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BS 6256-1989 - (2018-06-20 - 03-48-04 Am)

BS 6256

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0% found this document useful (0 votes)
263 views14 pages

BS 6256-1989 - (2018-06-20 - 03-48-04 Am)

BS 6256

Uploaded by

Rankie Choi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 14

BRITISH STANDARD BS 6256:1989

Incorporating
Amendment No. 1

Paper for steam


sterilization paper
bags, pouches and reels
for medical use

UDC 676.24:621.798.156:615.4:006.3/.8

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW


BS 6256:1989

Committees responsible for this


British Standard

The preparation of this British Standard was entrusted by the Packaging and
Freight Containers Standards Policy Committee (PKM/-) to Technical
Committee PKM/566, upon which the following bodies were represented:

British Aluminium Foil Rollers’ Association


British Paper and Board Industry Federation
Department of Health and Social Security
Institute of Sterile Services Management
Medical Sterile Products Association
Ministry of Defence
Packaging and Industrial Films Association
Pira (Research Association for the Paper and Board, Printing and Packaging
Industries)
Pharmaceutical Society of Great Britain
Retail Bag Manufacturers’ Association
Sterilisation Packaging Materials Association
United Kingdom Sugar Industry Association

This British Standard, having


been prepared under the
direction of the Packaging and
Freight Containers Standards
Policy Committee, was
published under the authority of
the Board of BSI and comes into
effect on 28 February 1990

© BSI 06-2001

First published September 1982


Amendments issued since publication
Second edition February 1990
Amd. No. Date of issue Comments

10778 June 2001 Indicated by a sideline


The following BSI references
relate to the work on this
standard:
Committee reference PKM/566
Draft for comment 88/45972 DC

ISBN 0 580 18015 8


BS 6256:1989

Contents

Page
Committees responsible Inside front cover
Foreword ii
1 Scope 1
2 Materials and manufacture 1
3 Performance 1
4 Sampling 2
5 Packaging 2
6 Marking of reels and outer packaging 2
Appendix A Method for determination of fluorescence 3
Appendix B Method for determination of water repellency 3
Appendix C Method for determination of methylene blue
particulate penetration 4
Figure 1 — Circuit diagram of apparatus for methylene blue
particulate penetration test 6
Figure 2 — Test piece holder for methylene blue particulate
penetration test 7
Table 1 — Summary of performance requirements and test methods 8
Publications referred to Inside back cover

© BSI 06-2001 i
BS 6256:1989

Foreword

This revision of BS 6256 has been prepared under the direction of the Packaging
and Freight Containers Standards Policy Committee. It supersedes
BS 6256:1982 which is withdrawn.
This edition adds a requirement for grammage.
Since no requirement is specified in this standard for dimensions it is essential
that the purchaser state in his order the width of paper required.
With effect from November 1999 the normative text of this standard was
superseded by that of BS EN 868-3:1999. However it has proved necessary to
retain BS 6256:1989 as a current standard for an interim period, due to
cross-reference to Appendix C of that standard in BS EN 868-1:1997, annex D.
This cross-reference regards permissible test methods for the microbial barrier
properties of materials: the methylene blue particulate penetration test being one
such method.
It should be noted that Appendix C makes reference in turn to BS 2577:1995,
itself a withdrawn standard. Users of BS 6256 requiring a copy of BS 2577:1995
should direct their request to the library of the British Standards Institution at
the following address: BSI, 389 Chiswick High Road, London W4 4AL.
A British Standard does not purport to include all the necessary provisions of a
contract. Users of British Standards are responsible for their correct application.
Compliance with a British Standard does not of itself confer immunity
from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, pages i and ii,
pages 1 to 8, an inside back cover and a back cover.
The BSI copyright notice displayed in this document indicates when the
document was last issued
Sidelining in this document indicates the most recent changes by amendment

ii © BSI 06-2001
BS 6256:1989

1 Scope
This British Standard specifies requirements for materials, performance, marking and packaging for paper
used in the manufacture of steam sterilization paper bags to BS 6257 and pouches and reels to BS 6871.
NOTE The titles of the publications referred to in this standard are listed on the inside back cover.

2 Materials and manufacture


2.1 The furnish of the paper shall be bleached chemical wood pulp, free from dirt and from unpleasant
odour when dry or wet. Waste paper, other than “broke” of the same furnish, shall not be used
(see BS 3203).
2.2 The furnish shall be treated with synthetic resin in order that the paper complies with 3.7 and 3.9. The
paper shall not leave fluff or fibre during normal use.
2.3 The paper shall be supplied on rolls.
2.4 The paper shall be white. No toxic materials or colour shall leach out of the paper.
3 Performance
NOTE A summary of performance requirements and test methods is given in Table 1.

3.1 Grammage
The grammage of the paper shall be not less than 56 g/m2 when:
a) conditioned in accordance with BS 3431 at 23 ± 1 °C and 50 ± 2 % r.h.;
b) tested in accordance with BS 3432.
3.2 pH of water extract
The pH of water extract of the paper shall be not less than 5 nor greater than 8 when tested in accordance
with BS 2924-1.
3.3 Chloride content
The chloride content calculated as sodium chloride (NaCl), of the paper shall be not more than 0.05 % when
tested in accordance with BS 2924-4.
3.4 Sulphate content
The sulphate content, calculated as sodium sulphate (Na2SO4), of the paper shall be not more than 0.25 %
when tested in accordance with BS 2924-3.
3.5 Fluorescence
The paper shall neither exhibit a general fluorescence nor have more than five fluorescence spots each
having an axis greater than 1 mm when tested in accordance with Appendix A.
3.6 Bursting strength
The bursting strength of the paper shall be not less than 230 kPa when:
a) conditioned in accordance with BS 3431 at 23 ± 1 °C and 50 ± 2 % r.h.;
b) tested in accordance with BS 3137.
3.7 Wet bursting strength
The wet bursting strength of the paper shall be not less than 35 kPa when tested in accordance with
BS 2922-1, using an immersion time of 10 min.
3.8 Tensile strength
The tensile strength of the paper shall be not less than 4.67 kN/m in the machine direction and not less
than 2.33 kN/m in the cross direction when:
a) conditioned in accordance with BS 3431 at 23 ± 1 °C and 50 ± 2 % r.h.;
b) tested in accordance with BS 4415-2, in the atmospheric conditions specified in 3.8a).

© BSI 06-2001 1
BS 6256:1989

3.9 Wet tensile strength


The wet tensile strength of the paper shall be not less than 0.87 kN/m in the machine direction and not less
than 0.43 kN/m in the cross direction when tested in accordance with BS 2922-2 and using an immersion
time of 1 min.
3.10 Internal tearing resistance
The internal tearing resistance of the paper shall be not less than 550 mN in both the machine and cross
directions when:
a) conditioned in accordance with BS 3431 at 23 ± 1 °C and 50 ± 2 % r.h.;
b) tested in accordance with BS 4468, using a single tear tester.
3.11 Water repellency
The water repellency of the paper shall be such that the penetration time is not less than 20 s when tested
in accordance with Appendix B.
3.12 Methylene blue penetration
The methylene blue penetration of the paper shall be not more than 20 % at a linear air flow of 300 mm/min
when tested in accordance with Appendix C.
3.13 Air permeance (Bendtsen): medium range
The air permeance of the paper shall be not less than 3.4 "m/Pa·s at an air pressure of 1.47 kPa when
tested in accordance with BS 6538-2.
3.14 Surface absorbency
The surface absorbency of each side of the paper shall be not more than 17 g/m2 when:
a) conditioned in accordance with BS 3431 at 23 ± 1 °C and 50 ± 2 % r.h.;
b) tested in accordance with BS 2644, using an exposure time of 60 s.
3.15 Bendtsen roughness
The Bendtsen roughness of one surface of the paper shall be not greater than 350 mL/min when:
a) conditioned in accordance with BS 3431 at 23 ± 1 °C and 50 ± 2 % r.h.;
b) tested in accordance with BS 4420.
4 Sampling
Where sampling is undertaken for verification purposes, this shall be carried out in accordance with
BS 3430.
5 Packaging
The paper shall be packed in trade packages of a type normally used for commercial deliveries of the same
or similar items either in retail or in bulk quantities within the United Kingdom or overseas.
6 Marking of reels and outer packaging
Each package shall be legibly and durably marked with the following information:
a) reference, stock or catalogue number;
b) description (including the number and date of this British Standard, i.e. BS 6256:19891));
c) number of reels and weight;
d) supplier’s name or trademark;
e) contract number (where applicable);
f) date of manufacture (month and year);
g) batch number.

1)Marking BS 6256:1989 on or in relation to a product represents a manufacturer’s declaration of conformity, i.e. a claim by or
on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is therefore
solely the responsibility of the person making the claim. Such a declaration is not to be confused with third party certification of
conformity which may also be desirable.

2 © BSI 06-2001
BS 6256:1989

Appendix A
Method for determination of fluorescence
A.1 Apparatus
A.1.1 Ultraviolet (UV) light source, with a peak output at 366 nm. The luminous output of the lamp shall
be such that the required surface illumination of the test piece given in A.2 is obtained.
A.2 Procedure
Cut a test piece from the paper 100 mm × 100 mm and condition it in accordance with BS 3431 at 23 ± 1 °C
and 50 ± 2 % r.h. for not less than 24 h. Switch on the lamp and allow to develop full output. Adjust the
distance between the lamp and the test piece surface so that the UV incident light at the test piece surface
is 300 ± 20 "W/cm2 2).
A.3 Expression of results
Report the number of fluorescent spots with axes greater than 1 mm, and the presence or absence of
general fluorescence.
Appendix B
Method for determination of water repellency
B.1 Reagent
B.1.1 Dry indicator powder, prepared as follows.
Grind about 20 g of sucrose in a mortar and pass through a sieve of aperture size 75 "m complying with
BS 410.
Dry the powdered sucrose in a desiccator over silica gel. Weigh 10 g of dry sucrose and 0.01 g of dry sodium
fluorescein and mix thoroughly. Pass the mixture five times through a sieve of aperture size 75 "m
complying with BS 410, transfer to the powder dispenser and place in a desiccator, ready for use.
B.2 Apparatus
B.2.1 UV light source, with peak output at 366 nm. The luminous output of the lamp shall be such that the
required surface illumination of the test piece given in B.3 is obtained.
B.2.2 Flat dish, approximately 200 mm × 150 mm × 15 mm deep.
B.2.3 Desiccator.
B.2.4 Stopwatch.
B.2.5 Powder dispenser, consisting of a tube with a sieve of aperture size 150 "m complying with BS 410
at one end and closed at the other.
B.2.6 Thermometer, of convenient range and scale.
B.3 Procedure
Cut 10 test pieces from the paper, each 60 mm × 60 mm, and condition in accordance with BS 3431
at 23 ± 1 °C and 50 ± 2 % r.h. for not less than 24 h. Make two folds each 10 mm high at right angles along
two edges of five of the test pieces. Repeat the procedure for the remaining five test pieces with the other
side of the material on top.
Fill the flat dish to a depth of 10 mm with distilled or demineralized water at the conditioning temperature.
Switch on the UV lamp and allow it to develop full output. Adjust the distance between the lamp and the
water surface so that the UV incident light intensity at the water surface is 300 ± 20 "W/cm2. Sprinkle the
upper surface of a test piece thinly with indicator powder from the dispenser. Float the test piece on the
water under the UV light source and note the time taken for a general fluorescence to appear. Repeat the
procedure with nine further test pieces.

2) An instrument suitable for making this measurement is the Blak-Ray ultraviolet meter type J-221, available from Camlab
Ltd. Nuffield Road, Cambridge CB4 1TH.

© BSI 06-2001 3
BS 6256:1989

NOTE This test is considerably influenced by the water temperature. Precautions should be taken to ensure adherence to the
conditioning temperature requirements. In the case of prolonged testing it may be necessary to change the water periodically to
maintain this temperature.

B.4 Expression of results


Report the mean penetration time (in s) for each side of the paper.
Appendix C
Method for determination of methylene blue particulate penetration
C.1 Introduction
This test is based upon BS 2577 which contains sufficient detail to construct the apparatus and also
provides all relevant background information.
The apparatus used is that shown in BS 2577:1955 with the exception that the combined canister holder
(R) and the filter paper clamp (S) are replaced by the test piece holder (T) in which the test piece is clamped.
(See Figure 1 and Figure 2).
Clauses 6, 7 and 8 of BS 2577:1955 are not relevant to the testing of sterilization papers and are replaced
by the procedure given in this method.
All apparatus shall comply with BS 2577 except where otherwise stated.
C.2 Apparatus
NOTE Flowmeters of a commercially available type may be used as an alternative to those described in BS 2577 provided these are
obtained uncalibrated and then calibrated in situ as described in BS 2577.

C.2.1 Test cloud generator, comprising the atomizer (A), needle valve (V1), pressure gauge (D), compressed
air flowmeter (M1) and evaporation tube (E).
C.2.2 Control cock.
C.2.3 Test circuit, comprising test piece holder (T), test paper holder (F), flowmeter (M2) and control valve
(V2).
C.2.4 Bypass circuit, comprising the filter (G), flowmeter (M3) and control valve (V3).
C.2.5 Filter paper3).
C.2.6 Rotary suction pump.
C.2.7 Air drier.
C.3 Procedure
C.3.1 Calibration
Assemble the apparatus and calibrate the flowmeters in accordance with clause 5f) of BS 2577:1955. This
establishes the required flow rate settings at the working pressures in the test and bypass circuits.
C.3.2 Preliminary
Fill the atomizer with a 1 % methylene blue solution up to a level of 6 mm below that of the spray orifice:
approximately 500 mL of solution are required.
NOTE For information relating to the rate of consumption and replenishment of the solution, see Appendix Ba) of BS 2577:1955.

C.3.3 Start-up instructions


NOTE 1 Steps e) to h) establish the nominal air valve settings to give the required flow rates in subsequent operations. Minor
adjustments only from these settings should be needed.
Start up the apparatus as follows:
a) turn the control cock (C) to “OFF”;
b) switch on the suction pump;
c) close and clamp the unloaded test piece holder (T);

3) An Evans Adlard filter paper, grade FF6, is suitable.

4 © BSI 06-2001
BS 6256:1989

d) clamp the unloaded filter paper holder (F) firmly closed;


e) turn the control cock to “TEST”;
f) adjust the air valve (V2) to give a flow of 30 L/min through the bypass circuit;
g) turn the control cock to “OFF”;
h) adjust control valve (V3) to give a flow of 30 L/min through the test circuit;
i) turn on the compressed air to the atomizer and adjust the needle valve (V1) until the pressure gauge
(D) registers 205 kPa. The ball in the compressed air flowmeter (M1) should now rise to the calibration
mark. If the air flow is insufficient, turn off the compressed air and clear the atomizer jets.
NOTE 2 For details of maintenance, see Appendix B of BS 2577:1955.

C.3.4 Preparation of standard stains


Prepare the standard stains as follows:
a) close and clamp the unloaded test piece holder;
b) clamp a short piece of filter paper in the test paper holder;
c) turn the control cock to “TEST” for 20 s. During this period check, and adjust if necessary, the air valve
(V2) in the “test circuit” to give a flow rate of 30 L/min;
d) turn the control cock to “OFF”;
e) unclamp the test paper holder and discard the piece of filter paper;
f) insert and clamp in the test paper holder the end of a 300 mm length of filter paper;
g) turn the control cock to “TEST”, hold for 1 s and then turn to “OFF”.
h) unclamp the test paper holder, move the filter strip 25 mm to one side and reclamp;
i) repeat steps g) and h) but for 2 s duration;
j) repeat the sequence, increasing the duration of the run by 1 s on each up to 10 s;
k) remove the filter strip and expose it to a jet of steam until the intensity of the stains is fully developed.
This filter strip, with 10 stains of increasing intensity, is the standard test strip against which the test
stains are compared. The 1 s stain is equivalent to a 2.5 % penetration when the test is run for 40 s.
Successive stains represent increments of a 2.5 % penetration so that the 10 s stain corresponds to a 25 %
penetration.
C.3.5 Preparation of test stains
Prepare the test stains as follows:
a) cut two test pieces from the specimen to be tested, each 400 mm × 400 mm, and condition them in
accordance with BS 3431 at 23 ± 1 °C and 50 ± 2 % r.h. for not less than 24 h. Carry out the remainder
of the test within 10 min of removal of the test pieces from the conditioning atmosphere;
b) turn the control cock to “OFF”;
c) clamp a test piece into its holder such that the wire side is challenged by the test cloud;
d) clamp a short length of filter paper into the test paper holder;
e) turn the control cock to “TEST” and after 10 s turn to “OFF”. During this period check, and if necessary
adjust, the flow rate test circuit to 30 L/min;
f) discard the piece of filter paper and replace with a fresh piece;
g) turn the control cock to “TEST” and after 40 s turn to “OFF”;
h) remove the test piece and the piece of filter paper. Develop the stain on the filter paper using a jet of
steam;
i) repeat steps c) to h) using the other test piece and testing the other side of the paper.
Under the identical lighting conditions compare the test stains with the standard stains and visually match
them.

© BSI 06-2001 5
BS 6256:1989

C.4 Expression of results


Report the test results for each side of the paper in terms of percentage penetration.
C.5 Maintenance
For details of maintenance of the apparatus see Appendix B of BS 2577:1955.

Figure 1 — Circuit diagram of apparatus for methylene blue particulate penetration test

6 © BSI 06-2001
BS 6256:1989

Figure 2 — Test piece holder for methylene blue particulate penetration test

© BSI 06-2001 7
BS 6256:1989

Table 1 — Summary of performance requirements and test methods


Property Conditioning Test method BS 6256 Requirement
clause
reference
Grammage BS 3431 at 23 ± 1 °C
and 50 ± 2 % r.h. BS 3432 3.1 Not less than 56 g/m2
pH of water extract — BS 2924-1 3.2 Not less than 5 nor greater than 8
Chloride content
(calculated as sodium
chloride, NaCl) — BS 2924-4 3.3 Not more than 0.05 %
Sulphate content
(calculated as sodium
sulphate, Na2SO4). — BS 2924-3 3.4 Not more than 0.25 %
Fluorescence Not exhibit a general fluorescence
nor have more than 5 fluorescent
BS 3431 at 23 ± 1 °C spots each having an axis greater
and 50 ± 2 % r.h. Appendix A 3.5 than 1 mm
Bursting strength BS 3431 at 23 ± 1 °C
and 50 ± 2 % r.h. BS 3137 3.6 Not less than 230 kPa
Wet bursting strength BS 2922- 1
(10 min
— immersion) 3.7 Not less than 35 kPa
Tensile strength Not less than 4.67 kN/m machine
direction
BS 3431 at 23 ± 1 °C Not less than 2.33 kN/m cross
and 50 ± 2 % r.h. BS 4415 3.8 direction
Wet tensile strength Not less than 0.87 kN/m machine
BS 2922-2 direction
(1 min Not less than 0.43 kN/m cross
— immersion) 3.9 direction
Internal tearing Not less than 550 mN machine
resistance BS 4468 direction
BS 3431 at 23 ± 1 °C (single tear Not less than 550 mN cross
and 50 ± 2 % r.h. tester) 3.10 direction
Water repellency BS 3431 at 23 ± 1 °C
and 50 ± 2 % r.h. (not Penetration time not less
less than 24 h) Appendix B 3.11 than 20 s
Methylene blue BS 3431 at 23 ± 1 °C Appendix C
penetration and 50 ± 2 % r.h. (see also Not more than 20 % at a linear
(not less than 24 h) BS 2577) 3.12 air flow of 300 mm/min
Air permeance BS 3431 at 23 ±1 °C
(Bendtsen): medium and 50 ±2 % r.h. Not less than 3.4 "m/Pa·s at air
range (not less than 24 h) BS 6538-2 3.13 pressure of 1.47 kPa
Surface absorbency BS 2644 Surface absorbency of each
BS 3431 at 23 ± 1 °C (60 s surface shall be not more
and 50 ± 2 % r.h. exposure) 3.14 than 17 g/m2
Bendtsen roughness BS 3431 at 23 ± 1 °C Not greater than 350 mL/min on
and 50 ± 2 % r.h. BS 4420 3.15 one surface

8 © BSI 06-2001
BS 6256:1989

Publications referred to

BS 410, Specification for test sieves.


BS 2577, Methylene blue particulate test for respirator canisters.
BS 2644, Method for determination of water absorption of paper and board (Cobb method).
BS 2922, Strength of wet paper and board.
BS 2922-1, Method for determination of the bursting strength of paper and board after immersion in
water.
BS 2922-2, Method for determination of the tensile strength of paper and board after immersion in water.
BS 2924, Aqueous extracts of paper, board and pulp.
BS 2924-1, Method for determination of pH.
BS 2924-3, Method for determination of water-soluble sulphates (titrimetric method).
BS 2924-4, Method for determination of water-soluble chlorides (general method).
BS 3137, Methods for determining the bursting strength of paper and board.
BS 3203, Glossary of paper, board, pulp and related terms.
BS 3430, Method for sampling to determine the average quality of paper and board.
BS 3431, Method for the conditioning of paper and board for testing.
BS 3432, Method for determination of grammage of paper and board.
BS 4415, Determination of the tensile properties of paper and board.
BS 4415-2, Constant rate of elongation method.
BS 4420, Recommendations for the determination of the Bendtsen roughness of paper and board.
BS 4468, Method for the determination of the internal tearing resistance of paper.
BS 6257, Specification for paper bags for steam sterilization for medical use.
BS 6538, Air permeance of paper and board.
BS 6538-2, Method for determination of air permeance using the Bendtsen apparatus.
BS 6871, Specification for heat-sealable pouches and tube material converted from transparent plastics film
and paper for steam sterilization for medical use.

© BSI 06-2001
BS 6256:1989

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