इंटरनेट मानक

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.

“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न' 5 तरफ”

Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”

IS 13601 (1993): Ethylene vinyl acetate (EVA) copolymers

for its safe use in contact with foodstuffs,
pharmaceuticals and drinking water [PCD 12: Plastics]

“!ान $ एक न' भारत का +नम-ण”

Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता ह”

है”
ह
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
 IS 13601 : 1993

( Reaffirmed 1998 )

Indian Standard
ETHYLENE VINYL ACETATE ( EVA )
COPOLYMERS FOR ITS SAFE USE IN CONTACT
WITH FOODSTUFFS, PHARMACEUTICALS AND
DRINKING WATER - SPECIFICATION

UDC 678 : 742-134.442.2 [ 663/664 : 614.8 ]

Q BIS 1993

BUREAU OF INDIAN STANDARDS

MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002 .

May 1993 Price Group 4

Plastics Sectional Committee, PCD 12

FOREWORD
This Indian Standard was adopted by the Bureau of Indian Standards, after the draft finalized
by the Plastics Sectional Committee had been approved by the Petroleum, Coal and Related
Products Division Council.
Plastics are now being used on a large scale for packaging of foodstuffs and pharmaceuticals.
Where direct contact occurs between the packed commodity and the plastics, the high molecular
mass polymer itself does not pose a toxic hazards being inert and essentially insoluble in food.
There is, however, a likelihood that some transfer may occur of polymer additives, adventitious
impurities such as monomers, catalyst remnants and residual polymerization solvents and of low
molecular mass polymer fractions from the plastics into the packaged material with consequent
toxic hazard to the consumers. The occurrence of acute toxicity due to plastics material in
contact with food is most unlikely, since only trace quantities of potentially toxic materials are
likely to migrate. However, the accumulation of these toxic materials with time may lead to
hazards which may be serious.
Ethylene vinyl acetate copolymers, commonly referred to as EVA copolymers or simply as EVA,
may be produced to cover the complete range of comonomer ratios form 99 : 1 ( ethylene : vinyl
acetate ) to 1 : 99. However, copolymers containing up to 50 percent vinyl acetate are classified
as thermoplastics. EVA copolymers are produced commercially by continuous bulk and solution
polymerization process.
EVA copolymer is an inert material and offers good flexibility and toughness even at low tem-
p erature, low heat sealing temperature, excellent environmental stress crack resistance, etc.
EVA copolymers are particularly useful in the packaging industry. EVA copolymers may be
injection moulded, blow moulded or extruded. EVA copolymers with vinyl acetate content
up to 18 percent may also be converted into films by conventional processing methods, such as
blown, co-extrusion, cast, lamination and coating.
EVA copolymers may be combined with other polymers in co-extrusion, for example, LDPE/
EVA, HDPE/EVA, BOPP/EVA, Polyester/EVA, etc, giving improved performance in flexible
packaging in the form of multllayer films which are widely used for food packaging.
EVA copolymers may also be blended with other polymers like LDPE, HDPE, PP, PVC, etc, to
improve properties such as impact, flexibility and easy heat sealability.
EVA copolvmers are considered as safe for use as articles or components of articles intended
for safe use in contact with foodstuffs, in accordance with the code of Federal Regulation, FDA
( USA ) ( 28 CFR 177. 1350 ).
This standard is intended to be used with the series of Indian Standards on plastics for food
contact applications which is given in Annex A.
It is emphasized that these standards need to be used in combination to provide a system of
control to the manufacturers of plastics as well as the fabricators of thermoplastic packaging
materials to derive maximum benefits. Besides, it may also serve as basis for official agencies to
frame suitable legislation to ensure effective safeguards for the safety and health of consumers
where thermoplastics for food contact applications are concerned.
For the purpose of deciding whether a particular requirement of this standard is complied
with, the final value, observed or calculated, expressing the result of a test, shall be
rounded off in accordance with IS 2 : 1960 ‘Rules for rounding off numerical values ( revised)‘.
The number of significant places retained in the rounded off value should be the same as that of
the specified value in this standard.

.
 IS 13601:19!U

Indian Standard
ETHYLENE VINYL ACETATE ( EVA )
COPOLYMERS FOR ITS SAFE USE IN CONTACT
WITH FOODSTUFFS, PHARMACEUTICALS AND
DRINKING WATER - SPECIFICATION
1 SCOPE 4 REQUIREMENTS
1.1This standard specifies the requirements 4.1 Basic Resins
and methods of sampling and test of ethylene
vinyl acetate ( EVA, ) copolymer for the manu- A basic resin produced by the co-polymeriza-
facture of plastic items used in contact with tion of ethylene and vinyl acetate.
foodstuffs, pharmaceuticals and drinking water. 4.1.1 Vinyl Acetate (VA) Content
1.2 This standard does not purport to establish In the EVA copolymers, the VA content shall
the suitability of the packing media with parti- be between 3 percent and 50 percent when
cular foodstuffs, pharmaceuticals and drinking tested in accordance with the methods prescri-
water, from other than toxicological considera- bed in Annex B.
tions.
4.1.2 Additive Concentrates
2 NORMATIVE REFERENCES
The total level of slip agent and/or anti-block
The following standards contain provisions agent added to the copolymer shall not exceed
which through reference in this text, constitute 2.5 percent by mass.
provisions of this standard. At the time of
publication the editions indicated were valid. 4.2 Material
All standards are subject to revision, and
parties to agreements based on this standard The material shali also comply with the thres-
are encouraged to investigate the possibility of hold limits of the manufacturing residues,
applying the most recent editions of the polymerization ingredients, auxiliary items as
standards indicated below: prescribed in IS 13449 : 1992.

Title
4.3 Pigments and Colourants
IS No.
In case coloured material is used for food
4905 : 1968 Methods for random sampling packaging applications, it shall comply with the
9833 : 1981 List of pigments and colourants list and limits of the pigments and colourants
for use in plastics in contact prescribed in IS 9833 : 1981.
with foodstuffs, pharmaceuti-
cals and drinking water 4.4 Overall Migration
9845 : 1986 Methods of analysis for the The material shall also comply with the overall
determination of specific and/ migration limits of 60 mg/l, Max of the simu-
or overall migration of consti- lant and 10 mg/dm2, Max of the surface of the
tuents of plastics materials and material or article, when tested by the method
articles intended to come into prescribed in IS 9845 : 1986.
contact with foodstuffs, phar-
maceuticals and drinking water 4.5 Storage and Control
13449 : 1992 Positive list of constituents of 4.5.1 Storage
ethylene vinyl acetate (EVA )
copolymers for safe use in con- Plastics materials intended for food contact use
tact with foodstuffs, pharma- shall be stored separately from other materials
ceuticals and drinking water in closed, properly identified containers.

3 TERMINOLOGY 4.5.2 Control

For the purpose of this standard, the definitions An authorized person shall supervise and
given in IS 13449 : 1992 shall apply. control the issue of plastics materials to the

1
IB 13601:1993

process or manufacturing area and shall main- accordance with the EEC Directive 80/590/EEC
tain appropriate written records of the issue of ‘Symbol’ that shall accompany materials and
such materials. articIes intended to come into contact with
foodstuff ):
AS.3 Adequate standards of hygiene shall be
maintained at all times and plant operators
and storemen shall be trained in proper hygiene
practices.
5 PACKING AND MARKING
5.1 Packing
The material shall be packed in paper/plastics
bags with suitable liner, as agreed between the
purchaser and the supplier, in a manner so as
to ensure that the items do not become conta-
minated during storage.
5.2 Marking
5.2.1 Each package ‘shall be clearly marked
with the following information:
a) Indication of the source of manufacture,
and trade-mark, if any;
b) Name and type of material; 5.2.3 The package may also be marked with the
c) .Month and year of manufacture; Standard Mark.
d) Net mass of the material; and 6 SAMPLTNG
e) Lot and batch number.
The method of drawing representative sample
5.2.2 The package shall also carry the following of the material and the criteria for conformity
symbol clearly embossed/printed on it ( in shall be as prescribed in Annex C.

ANNEX A
( Foreword )
LIST OF INDIAN STANDARDS ON PLASTICS FOR FOOD CONTACT APPLICATIONS

IS No. Title IS No. Title

9833 : 1981 List Of pigments and colourants 10142 : 1982 Specification for styrene poly-
for use in plastics in contact mers for its safe use in contact
with foodstuffs, pharmaceuti- with foodstuffs, pharmaceuti-
cals and drinking water cals and drinking water
9845 : 1986 Method of analysis for the
determination of specific and/or 10146 : 1982 Specification for polyethylene
overall migrations of consti- for its safe use in contact with
tuents of plastic materials and foodstuffs, pharmaceuticals and
articles intended to come into drinking water
contact Mith foodstuffs ( first
revision ) 10148 : 1982 Positive list of constituents of
1.0141 : 1982 Positive list of constituents of polyvinyl chloride ( PVC! ) and
polyethylene in contact with its copolymers in contact with
foodstuffs? pharmaceuticals and foodstuffs, pharmaceuticals
drinking water and drinking water

2
 IS 13601: 1993

IS No. Title IS No. Title

10149 : 1982 Positive list of constituents of in contact with foodstuffs,
styrene polymers in contact pharmaceuticals and drinking
with foodstuffs, pharmaceuti- water
cals and drinking water 12247 : 1988 Specification for Nylon 6 poly-
10151 : 1982 Specification for polyvinyl chlo- mer for its safe use in contact
ride (PVC) and its copolymers with foodstuffs, pharmaceuti-
for its safe use in contact with cals and drinking water
foodstuffs, pharmaceuticals and 12248 : 1988 Positive list of constituents of
drinking water Nylon 6 polymer for its safe
10171 : 1986 Guide on suitability of plastics use in contact with foodstuffs,
for food packaging ( first pharmaceuticals and drinking
revision ) water
10909 : 1984 Positive list of constituents of 12252 : 1987 Specification for polyalkylene
polypropylene and its copoly- terephthalates,,( PET and PBT-)
mers in contact with foodstuffs, for their safe use in contact
pharmaceuticals and drinking with foodstuffs, pharmaceuti-
water cals and drinking water
10910: 1984 Specification for polypropylene 12229 : 1987 Positive list of constituents of
and its copolymers for its safe polyalkylene terephthalates
use in contact with foodstuffs, ( PET and PBT ) for their safe
pharmaceuticals and drinking use in contact with foodstuffs,
water pharmaceuticals and drinking
water
11434: 1985 Specification for ionomer resins
for its safe use in contact with 13449 : 1992 Positive list of constituents of
foodstuffs, pharmaceuticals ethylene vinyl acetate ( EVA )
and drinking water copolymers in contact with
foodstuffs, pharmaceuticals and
10435:1985 Positive list of constituents/ drinking waler
ionomer resin for its safe use
in contact with foodstuffs, 13576 : 1992 Ethyiene methacrylic acid
pharmaceuticals and drinking (EMAA) copolymers and
water terpolymers for their safe use
in contact with foodstuffs,
11704 : 1986 Specification for ethylene/ pharmaceutical and drinking
acrylic acid ( EAA ) copoly- water - Specification
mers for their safe use in con- 13577 : 1992 Positive list of constituents of
tact with foodstuffs, pharma-
ethylene methacrylic acid
ceuticals and drinking water
(EMAA) copolymers and
11705 : 1986 Positive list of constituents of terpolymers in contact with
ethylene/acrylic acid ( EAA ) foodstuffs, pharmaceuticals and
copolymers for their safe use drinking water - Specification

ANNEX B
( CZause 4.1.1 )
DETERMINATION OF VINYL ACETATE CONTENT IN ETHYLENE VINYL
ACETATE ( EVA ) COPOLYMERS
B-l METHOD-I BY PYROLYSIS vapourized acetic acid into the absorbing
B-l.1 Outline of the Method Solution.
The polymer is pyrolysed at 400°C. The pyro- B-2 APPARATUS
lysate is bubbled through sodium hydroxide
solution where acetic acid formed during pyro- B-2.1 Any suitable combustion furnaces capable
lysis is absorbed. Excess sodium hydroxide is of being maintained at a temperature of 4OOC.
then back titrated with standard hydrochloric
acid ( Cr.1N ) solution using phenolphthalein as B-2.2 Combustion tube with B 29 ground glass
indicator. A nitrogen purge is used to force the joints - Outside diameter 32 mm, length 36 mm.

3
Ls13601:1993

B-2.3Prefabricated ground glass joint to fit the B-5 CALCULATION

pyrolysis tube ( gas disperser ).
Calculate the percent vinyl acetate ( VA )
B-2.4Quartz boat to fit inside the combustion content using formula:
tube. ,,, VA = (b-a) ;” x 8*61
,‘u * *
B-2.5Tall form bubbler, 500 ml capacity.
where
B-2.6Pipette, 25-ml.
b is the amount of HCI consumed for blank
B-2.7Burette, 50-ml, with stand and holder. determination ( B-4.2 ),
A is the amount of HCI consumed for black
B-2.8Regulated nitrogen supply.
titration ( B-4.8 ),
B-3 REAGENTS N is the normality of HCl solution, and
W is the weight of the sample taken
B-3.1Standard hydrochloric acid ( HCL )
( B-4.1 ).
solution, 0.1 N.
B-6 METHOD-II BY INFRA-RED ( IR )
B-3.2 Sodium hydroxide ( NaOH ) solution, SPECTROPHOTOMETRY
0.1 N ( approx ).
B-6.1 General
B-3.3 Phenolphthalein indicator solution, O-1 This method describes infra-red spectrophoto-
percent, prepared by dissolving 0.1 g of phenol- metric procedure for the determination of
phthalein in 60 ml neutralized rectified spirit combined and free vinyl acetate, when carbon
and diluting to 100 ml with distilled water. black is absent. The method of determination
is applied directly to a hot pressed plate of
B-3.4 Distilled water.
accurately known thickness.
~-4 PROCEDIJRE Two different procedures are used for diRerent
B-4.1 Depending upon vinyl acetate content, ranges of copolymerized vinyl acetate.
weigh accurately 0.4-0.6 g of EVA sample into i ) For the range 5-20 percent combined
a quartz boat. vinyl acetate, plate of 0.38 f 0.05 mm
thickness is used and measurements are
B-4.2 Measure 25-ml 0.1 N sodium hydroxide made of the absorption band at
solution into a 500-ml tall form bubbler. Back 3460 cm”, due to carbonyl overtone of
titrate with standard 0.1 N hydrochloric acid vinyl acetate.
to determine equivalent number of millilitres
required to neutralize 25 ml of 0.1 N sodium The determination is not affected by the pre-
hydroxide. sence of vinyl acetate monomer.
ii) For the higher range of 20-35 percent
B-4.3 Connect the gas disperser and 500 ml combined vinyl acetate, plate of 3.8
tall form bubbler to the combustion tube, ho.25 mm thickness is used and measure-
making sure that the gas disperser is well below ments are made of the absorption band
the level of the absorbing sodium hydroxide at 4688 cm-l, due to carbonyl combina-
solution. tion overtone of vinyl acetate.
B-4.4 Adjust the flow of nitrogen to 350-400 Up to 5 percent free vinyl acetate monomer can
ml/min. be tolerated in this procedure.

B-4.5 Insert the sample into the combustion B-7 PRINCIPLE

tube and quickly connect the nitrogen purge. The determination of free vinvl acetate is
Heat the sample at 400°C for 1 h. based on the measurement of the-band at 6210
cm-’ due to C=C! stretching mode of - CH =
B-4.6 Sample should be left in the combustion CH, group in vinyl acetate monomer. The
furnace for at least 20-25 minutes. contribution of the end group structure
B-4.7 After the prescribed time, stop heating - CH, - C--O - CH=CH, amounts to only
and rinse the disperser with distilled water.
g
B-4.8 Add 10 drops of phenolphthalein indica- 0.03 percent calculated as vinyl acetate
tor to the absorbing solution and back titrate monomer for copolymers containing 30 percent
with standard 0.1 N hydrochloric acid. ( Change and 40 percent W/W vinyl acetate and can
of colour -~ Pink to colourless ). thus be ignored.

4 .
 IS 13601: 1993

B-8 APPARATUS B-10.4 Take out absorbance of sample of nearly

same thickness and compare the absorbance of
B-8.1 IR Spectropbotometer - Range 350 cm-l the sample with the absorbance of standard
-7 000 cm’*. plates.
B-8.2 Hydraulic Press - Capacity 10 tons. NOTES
1 For520 percent combined vinyl acetate content
B-8.3 Press plates and spacer. take absorption spectra from 3050 cm-1 to 3 800 cm-l.
2 For 20-35 percent combined vinyl acetate content
B-8.4 Dial gauge micrometer ( 1 div = 0.002 take absorption spectra from 4 500 cm-1 to 6 000 cm-l.
mm ).
B-11 CALCULATION
B-8.5 Melinex Film - thickness 100 microns.
NOTE - Melinex is a trade-name of a film made of
Calculate the percent vinyl acetate content as
polyethylene terephthalates ( PET), supplied by M/S follows:
Mehta Enterprise, Bombay. Other equivalent films 9/, Concentration Thickness of
may also be used.
o/0Vinvl on the screen or x Standard
B-9 PREPARATION OF TEST SPECIMEN acetate = calibration cenrte plate
B-9.1 For Samples Having 5-20 percent Com- Thickness of sample plate
bined Vinyl Acetate B-12 METHOD OF OPERATION OF
,Obtain a specimen of the sample 0.38hO.05 mm TYPICAL HYDRAULIC PRESS
thickness bv pressing between stainless steel B-12.1 Press Details
plates, melinex film.
Upstroke, single acting, electrically heated
Measure accurately the mean thickness of,the rubber moulding hydraulic press having the
sample to the nearest 0.002 mm with a dial- following specification:
gauge micrometer, taking the measurements - Tons
along the centre line of the length of the a) Capacity
b) Types - 4 pillar type
moulded sample.
c) Platen size - 200 mm x 200 mm
Record the average of ten values as thickness
d) Daylites - Single daylite
of the sample.
4 Daylite gap - 75 mm
B-9.1.1 Required dimensions of the specimen
are: f ) Ram diameter - 75 mm
50 x 50 mm g) Ram stroke - 75 mm
75 x 75 mm h) Working pressure - 210 kg
100 x 100 mm j) Mode of heating - Electrical with tem-
150 x 150 mm perature controller
k) Heaters - 6 No. heaters of
Out of these four dimensions any one size of
spacer can be used. capacity 1 kW each
m) Cooling - Water cooling in
B-9.2 For Samples Having 20-35 percent W/W arrangement heating plates
Combined Vinyl Acetate - Hand operated by
n) Mode of
Prepare a specimen of the sample as per the operation D.C. valve
available spacer as given in B-9.1.1, 3.8 &
0.25 mm in thickness by pressing between p) Max temperature - 250°C
stainless steel plates and melinex film. Measure B-12.2 Operation
accurately the mean thickness of the sample
in accordance with B-9.1. B-12.2.1 Start the main switch, set the required
B-10 PROCEDURE temperature both top and bottom temperature
controller.
B-10.1 Obtain a specimen of the standard B-12.2.2 As soon as the charging temperature
sample prepared as per B-9. is attained, insert the plate. Weigh the EVA
B-10.2 Take absorbance of more than two granules as per the grade spacer thickness
different standard plates of some grade, and the ( see B-12.2 ).
said range of vinyl acetate content having B-12.2.3 Start the motor. Operate the lever
nearly the same thicknesses. downwards direction. Keep the plate so that
B-10.3 Prepare a calibration curve using these there is positive pressure, then switch off
.absorbance values. motor.

5
 IS 13601 : 1993

B-12.2.4 Wait till the set temperature is B-13.2 Type CONFIG, ENTER and then press
reached. Fl. Then press Est. Press Y ENTER.
B-12.2.5 Pressurize with help of motor and
lever to 5 tons for the scheduled time B-13.3 Type BOMEN ENTER and then press
( see B-12.2.8 ). any key to continue. Original menu will be
displayed on the screen.
B-12.2.6 Stop heaters and open the water tap
for cooling. As soon as the room temperature B-13.4 Press Fl ( reference ) and feed appro-
is reached, release pressure and remove the priate range as per the requirement. Press Fl
plates. ( start acquisition ). Once the reference
B-12.2.7 Clean the spacer by acetone or xylene. spectrum appears on the screen, then press Est.
Original menu will be displayed.
B-12.2.8 Operating conditions of hydraulic
press are as under: B-13.5 Keep the sample in the sample compart-

Vinyl Set Charge Sample High Pressure Cooling

Acetate Ternp on Contact ~.__-~--__ -> Time,
Content, “C! Pressure at Temp Pressure Thickness Time, Min
Percent Temperature “C Tons Min
07 - 02 140 90 140 5
15

12 - 02 130 80 130 15
14 ‘- 08 125 75 125 15
18 -02 120 70 120 15
18 - 10 120 70 120 15
28 - 06 100 50 95 15
28 - 25 90 40 85 15
28 - 150 80 40 75 10
28 - 350 65 40 65 10
28 - 400 65 40 65 10
B-12.2.9 Switch off the heaters at the time of applying high pressure.

B-12.2.10 For sample containing 28 percent vinyl acetate, put in ice water for 5 minutes after
machine cooling.

B-12.2.11 Weight of the sample to be taken as per the size of the spacer as follows:
Spacer Thickness, Spacer Size, Material EVA Grade
mm mm Quantity, g
0.38 150 x 150 9 07-02, 12-02,
14-08, 18-02,
18- 10
0.38 150 x 150 75 26-06, 28-25,
28-25, 28- 150,
28-350, 28-400

B-13 OPERATION OF TYPICAL FTIR ment and feed sample details. Then press F3
( BOMEN MODEL - MB 100 ) (absorbance). Press Fl (start acquisition). After
few minutes sample spectrum will be displayed
B-13.1 Switch on computer and monitor. On on the screen. Then press Esc, till the original
the screen C:/> will be displayed. menu appears.

6
 1S13601:1993

B-13.6Press F5 ( display ) to confirm whether B-13.7.2 Type method name and then press
it is saved or not. Then press Esc to get ENTER. If the results are to be printed, then
original menu. press Fl ( see that printer is connected ). Press
F3 ( select files and RUN ).
B-13.7 For quantitative estimation of vinyl
acetate content in plate follow steps mentioned B-13.7.3 Mark files to analyse by pressing space
below. bar. Move the cursor from experiment to sub
files by pressing arrow keys and then press
B-13.7.1 Press F6 - Batch analysis space bar and press ENTER.
Press Fl - Quantitative analysis B-13.7.4 Concentration will be displayed on the
Press P2 - Run method screen.

ANNEX C
( Clause 6.1 )
SAMPLING OF ETHYLENE VINYL ACETATE ( EVA ) COPOLYMERS
#C-l GENERAL a consignment is known to consist of packages
belonging to the different batches of manufacture
C-l.1 In drawing, preparing, storing and hand- of different forms, the packages belonging
ling samples, the following precautions and to the same batch of manufacture and same
directions shall be observed. form shall be grouped together and each such
C-l.2 Sample shall not be taken in an exposed group shall constitute a lot.
place. C-2.2 For ascertaining the conformity of the
C-l.3 The sampling instrument, whenever appli- material to the requirements of this specifica-
cable, shall be made of stainless steel or any tion, samples shall be tested from each lot
other suitable material on which the material separately. The number of packages to be
shall have no action. The instrument shall be sampled shall depend on the size of the lot and
clean and dry. shall be in accordance with co1 1 and 2 of
Table 1.
C-1.4 Precautions shall be taken to protect
the samples, the material being sampled, the Table 1 Scale of Sampling
sampling instrument and the containers for
samples from adventitious contamination. No. of Packages Sample Size
in the Lot
C-1.5 The samples shal1 be placed in a suitable, (1) (2)
clean, dry, air-tight metal or glass containers up to 50 3
on which the material has no action. The 51 to 150 4
sample containers shall be of such a size that 151 to 300 5
they are almost completely filled by the sample. 301 to 500 7
C-l.6 Each sample container shall be sealed 501 and above 10
air-tight with a stopper after filling and marked
with full details of sampling, such as the date C-2.2.1 These packages shall be selected at
of sampling, the month and year of manufacture random from the lot and in order to ensure the
of the material, etc. randomness of selection, procedures given in
IS 4905 : 1968 may be followed.
C-l.7 Samples shall be stored in such a manner
that the temperature of the material does not C-3 PREPARATION OF TEST SAMPLES
vary unduly from the normal temperature.
C-3.1 From each of the packages of material
SC-2 LOT selected, small portions of material shall be
,C-2.1 In a single consignment all the packages drawn with the help of a suitable sampling
of the same class, same type, same form and instrument. The total quantity of material col-
belonging to the same batch of manufacture lected from each package shall be sufficient to
shall be grouped together to constitute a lot. If test all the requirements given in 4.

7
.
IS13601:1993

C-3.2In the case of packages consisting of con- The lot shall be declared as conforming to the
tainers vials, rolls or films the number of items requirements of various characteristics if:
to be selected from a package for testing each
of the requirements given in 4 shall be one. X+ KR < the maximum value specified; and
where the value of K shall be chosen from
C-4 NUMBER OF TESTS table given below:
The tests for determining all the requirements Value of K for Various Sizes and AQL
given in 4 shall be carried out on the individual
test samples. _-
Sample A&L
C-5 CRITERIA FOR CONFORMITY Size r--- 1,_-__,

From the individual test results calculate the - 0.65

1.00 1.50 2.50 4.00
average ( X) and the range ( A ) 3 - - - 0.587 0.502
where 4 - 0.651 0.598 0.525 0.450
x = Sum of the test results 5 0.663 0.614 0.565 0.496 0.431
Number of tests 7 0.613 0.696 0.525 0.465 0.405
R - difference between the maximum and 10 0.755 0.703 0.650 0.579 0.507
the minimum values of the test results
Standard Mark
The use of the Standard Mark is governed by the provisions of the Bureau of Indian
Standards Act, 1986 and the Rules and Regulations made thereunder. The Standard Mark
on products covered by an Indian Standard conveys the assurance that they have been
produced to comply with the requirements of that standard under a well defined system
of inspection, testing and quality control which is devised and supervised by BIS and
operated by the producer. Standard marked products are also continuously cheked by
BIS for conformity to that standard as a further safeguard. Details of conditions under
which a licence for the use of the Standard Mark may be granted to manufacturers or
producers may be obtained from the Bureau of Indian Standards.

.
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

Revision of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards
are also reviewed periodically; a standard along with amendments is rea5rmed 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 Indin Standards should ascertain that they are in possession of the
latest amendments or edition by referring to the latest issue of ‘BIS Handbook’ and ‘Standards
Monthly Additions’. Comments on this Indian Standard may be sent to BIS giving the following
reference:

Dot : No. PCD 12 ( 905 )

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

BUREAU OF INDIAN STANDARDS

Headquarters:
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Telephones : 331 01 31, 331 13 75 Telegrams : Manaksanstha
Common to all 05ces )

Regional Offices : Telephone

Central : Manak Bhavan, 9 Bahadur Shah Zafar Marg 33101 31
NEW DELHI 110002 C 331 13 75
Eastern : l/14 C. I. T. Scheme VII M, V. I. P. Road, Maniktola r37 84 99, 37 85 61
CALCUTTA 700054 *i37 56 26, 37 86 62
f-53 38 43, 53 16 40
Northern : SC0 445-446, Sector 35-C, CHANDIGARH 160036 153 23 84
235 02 16, 235 04 42
Southern : C. I. T. Campus, IV Cross Road, MADRAS 600113
235 15 19, 235 23 15
Western : Manakalaya, E9 MIDC, Marol, Andheri ( East ) 632 92 95, 632 78 58
BOMBAY 400093 632 78,91, 632 78 92
Branch : AHMADABAD. BANGALORE. BHOPAL. BHUBANESHWAR. COIMBATORE.
FARIDABAD. GHAZIABAD, GUWAHA’II. HYDERABAD. JAIPUR. KANPUR
LUCKNOW. PATNA. THIRUVANANTHAPURAM. ‘

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