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1、BRITISH STANDARD BS 6257:1989 Specification for Paper bags for steam sterilization for medical use UDC 676.24:621.798.156:615.4:006.3/.8 Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6257:1989 This British Standard, having been prepared
2、 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 30 March 1990 BSI 03-1999 First published September 1982 Second edition March 1990 The following BSI references relate to the work o
3、n this standard: Committee reference PKM/566 Draft for comment 88/45392 DC ISBN 0 580 18013 1 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/
4、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 Indus
5、trial 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
6、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 6257:1989 BSI 03-1999i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Materials1 3Construction and design1 4Dimensions a
7、nd tolerances1 5Performance1 6Marking2 7Packaging2 Appendix A Method for determination of pH, chlorides and sulphates3 Appendix B Method for assessing the strength performance of the back seam joint3 Appendix C Method for determination of wet tensile strength of back seam joint3 Appendix D Method fo
8、r determination of resistance to autoclaving3 Appendix E Guidance notes on size of sterilization bags4 Figure 1 Typical, unlipped, plain top bag with thumb cut5 Figure 2 Typical, unlipped, heat-seal adhesive closure bag with thumb cut6 Figure 3 Typical, lipped, plain top bag7 Figure 4 Typical lipped
9、, heat-seal closure bag8 Table 1 Designation, dimensions and codes for paper sterilization bags4 Table 2 Summary of performance requirements and test methods6 Publications referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy,
10、(c) BSI BS 6257:1989 ii BSI 03-1999 Foreword This revision of BS 6257 has been prepared under the direction of the Packaging and Freight Container Standards Policy Committee, at the request of the Sterilization Packaging Materials Association. It supersedes BS 6257:1982 which is withdrawn. The princ
11、ipal changes from the previous edition are as follows: a) the standard includes gusseted and non-gusseted bags; b) dimensional tolerances are consistent irrespective of the bag size; c) a greater latitude is allowed in positioning the heat-seal strip closure; d) for lipped bags, the lip depth is spe
12、cified; e) the colour change for the steam sterilization indicator is now a requirement; f) changes to the marking requirements. 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. Compli
13、ance 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. This standard has been updated (see copyright date) and may have
14、 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 6257:1989 BSI 03-19991 1 Scope This British Standard specifies requirements for materia
15、ls, construction, performance, packaging and marking for single web, paper sterilization bags for steam sterilized dressings, instruments, or other items of medical equipment. Non-heat-seal closure and heat-seal closure bags are covered by the standard. NOTEThe titles of the publications referred to
16、 in this standard are listed on the inside back cover. 2 Materials The bags shall be manufactured from paper complying with BS 6256. Only materials recognized by the appropriate authority1) as non toxic shall be used in the manufacture of the bags. 3 Construction and design 3.1 Construction The bags
17、 shall be manufactured from single web paper. 3.2 Design Bags shall be of the following designs: a) unlipped, plain top with thumb cut (see Figure 1); b) unlipped, heat seal closure with thumb cut (see Figure 2); c) lipped, plain top (see Figure 3); d) lipped, heat seal closure (see Figure 4); e) gu
18、sseted or non-gusseted. NOTE“Plain top” in this context means non-heat-seal closure. 3.3 Bottom seal formation The bottom seal formation shall be one of the following types: a) double folded with each fold bonded with a suitable non-corrosive adhesive; b) sealed across the entire width of the bottom
19、 of the bag by means of a heat-seal or other suitable non-corrosive adhesive bond, not less than 6.5 mm in depth; c) sealed across the entire width of the bottom of the bag by means of a heat-seal or other suitable non-corrosive adhesive bond, and then folded once or more, each fold being bonded wit
20、h a suitable non-corrosive adhesive or heat-sealed. 3.4 Back seam The seam shall be made at the back with a double line of water resistant non-corrosive adhesive. 4 Dimensions and tolerances 4.1 Dimensions For ordering and package marking purposes dimensions shall be quoted in the following order: a
21、) gusseted bags: width, gusset, length; b) non-gusseted bags: width, length. NOTE 1The length measurement is internal and is from the bottom of the bag to the top of the lip or thumb cut. NOTE 2Where the bag has a serrated cut-off the measurements are taken from the bottom of the serration. 4.2 Tole
22、rances on dimensions The tolerances on the stated dimensions shall be as follows: a) bag widths 3 mm; b) bag gussets 3 mm; c) bag lengths 10 mm. 4.3 Heat-seal strip For bags with a heat-seal closure the heat-seal adhesive shall be applied as a continuous horizontal strip across the front, gussets (i
23、f gusseted) and back of the bag. The width of the heat-seal strip shall be 25 3 mm on bags 150 mm or less in width, and 40 3 mm on bags wider than 150 mm. The top edge of the heat-seal strip shall be positioned not less than 2 mm and not more than 10 mm from the lower lip or bottom of the thumb cut.
24、 4.4 Thumb cut Unlipped bags shall incorporate a thumb cut 9 3 mm deep and not less than 15 mm wide for ease of opening. 4.5 Lip Lipped bags up to and including 500 mm in length shall have a lip not greater than 20 mm deep. Lipped bags over 500 mm in length shall have a lip not greater than 25 mm de
25、ep. 5 Performance NOTEA summary of performance requirements and test methods is given in Table 2. 5.1 pH of the water extract The pH of the water extract of the paper and adhesive sandwich shall be not less than 4.5 and not greater than 8.0 when tested in accordance with Appendix A. 5.2 Chloride con
26、tent The chloride content of the paper and adhesive sandwich, calculated as sodium chloride (NaCl), shall not exceed 0.05 % when tested in accordance with Appendix A. 1) For further information contact Enquiry Section at BSI, Linford Wood, Milton Keynes MK14 6LE. Licensed Copy: sheffieldun sheffield
27、un, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6257:1989 2 BSI 03-1999 5.3 Sulphate content The sulphate content of the paper and adhesive sandwich, calculated as sodium sulphate (Na2SO4), shall not exceed 0.25 % when tested in accordance with Appendix A. 5.4 Tensile stren
28、gth of the back seam joint The tensile strength of the back seam joint shall be not less than 2.33 kN/m width, when tested in accordance with Appendix B. 5.5 Wet tensile strength of the back seam joint The wet tensile strength of the back seam joint shall be not less than 0.43 kN/m width when tested
29、 in accordance with Appendix C. 5.6 Resistance to autoclaving The bag shall not burst when tested in accordance with Appendix D in a porous load sterilizer. 5.7 Steam sterilization indicator The steam sterilization indicator shall be sensitive to a recognized steam autoclave process and the colour c
30、hange shall be to brown. 6 Marking 6.1 All bags shall be marked with the following minimum information: a) wording on the front face of the bag to indicate that the bag must not be used if the seal is broken or the pack is damaged; b) the manufacturers or suppliers name or trade mark, on the back fa
31、ce of the bag; c) a reference number from which it shall be possible to trace the manufacturing history of the bag. 6.2 Where a steam sterilization process indicator is required it shall not be less than 350 mm2 in area, on the front face of the bag. Wording that describes the final colour of the in
32、dicator after sterilization shall be positioned immediately adjacent to the indicator. NOTEBags may have additional marking as agreed between supplier and customer. 7 Packaging The bags shall be packed in trade packages of a type normally used for commercial deliveries of medical packaging within th
33、e United Kingdom or overseas according to the location of the consignee. Each trade package shall be legibly and durably marked with the following information: a) description of contents (including, as appropriate, BS 6257:19892), a code or size); b) quantity in package; c) manufacturers or supplier
34、s name or trademark; d) date of manufacture; e) batch number; f) the recommended storage conditions. 2) Marking BS 6257:1989 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 o
35、f 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. Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:0
36、0 2006, Uncontrolled Copy, (c) BSI BS 6257:1989 BSI 03-19993 Appendix A Method for determination of pH, chlorides and sulphates A.1 Preparation of test pieces From the bag(s) cut specimens so that in each case the joint and a 10 mm width of paper on either side of the joint is included. Take a suffi
37、cient number of these specimens to weigh 10 g and cut these into square pieces approximately 10 mm 10 mm. A.2 Procedure Determine pH by the method described in BS 2924-1, chlorides and sulphates by the methods described in BS 2924-3 and BS 2924-4. A.3 Expression of results Report the following infor
38、mation: a) the pH of the specimen to the nearest 0.1 pH unit; b) the percentage of sodium chloride (NaCl) in the extract, to two significant figures; c) the percentage of sodium sulphate (Na2SO4) in the extract, to two significant figures. Appendix B Method for assessing the strength performance of
39、the back seam joint B.1 Principle Tensile stress is applied at right angles to a joint in a test piece until failure occurs. B.2 Preparation of test pieces Cut 10 strips, each 15 mm wide, from the bag(s) at right angles to the joint, such that a length of 15 mm of the joint is in the centre of each
40、strip. B.3 Procedure Carry out the test in accordance with clause 9 of BS 4415-2:1986, except that it is not necessary to condition the sample or carry out the test in a conditioned atmosphere. If the paper fails before the specified value is achieved, the seam has not been tested and the test is in
41、valid and the reason for this shall be investigated. NOTE 1Where the size of the bag prevents compliance with 180 mm or 100 mm test lengths, 50 mm test lengths should be used. NOTE 2It is important to avoid inclusion of creases in the test length. B.4 Expression of results Report the mean tensile st
42、rength (in kN/m width) to three significant figures. Appendix C Method for determination of wet tensile strength of back seam joint C.1 Preparation of test pieces Cut 10 strips, 15 mm wide, from the bag(s) at right angles to the joint, such that a length of 15 mm of the joint is in the centre of eac
43、h strip. C.2 Procedure Carry out the procedure as specified in BS 2922-2 except that a soaking time of 60 5 s is to be used. It is not necessary to condition the sample prior to soaking. C.3 Expression of results Report the mean wet tensile strength (in kN/m width) to two significant figures. Append
44、ix D Method for determination of resistance to autoclaving D.1 Preparation of test specimens Take 10 bags and insert into each sufficient absorbent cotton gauze B.P. to fill the bags without stressing the seals. Seal the bags using the heat-seal adhesive strip where applicable or by sealing with a s
45、uitable autoclave tape that remains fully adherent under the conditions of the test. D.2 Procedure Place test specimens in a sterilizer then carry out the following sequence: a) Air removal stage. By means of steam flushing or multipulsing system. b) Sterilizing stage. Increase steam pressure to 220
46、 kPa (32 lb/in2) 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 to atmospheric pressure by the admission of air. The total sequence shall not exceed 35 min. D.3 Express
47、ion of results Record the number of bags that burst (if any). 134 +4 0 C Licensed Copy: sheffieldun sheffieldun, na, Tue Dec 05 01:26:58 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 6257:1989 4 BSI 03-1999 Appendix E Guidance notes on size of sterilization bags Whilst the standard includes toleranc
48、es for bag size dimensions, it does not specify bag size or make any recommendations. In practice, both plain and gusseted bags with or without heat-seal closure are available in a wide range of sizes. However, a number of bag codes and/or sizes are in general use. These are listed in Table 1 for co
49、nvenience. It is stressed that this list is not a preferred or recommended list and that many other sizes are available from manufacturers. Table 1 Designation, dimensions and codes for paper sterilization bags CodeWidthGussetLength mmmmmm A9050125 or 150 B9050250 C11030190 D14075250 E19065250 F14050330 H18095380 J10050150 K15025330 L or M34250100380 M30075530 N300125610 O18075530 P19065330 Q11045190 R12550250 S12590230 T380125510 U7525480 V12525150 W12550560 T 35609 M 35380125or M 36610 M 190125 or 150 M 290230 M 3125146 or 150 Lic
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