BS-6256-1989.pdf

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 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 Second edition February 1990 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 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 Amendments issued since publication Amd. No.Date of issueComments 10778June 2001Indicated by a sideline BS 6256:1989 © BSI 06-2001 i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Materials and manufacture1 3Performance1 4Sampling2 5Packaging2 6Marking of reels and outer packaging2 Appendix A Method for determination of fluorescence3 Appendix B Method for determination of water repellency3 Appendix C Method for determination of methylene blue particulate penetration4 Figure 1 Circuit diagram of apparatus for methylene blue particulate penetration test6 Figure 2 Test piece holder for methylene blue particulate penetration test7 Table 1 Summary of performance requirements and test methods8 Publications referred toInside back cover BS 6256:1989 ii© BSI 06-2001 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 It supersedes BS 6256:1982 which is withdrawn.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 BS 6256:1989 © BSI 06-2001 1 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. NOTEThe 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 NOTEA 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). BS 6256:1989 2© BSI 06-2001 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) suppliers 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 manufacturers 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. BS 6256:1989 © BSI 06-2001 3 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. BS 6256:1989 4© BSI 06-2001 NOTEThis 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 NOTEFlowmeters 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. NOTEFor 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 1Steps 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. BS 6256:1989 © BSI 06-2001 5 d) clamp the unloaded filter