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1、BRITISH STANDARD BS 6871:1989 Specification for Heat-sealable pouches and tube material converted from transparent plastics film and paper for steam sterilization for medical use Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6871:1989 T
2、his 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 02-1999 First published June 1987 First revision February 1990 The fo
3、llowing BSI references relate to the work on this standard: Committee reference PKM/566 Draft for comment 88/45732 DC ISBN 0 580 17672 X Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Packaging and Freight Containers Standards Policy Co
4、mmittee (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 Associati
5、on 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 Ind
6、ustry Association Amendments issued since publication Amd. No.Date of issueComments Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6871:1989 BSI 02-1999i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Material
7、s1 3Construction and design1 4Dimensions and tolerances1 5Performance1 6Marking2 7Packaging2 Appendix A Method for the determination of the strength of the heat-seal joint4 Appendix B Method for the determination of the wet strength of the heat-seal joint4 Appendix C Method for the determination of
8、resistance to high vacuum autoclaving4 Appendix D Method for the determination of freedom from pinholes5 Appendix E Method for the determination of fibre lay5 Figure 1 End/side view and cross section of typical gusseted pouch/tube material showing width dimensions to be quoted3 Publications referred
9、 toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6871:1989 ii BSI 02-1999 Foreword This revision of this British Standard has been prepared under the direction of the Packaging and Freight Containers Standards Policy C
10、ommittee at the request of the Sterilisation Packaging Materials Association. It supersedes BS 6871:1987 which is withdrawn. This edition revises 5.3, 5.4 and 5.6 of the previous edition and clarifies the procedure in Appendix E. Purchasers should state clearly in their orders whether they require g
11、usseted or non-gusseted tube or pouches and they should specify the dimensions that they require, as described in this British Standard. 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
12、. 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 6, an inside back cover and a back cover. This standard has been updated (see copyright date) and
13、may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6871:1989 BSI 02-19991 1 Scope This British Standard specifies requirements for
14、 materials, construction, performance, marking and packaging for heat-sealable pouches and tube material, which have been converted from plastics film and paper, and are to be used to contain medical items to be steam sterilized. NOTEThe titles of the publications referred to in this standard are li
15、sted on the inside back cover. 2 Materials 2.1 The pouches and tube material shall be manufactured from paper complying with BS 6256 and plastics film complying with 2.2 and 2.3 (see 3.1.1). 2.2 The plastics film shall be: a) a transparent composite of two or more layers; b) of materials recognized
16、as non-toxic; c) free from foreign matter and/or imperfections which would adversely affect the performance of the finished product when tested in accordance with clause 5; d) heat sealable to the paper by means of impulse, heated jaw or rotary action heat sealers. NOTETypical heat sealing procedure
17、s involve a dwell time of 1 s at 175 C to 200 C at a pressure within the range 275 kPa to 170 kPa; lower temperatures are used in conjunction with higher pressures. 2.3 The breaking factor of the plastics film shall be not less than 25 N per 15 mm when tested in accordance with ASTM D 882-88 (method
18、 A)1). 3 Construction and design 3.1 Construction 3.1.1 Pouches and tube material shall be constructed from one layer of paper and one layer of plastics composite film, heat-sealed together along their lengthwise edges and pouches shall in addition be heat-sealed across the width at one end. 3.1.2 T
19、he overall width of the heat-seals shall be not less than 6 mm. 3.2 Design 3.2.1 Pouches shall be provided with sufficient space between the top and the widthwise heat-seal to enable the two webs of material to be separated and peeled apart with ease. NOTEThe side seals may be extended past the widt
20、hwise heat-seal towards the top corners of the “peel open area” of the pouch in such a way that peelability is not impaired but a measure of protection against the entry of dirt is provided. 3.2.2 If pouches are provided with thumb cuts at the top and bottom as opening and filling aids, the depth of
21、 such thumb cuts shall not exceed 12 mm. 4 Dimensions and tolerances For ordering and package marking purposes, external dimensions shall be quoted as follows. The tolerances on the stated dimensions, other than total tube length, shall be 3 mm. 5 Performance 5.1 Strength of the heat-seal joint When
22、 tested as described in Appendix A, both before and after autoclaving in accordance with C.2, the strength of the heat-seal joints (see 3.1) shall be not less than 1.5 N per 15 mm width. 5.2 Wet strength of the heat-seal joint When tested as described in Appendix B, both before and after autoclaving
23、 in accordance with C.2, the wet strength of the heat-seal joints shall be not less than 1.2 N per 15 mm width. 5.3 Ability to withstand high vacuum autoclaving When tested as described in Appendix C, the sealed pouch or tube shall not burst nor shall any plastics interply bond separate or become cl
24、oudy. The heat-seal shall cover the total length and the full width of the individual heat-seal lines and there shall be no splitting of the paper more than 10 mm from the heat-seal lines. 5.4 Print performance When tested as described in Appendix C, there shall be no visible evidence of ink penetra
25、tion through the paper. 1) American Society for Testing and Materials standards may be purchased from Enquiry Section, BSI, Linford Wood, Milton Keynes, MK 14 6LE. Pouches, ungusseted Overall width and length Pouches, gusseted (see Figure 1) Width of plastics face/paper back Width of gusset (outer g
26、usset fold to inner gusset fold 2) Length Tube material, ungusseted Overall width Total length Tube material, gusseted Width of plastics face/paper back Width of gusset (outer gusset fold to inner gusset fold 2) Total length Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2
27、006, Uncontrolled Copy, (c) BSI BS 6871:1989 2 BSI 02-1999 5.5 Steam sterilization indicator The steam sterilization indicator shall be sensitive to a recognized steam autoclave process and the colour change shall be to brown. 5.6 Freedom of plastics composite film from pinholes When tested as descr
28、ibed in Appendix D, there shall be no staining of the paper layer. 6 Marking 6.1 Pouches and tube material shall be printed with the following. a) The words “Do not use if the pack is damaged”. b) The manufacturers name or trade-mark. c) A reference number from which it shall be possible to trace th
29、e manufacturing history of the pouch or tube material. d) A steam sterilization process indicator. On pouches the markings shall be printed on the outside and/or the inside face of the paper, provided that on the outside face a single rectangular area, not less than 50 % of the total face area, is l
30、eft free from print and that all print on the inside face is within the “peel open area” described in 3.2.1. On tube material the markings shall be printed on the outside face of the paper only, either at intervals along the length with a rectangular area 50 mm 50 mm free from print within each prin
31、t repeat, or continuously down the length with not less than 50 % of the face width free from print. NOTEIt is essential that sufficient space is left to enable the user to label the contents clearly. The requirements specified for areas free from print on the outside face should be considered minim
32、um requirements. 6.2 All printing shall be on the paper layer only. 6.3 Pouches shall be marked with the direction of peel. 6.4 Tube material on which the lengthwise heat-seal is parallel with the machine direction of the paper shall be marked to indicate the direction of peel which ensures least fi
33、bre disturbance. NOTEThis may be determined by using the method given in Appendix E. 6.5 The shelf container or inner package for the pouches or tube material shall be marked with the following. a) A description of contents (including the number and date of this British Standard, i.e. BS 6871:19892)
34、 and designation or size. b) The quantity in the container or package. c) The manufacturers or suppliers name and/or trademark. d) The batch number and date of manufacture. e) The recommended storage conditions. 7 Packaging The pouches or tube material shall be packed in trade packages of a type nor
35、mally used for commercial deliveries of packaging for medical use within the United Kingdom or overseas according to the location of the consignee. Each trade package shall be legibly and durably marked with the information listed in 6.5 a) to e). 2) Marking BS 6871:1989 on or in relation to a produ
36、ct 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
37、 with third party certification of conformity which may also be desirable. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6871:1989 BSI 02-19993 Figure 1 End/side view and cross section of typical gusseted pouch/tube material showing wid
38、th dimensions to be quoted Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6871:1989 4 BSI 02-1999 Appendix A Method for the determination of the strength of the heat-seal joint A.1 Apparatus A.1.1 Tensile tester, capable of acting on the
39、 test piece at a rate of jaw separation of 200 10 mm/min, and permitting the tensile force at the moment of failure to be read to an accuracy of 1 %. A.2 Non-autoclaved pouches and tube material A.2.1 Preparation of test pieces Cut five strips, each 15 0.1 mm wide, from the pouch or tube material, a
40、t right angles to the heat-seal joint such that the total length of each strip is not less than 40 mm with the heat-seal joint at approximately the mid-point. NOTEIn the case of pouches the test pieces should be representative of all the manufacturers heat-seal joints. A.2.2 Procedure Clamp the free
41、 end of the plastics film section of a test piece in one jaw of the apparatus and the free end of the paper section in the other jaw, with the tail unsupported. Peel the sealed interface apart at a rate of separation of 200 10 mm/min, and record the maximum force at break in newtons. Repeat with the
42、 other test pieces. A.3 Autoclaved pouches and tube material Prepare five strips as described in A.2.1 from a pouch or tube which has undergone autoclaving in accordance with C.2 and test them as described in A.2.2. A.4 Expression of results Report the heat-seal strength of each test piece in newton
43、s per 15 mm. Appendix B Method for the determination of the wet strength of the heat-seal joint B.1 Apparatus The apparatus shall be as specified in A.1. B.2 Non-autoclaved pouches and tube material B.2.1 Preparation of test pieces Prepare the test pieces as described in A.2. B.2.2 Procedure Immerse
44、 the centre portion of a test piece in distilled or demineralized water at 23 2 C. Ensure that the heat-seal joint is at the centre of the wetted portion. Hold the test piece in this position for 1 min, withdraw it and touch each side against a pad of absorbent paper to remove any drops of water. Th
45、en proceed as described in A.2.2. Repeat the wetting and test procedure with the other test pieces. B.3 Autoclaved pouches and tube material Prepare five strips as described in A.2.1 from a pouch or tube material which has undergone autoclaving in accordance with C.2 and test them as described in B.
46、2.2. B.4 Expression of results Report the heat-seal strength of each test piece in newtons per 15 mm. Appendix C Method for the determination of resistance to high vacuum autoclaving C.1 Preparation of test specimens Take 10 pouches or 300 mm lengths of tube material and insert into each sufficient
47、absorbent cotton gauze B.P. to fill approximately two-thirds of the maximum volume. Seal the test specimens using an impulse, heated jaw or rotary action heat sealer. C.2 Procedure Place the test specimens in a sterilizer then carry out the following sequence. a) Air removal stage. Steam flush or mu
48、ltipulse the system to remove any air. b) Sterilization stage. Increase the steam pressure to 220 kPa (32 lb/in2) (134 C) and maintain the pressure for not less than 3 min. c) Drying stage. Remove the steam by vacuum. Maintain the vacuum to dry the load. d) Air admission stage. Increase the pressure
49、 to atmospheric pressure by the admission of air. The total sequence shall not exceed 35 min. On completion of this sequence examine the test specimens for bursts and/or separation of the plastics interply bonds. Examine also the heat-seal strips by slowly and carefully peeling the heat-seal joints apart by hand. When peeled apart, the plastics film will display a matt surface where the heat-seal is effective but will show a glossy surface where the heat-seal is not satisfactory. +4 0 Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:
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