example by an atomic absorption

------

1) To be published,

1

. A-

IS 10654:2002ISO 7864:1993

method, an extract prepared in accordance with an-nex A shall, when corrected for the metals contentof the control fluid, contain not greater than a com-bined total of 5 mg/1 of lead, tin, zinc and iron. Thecadmium content of the extract shall, when cor-rected for the cadmium content of the control fluid,be lower than 0,1 mg/1.

7 Size designation

The size of hypodermic needle shall be designatedby the following:

a) the nominal outside diameter of the needle tube,expressed in millimetres;

b) the nominal length of the needle tube, expressedin millimetres.

The size shall be referred to as “the designatedmetric size” and shall be expressed in millimetres.

EXAMPLE

0,8 x 40

8 Colour coding

The nominal outside diameter of hypodermic nee-dles shall be identified by colour coding in accord-

Key

ante with ISO 6CX)9 applied to the unit containerand/or part of the needle assembly such as theneedle hub or the sheath.

9 Needle hub

9.1 Conical fitting

The conical socket of the hypodermic needle hubshall be in accordance with ISO 594-1.

If the hub has a locking fitting, it shall be in accord-ance with ISO 594-2.

9.2 Coiour of hub

The hub shall be made either of pigmented or ofunpigmented material. If pigmented, the colour shallbe in accordance with ISO 6009.

10 Sheath

If a separate needle sheath is provided, it shail bemade either of pigmented or of unpigmented ma-terial. If pigmented, the colour shall be in accord-ance with ISO 6009.

1 Hub2 Jolntlng madlum3 Needle tube4 Sheath

Figure 1 – Example of typical hypodermic needle and sheath for singie use

IS10654:2002

1S0

7864:1993

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IS 10654:2002ISO 7864:1993

11 Needle tube

11.1 General

The needle shall be made of tubing in accordancewith ISO 9626.

11.2 Tolerances on length

The actual length of the needle tube (see dimension/in figure 1) shall equal the nominal length within thetolerances given in table 1.

Table 1 – Tolerances on length of needle tubeDimensions in miilimetres

Nominal length of needle Tolerencetube

<25 +1-2

25 to 39 +1,5-2,5

40 0-4

>40+1,5-2,s

11.3 Freedom from defects

When examined by normal or corrected vision, theneedle tube shall appear straight and of regularcross-section and wall thickness.

11.4 Lubricant

If the hypodermic needle tube is lubricated, thelubricant shall not be visible, under normal or cor-rected vision, as droplets of fluid on the outside orinside surfaces of the needle tube.

NOTE t An acceptable lubricant, applied undiluted, ispolydimethylsiloxane complying with a national or theEuropean pharmacopoeia. The quantity of lubricant usedshould not exceed 0,25 mg per square centimetre of thesurface area of the needle tube.

12 Needle point

When examined under x 2,5 magnification, the nee-dle point shall appear sharp and free from featheredges, burrs and hooks.

NOTE2 The needle point usually has a bevel with aprimary bevel angle of (11 + 2)0 (as illustrated infigure2), but a “short” bevel with other angle, e.g.(17 + 2)0, maybe provided.

The designation of needle point dimensions and thenomenclature used to describe the dimensions andfeatures is shown for information in figure 2. The

needle points shown are of configurations com-monly manufactured: other configurations may beequally satisfactory. It may not be necessary to useall the dimensions when describing the point con-figuration.

The needle point should be designed so as to mini-mize coreing and fragmentation when penetratingvial closures. This International Standard does notspecify requirements or test methods for theseproperties, but an example of a test method for de-termining the production of fragments from rubberclosures is given in annex B.

13 Performance

13.1 Bond between hub and needle tube

The union of the hub and needle tube shall not bebroken by the minimum force given in table 2 ap-plied as push or pull in the direction of the needleaxis.

Table 2 – Force to test bond bptween hub andneedle tube

Nominal outside diameterof needle

mm

0,30,330,360,40,450,50,550,60,70,80,91,11,2

Force

min.

N

22

22

22

22

22

22

34

34

4044546969

13.2 Patency of lumen

The patency of the lumen shall be such that either

a)

b)

a stainless steel stylet of the appropriate diam-eter selected from the diameters given in table 3shall pass through the needle; or

the rate of flow of water through the needle un-der a hydrostatic pressure not exceeding

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4 I

1 x 105 Pazl shall be not less than 80 8/. of that ofa needle of equivalent outside diameter andlength having a minimum inside diameter in ac-cordance with ISO 9626 when tested under thesame pressure.

-, ...-,- –. –. ,-. .—1.–. ——.. —... —., .. —-. —

Extensions In rn!llimetres

Nominaloutside

diameter ofneedie

0,30,330,360,40,450,50,550,60,70,80,9I,t1,2

Diameter of stylet

for needieof normal-

walledtubing

0,110,110,110,150,180(180,220,250,300,400,480,580,7.0

0-0,01

for needieof

thin-walledtubing

0,130,150,150,190,230,230,270,290,350,420,490,600,73

for needieof

extra-thin-waliedtubing

——————.

0,300,370,440,500,680,83

14 Packaging

14.1 Primary container

Each hypodermic needle shall be sealed in a pri-mary container, The materiai and design of thiscontainer shall be such as to ensure that the colourcoding of the contents is visible.

The materials of the container should not have det-rimental effects on the contents. The materials anddesign of this container should be such as to ensure

a) the maintenance of sterility of the contents underdry, clean and adequately ventilated storageconditions;

b) the minimum risk of contamination of the con-tents during removal from the container

c) adequate protection of the contents duringnormal handling, transit and storage;

2) 1 standard atmosphere (atm) = 101325 Pa

1 technical atmosphere (at) = 98066,5 Pa

d)

IS 10654:2002

ISO 7864:1993

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that once opened, the container cannot be easilyresealed, and it should be obvious that the con--tainer has been opened.

14.2 Secondary container

One or more primary containers shall be packagedin a secondary container, ‘y

The secondary container should be sufficiently ro-bust to protect the contents during handling, transitand storage.

One or more secondary containers may beaged in a storage and/or a transit container.

15 Labelling

15.1 Primary container

pack-

The Drimarv container shall be marked with at leastthe followin-g information:

a) a description of the contents, including the des-ignated metric size in accordance with clause 7;

b) the word “STERILE”;

c) the lot number, prefixed by the word “LOT”;

d) the name or trade-mark or trade-name or logoof the manufacturer or supplier.

15.2 Secondary container

The secondary container shall be marked with atleast the following information:

a)

b)

c)

d)

e)

a description of the contents, including the des-ignated metric size in accordance with clause 7,the number, the type or angle of bevel (seeclause 12) and, if appropriate, the words “thin-walled” or “extra-thin-walled” or equivalent oran abbreviation;

the word “STERILE”;

the words “FOR SINGLE USE” or equivalent (ex-cepting the term “disposable”);

NOTE3 The symbol given in annex C may ad-ditionally be given.

a warning to check the integrity of each primarycontainer before use;

the lot number, prefixed by the word “LOT”;

. -----

IS 10654:2002ISO 7864: 1993

f) the date (year and month expressed as specifiedin subclause 5.2.1.1 of ISO 8601:1988) ofsterilization;

NOTE4 The date of sterilization may be incorpor-ated in the first several digits of the lot number.

g) the name and address of the manufacturer orsupplier;

h) information for handling, storage and transpor-tation.

15.3 Storage container

If secondary containers are packaged in a storagecontainer, the storage container shall be markedwith at least the following information:

a) a description of the contents as specified in15.2 a);

b) the lot number, prefixed by the word “LOT”;

c) the word “STERILE”;

d) the date of sterilization as specified in 15.2 9;

e) the name and address of the manufacturer orsupplien

f) information for handling, storage and transpor-tation of the contents.

15.4 Transport wrapping

If a storage container is not used but the secondarycontainers are wrapped for transportation, the in-formation required by 15.3 shall either be markedon the wrapping or shall be visible through thewrapping.

6

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Annex A(normative)

Method for preparation

A.1 Principle A.3

The needle, including the inside of the needle tube,is immersed in water in order to extract solublecomponents.

A.2 Apparatus and reagents

A.2.1 Freshly distilled or deionized water, of grade3 in accordance with ISO 3696.

A,2.2 Selection of laboratory borosilicate glass-ware.

IS 10654:2002

ISO 7864: 1993

of extracts

Procedure

A.3.1 Immerse 25 needles in 250 ml of water(A.2.1) in a suitable container made fromborosilicate glass (A.2.2). Ensure that all surfaces ofthe needles, including the inside of the needle tube,are in contact with the water. Maintain the water ata temperature of (37 ‘~) “C for (60 + 2) min. Re-move the needles and ensure that all water from theinside and outside surfaces of the needles is re-turned to the container.

A.3.2 Prepare the control fluid by following theprocedure given in A.3. I but omitting the needles.

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IS 10654:2002

ISO 7864: 1993

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Annex B(informative)

Example of method for determination of fragment production from rubber closures

B.1 Principle

Penetration of ISO rubber closures for injection vialsby the needle, and collection and counting of thefragments generated by the penetrations, Becausethe number of fragments generated is affected byvariables of needle desian, each ty~e of needle tobe tested is comparedreference needle.

B.2 Apparatus and

6.2.1 Injection vials, inor ISO 8362-4.

~ith the p-erformance of a

B.2.2 Rubber closures,ISO 8362-2, as follows:

Type A, nominal size 20

Hardness: 40 IRHD

reagents

accordance with ISO 8362-1

in accordance with

Base elastomer: Halogenated butyl.

B.2.3 Aiuminium caps, in accordance withISO 8362-3, having a central hole, to fit the injectionvials (B.2.1).

B.2.4 Hand-operated capping device, suitable forvials (B.2.1) and caps (B.2.3).

B,2.5 Membrane filter, of pore size 5 }lm, and filterholder.

6,2,6 Hypodermic syringe, of 10 ml nominal ca-pacity in accordance with ISO 7886-1.

6,2.7 Reference needles, of the same nominal out-side diameter of the type of needle to be tested, andhaving a nominal value of a (see figure2) of 13°,

8

B.2,8 Distilled or deionized water, of grade 3 in ac-cordance with ISO 3696.

B.3 Procedure

B.3.I Place n ml of water (B.2,8) into the vial(B.2.1), where n is 50 % of the nominal capacity ofthe vial.

B.3.2 Place a closure (8.2.2) on the vial and sealwith an aluminium cap (B.2.3) using the hand-operated capping device (B.2.4). Inspect the vial bynormal or Corrected-to-normal vision for the pres-ence of fragments, and discard any vial in whichrubber fragments are visible.

6.3.3 Fill the syringe (B.2.6) with water (B.2.8). At-tach a reference needle to the syringe and removeany water from the outside of the needle tube.

B.3.4 Place the vial vertically and, holding thesyringe vertically, pierce the closure.

B.3.5 Inject 2 ml of water into the vial, and with-draw the needle from the vial. Remove the needlefrom the syringe and replace it with a fresh refer-ence needle. Remove any water from the outside ofthe needle tube.

B.3.6 Repeat B.3.4 and B.3.5 for a total of fivepenetrations, choosing a different area of the clo-sure each time.

B.3.7 Repeat B.3.3 to 6.3.6 on a total of five vials,i.e. 25 reference needles and 25 penetrations in all.

B.3.8 Repeat B.3.3 to 6.3.7, using 25 needles of thetype to be tested.

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B.3.9 Remove the closure from the five vials fromB.3.7 and filter the contents through the membranefilter (B,2.5). Ensure that no fragments remain in thevial.

B.3.1O Repeat B.3.9 on the five vials from 6.3.8,using a second membrane filter.

B.3.11 Count and record the number of fragmentson each filter visible with normal or corrected visionwithout magnification, the distance between the eyeand the filter being (250 ~ 5) mm.

B.4 Test report

‘ The test reporf shall contain at least the followinginformation:

IS 10654:2002

ISO 7864:1993

a) the number of fragments generated by the refer-ence needles, as counted in B.3.1 I;

b) the number of fragments generated by the typeof needle tested, as counted in B.3,11;

c) the date of testing

B.5 Validity

Consider the results obtained from the test needlesto be invalid if the results from the reference nee-dles lack consistency with previous results. Deter-mine the reasons for the inconsistency.

.-

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---4IS 10654:2002

ISO 7864:1993/

i

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Annex C(informative) ,.

Symbol for “do not re-use”

C.1 General

The ISO symbol to denote equipment intended forsingle use is ISO symbol registration numberISO 7000/1051, given in ISO 7000:1989.

NOTE5 Further information on design, dimensions andapplication of ISO symbols is given in ISO 3461.

C.2 Original design

Symbol ISO 7000/1051 is shown in figure Cl.

The thickness of the lines is 2 mm. Dimension a isthe nominal size of the original design of all ISOsymbols and is normally made equal to 50 mm. Inmany cases, including ISO 7000/1051, the actual di-mension differs slightly, and the outside diameter of

r

the circle (dimension h) of the original design is I1,16 a, i.e. 58 mm.

No colour is specified in ISO 7000 or in this inter-national Standard for symbol 1051.

C.3 Reduction and enlargement oforiginal design

For the application of the symbol it may be neces-sary to reduce or enlarge the size of the original toa suitable size at which it will actually appear. Thenominal dimension a should be used as a gauge.Practice has shown that a may be reduced to 3 mmwithout the symbol losing its legibility. However, thelegibility of the symbol when reduced in size shouldbe checked.

Lh=l,ltia

NOTE– The visual centring lines do not form part of the symbol.

7

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,

Figure C.1 – ISO symbol for “do not re-use”, number ISO 7000/1051

10

IS 10654:2002

ISO 7864:1993

Annex D(informative)

Bibliography

[1] 1S0595-1 :1986, Reusable a//-assss or rneta/-and-glass syringes for medical use — Part 1:Dimensions.

[2] ISO 595-2:1987, Reusable a/1-glass or meta/-and-glass syringes for medical use — Part 2:Design, performance requirements and tests.

[3] ISO 3461-1:1988, Genera/ principles for thecreation of graphical symbols — Part 1:Graphical symbols for use on equipment.

[4] ISO 3461-2:1987, Genera/ principles for thecreation of graphica/ symbo/s — Part 2.”Graphical symbols for use in technical productdocumentation.

[5] ISO 7000:1989, Graphica/ symbols for use onequipment — Index and synopsis.

[6] ISO 8362-1:1989, Injection containers forinjectable and accessories — Part 1: Injectionvials made of glass tubing.

[7] ISO 8362-2:1988, Injection containers forinjectable and accessories — Part 2.” Closuresfor injection vials.

[8] ISO 8362-3:1989, Injection containers forinjectable and accessories — Part 3: Alu-minium caps for injection vials.

[9] ISO 8362-4:1989, h?jection containers forinjectable and accessories — Part 4: Injectionvials made of moulded glass.

[10] ISO 8537:1991, Sterile sing/e-use syringes, withor without needle, for insulin.

[11] ISO 10993-1:1992, Bio/ogica/ evacuation ofmedical devices — Part 1: Guidance on se-Iec(ion of tests.

.:..-.

11

(Continued from second cover)

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 Corresponding Degree ofStandard Indian Standard Equivalence

ISO 594-1:1986 IS 3234 (Part 1):1986 Conical fittings with a 6 Identicalpercent (Luer) taper for syringes, needles andother medical equipment: Part 1 Generalrequirements (second revision)

The technical committee responsible for the preparation of this standard has reviewed the provisionsof ISO 594-2, ISO 3696, ISO 6009, ISO 7866-1, ISO 8601 and ISO 9626, referred in this adoptedstandard, and has decided that they are acceptable for use in conjunction with this standard.

For the purpose of deciding whether a particular requirement of this standard is complied with, thefinal value, observed or calculated, expressing the result of a test, 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.

1

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‘.4

Bureau of Indian Standards

61S is a statutory institution established under the Bureau of Mian Standards Act, 1986 to promoteharmonious development of the activities of standardization, marking and quality certification of goodsand attending to connected matters in the country.

Copyright

61S has the copyright of all its publications. No part of these publications may be reproduced in anyform without the prior permission in writing of 61S. This does not preclude the free use, in the courseof implementing the standard, of necessary details, such as symbols and sizes, type or gradedesignations. Enquiries relating to copyright be addressed to the Director (Publications), 61S.

Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards arealso reviewed periodically; a standard along with amendments is reaffirmed when such review indi-cates that no changes are needed; if the review indicates that changes are needed, it is taken up forrevision. Users of Indian Standards should ascertain that they are in possession of the latest amend-ments or edition by referring to the latest issue of ’61S Catalogue’ and ‘Standards: Monthly Additions’.

This Indian Standard has been developed from Doc : No. MHD 12 (2822).

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

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