1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23404-1 SANS 1043:2010Edition 3 SOUTH AFRICAN NATIONAL STANDARD The manufacture of sanitary towels Published by SABS Standards Division 1
4、Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 1043:2010 Edition 3 Table of changes Change No. Date Scope Foreword This South African standard was approved by National Committee SABS SC 1004K, Textiles Surgical dressings, i
5、n accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This document was published in March 2010. This document supersedes SABS 1043:1985 (edition 2, as amended by amdt 1:1994 and amdt 2:1999). SANS 1043:2010 Edition 3 1 Contents Page Forewo
6、rd 1 Scope . 3 2 Normative references . 3 3 Definitions . 3 4 Requirements . 4 4.1 General . 4 4.2 Construction . 4 4.3 Dimensions of filler components 4 4.4 Sanitary towel types and filler composition 5 4.5 Performance requirements . 5 4.6 Microbiological requirements . 6 4.7 Steriliity . 6 4.8 Aut
7、oclavability 6 5 Inspection and methods of test 6 5.1 Inspection . 6 5.2 Test specimens 7 5.3 Filler 7 5.4 Absorbency volume 7 5.5 Absorbency rate . 10 5.6 Microbiological examination . 11 5.7 Sterility 16 5.8 Autoclavability 16 6 Packing and marking 17 Annex A (normative) Notes to purchasers 18 Ann
8、ex B (informative) Quality verification of sanitary towels 18 Bibliography 18 SANS 1043:2010 Edition 3 2 This page is intentionally left blank SANS 1043:2010 Edition 3 3 The manufacture of sanitary towels 1 Scope This standard covers the manufacturing and performance requirements for four types of s
9、anitary towels for external use. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) ap
10、plies. Information on currently valid national and international standards can be obtained from the SABS Standards Division. 2.1 Standards SANS 70, Conditioning of textiles and standard temperate atmosphere for determing their physical and mechanical properties. SANS 81, Width of a textile fabric sa
11、mple. SANS 83, Length of a textile fabric sample. SANS 171, Glassware and equipment for microbiological tests. SANS 4833/ISO 4833, Microbiology of food and animal feeding stuffs Horizontal method for the enumeration of microorganisms Colony-count technique at 30 C. SANS 5553, Media and reagents for
12、microbiological tests. SANS 6888-2/ISO 6888-2, Microbiology of food and animal feeding stuffs Horizontal method for the enumeration of coagulase-positive staphylococci (Staphylococcus aureus and other species) Part 2: Technique using rabbit plasma fribinogen agar medium. 2.2 Other publications Unite
13、d States Pharmacopoeia (USP). 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 acceptable acceptable to the authority administering this standard, or to the parties concluding the purchase contract, as relevant SANS 1043:2010 Edition 3 4 3.2 extraneous dust atmos
14、pheric particulate matter that is produced from a source or sources other than any of the components used in the manufacture of sanitary towels 3.3 mechanical pulp papermaking pulp made entirely by mechanical means from various raw materials but usually from wood 4 Requirements 4.1 General 4.1.1 San
15、itary towels shall have been made in accordance with sound manufacturing practice, and shall be of an acceptable uniform make, shape and finish. 4.1.2 All sanitary towels shall be free from lumps, oil spots, streaks of dirt, and similar foreign matter that might affect their appearance or impair the
16、ir serviceability (or both). 4.1.3 Sanitary towels shall be delivered in a clean and commercially dry condition and shall, when so required, be capable of withstanding sterilization in an autoclave, or shall be individually sterile-packed. 4.2 Construction 4.2.1 Sanitary towels shall be rectangular
17、in shape (with or without wings) and shall consist of a filler (which may incorporate a non-absorbent layer) that is completely encased in a cover of a woven gauze or of a non-woven material or of a tubular knitted fabric (with or without a seam). 4.2.2 The cover in all sanitary towels shall be so s
18、ealed or secured that it cannot unwrap from the filler during normal handling and use. 4.2.3 If a sanitary towel has a non-absorbent face, this face shall be clearly indicated. 4.2.4 Regular and maternity sanitary towels shall be with or without loops, or shall have adhesive backing strips on the co
19、ver, as required. 4.2.5 Delivery sanitary towels shall be with or without loops, as required. 4.3 Dimensions of filler components The average length and width of the filler components, determined in accordance with 5.3, shall fall within the range of values given in table 1, appropriate to the size
20、designation of sanitary towels. SANS 1043:2010 Edition 3 5 Table 1 Dimensions of filler components Dimensions in millimetres 1 2 3 4 5 Size designation Dimensions “Thins“ Regular Maternity Delivery Lengtha 180 to 260 180 to 270 230 to 300 270 to 330 Width (of filler) 60 to 80 60 to 75 60 to 100 90 t
21、o 110 a The length of the absorbent component intended to be nearest to the body and excluding any non-absorbent or tissue wrappings. 4.4 Sanitary towel types and filler composition 4.4.1 Sanitary towels shall be of one of the types given in column 1 of table 2. 4.4.2 When determined in accordance w
22、ith 5.3.2, the filler composition shall comply with the appropriate requirements given in column 2 of table 2. 4.4.3 No component of the filler shall contain unprocessed waste paper or mechanical pulp. NOTE The filler may contain absorbent gelling agents. Table 2 Type designation and filler composit
23、ion 1 2 Type designation Filler composition COM A combination of cellulose pulp and cellulose tissue or cotton wool (or both) (or similar material(s) CP Cellulose pulp 4.5 Performance requirements Sanitary towels shall comply with the requirements given in table 3. SANS 1043:2010 Edition 3 6 Table 3
24、 Performance requirements 1 2 3 Property Requirement Test method subclause Absorbency volume (mL) 5.4 “Thins“ 15 min. Regular 5 min. Maternity 10 min. Delivery 20 min. Absorbency rate (s) 5.5 All sizes 10 max. 4.6 Microbiological requirements Sanitary towels that have not been sterile-packed (see 4.
25、1.3) shall be such that a) the total viable bacterial count, determined in accordance with 5.6.4.1, does not exceed 1 000 per gram of sanitary towel, and b) when tested in accordance with 5.6.4.2, 5.6.4.3 and 5.6.4.4, they shall be free from Enterobacteriaceae, Staphylococcus aureus and Pseudomonas
26、aeruginosa, respectively. 4.7 Sterility When sterile-packed sanitary towels are required, they shall pass the test for sterility given in 5.7. 4.8 Autoclavability When so required, and when tested in accordance with 5.8, sanitary towels shall be able to withstand steam sterilization without showing
27、any appreciable deterioration in handle or appearance. 5 Inspection and methods of test 5.1 Inspection After checking each package in the sample for compliance with the relevant requirements of clause 6, retain enough unopened packages for the microbiological tests, and then visually examine the con
28、tents of the remaining packages for compliance with the requirements given in 4.1 and 4.2. SANS 1043:2010 Edition 3 7 5.2 Test specimens 5.2.1 Physical tests Condition the test samples in accordance with SANS 70 and then take, at random, sufficient sanitary towels for each of the tests given in 5.3
29、to 5.5 (inclusive) and, when relevant, 5.8. 5.2.2 Microbiological tests From the packages retained in terms of 5.1, aseptically draw, at random, sufficient sanitary towels for the tests given in 5.6 and, when relevant, 5.7. 5.3 Filler 5.3.1 Dimensions of filler components 5.3.1.1 Remove the cover fr
30、om the sanitary towel under test. 5.3.1.2 Measure the width of the filler and the length of the appropriate absorbent component in accordance with SANS 81 and SANS 83, respectively, but take only one measurement in each direction (see table 1). 5.3.1.3 Record as the average length and average width
31、the arithmetic mean of the corresponding results on at least 10 sanitary towels. 5.3.1.4 Check for compliance with 4.3. 5.3.2 Filler composition 5.3.2.1 Determine the composition of the filler by microscopical examination and chemical analysis. 5.3.2.2 Check for compliance with 4.4. 5.4 Absorbency v
32、olume 5.4.1 Test solution Dissolve 2 g of Massons light green stain in 1 L of water at ambient temperature. 5.4.2 Apparatus 5.4.2.1 Electrodes The following electrodes made from woven copper wire gauze of aperture size approximately (2 2) mm, with each electrode having all cut edges so soldered as t
33、o cover the ends of the wires and with, soldered to an edge or corner, an insulated single-core conductor that has a jack plug connection at the free end: a) electrode A, of size (60 50) mm and with, cut from the centre, a square aperture with sides of length approximately 25 mm; b) electrodes B1 an
34、d B2, each of size (90 30) mm; c) electrode C, of size (100 50) mm; and SANS 1043:2010 Edition 3 8 d) electrodes D1 and D2, each of the shape and dimensions given in figure 1 and with, at the centre of the upper edge, a tag of size (20 15) mm that is perpendicular to the 20 mm wide surface of the el
35、ectrode. Dimensions in millimetres Key 1 R 50 2 tag 3 length of arc: 60 Figure 1 Electrodes D1 and D2 5.4.2.2 Cylinder 5.4.2.2.1 A hollow open-ended cylinder of a clear plastics material, with a nominal external diameter of 100 mm, a length of at least 120 mm, and two diametrically opposite holes, e
36、ach of diameter approximately 20 mm, at the midpoint of the length of the cylinder. 5.4.2.2.2 Electrode A is so attached to the cylinder that the square aperture is centred over one of the holes and the longer sides are parallel to the circumference of the cylinder. 5.4.2.2.3 Electrodes B1 and B2 ar
37、e also attached to the cylinder, each one 10 mm away from each end of the electrode A and with the longer sides parallel to the longitudinal axis of the cylinder. 5.4.2.2.4 The cylinder is permanently mounted (see figure 2) in a suitable frame (see 5.4.2.5) with the holes in vertical alignment and t
38、he hole that is surrounded by electrode A at the bottom. 5.4.2.3 Funnel A small glass funnel with a stem of length at least 100 mm and an internal bore of approximately 4 mm, and so suspended through the upper hole in the cylinder that the end of the stem just reaches the lower hole. 5.4.2.4 Reservo
39、ir A suitable reservoir (preferably of the constant-head type) mounted above the funnel, containing the test solution (see 5.4.1), and equipped with a tap or other suitable means for controlling the outflow of the solution into the funnel at a rate of (10 0,1) mL/min. SANS 1043:2010 Edition 3 9 Key
40、1 Tap or other suitable means 5 Hollow open-ended cylinder 2 Glass funnel 6 Electrodes 3 Frame 7 Mass piece 4 Pulley 8 Mirror Figure 2 Test rig 5.4.2.5 Supporting frame The frame is equipped with a) a means for wrapping the sanitary towel under test around the underside of the cylinder (with the san
41、itary towel centred below the lower hole) by attaching one end of the sanitary towel to a suitable anchor that is fixed to the side of the frame at a level not below the upper surface of the cylinder, and the other end of the sanitary towel to a cord that passes over a pulley that is secured to the
42、other side of the frame (at the same level as the anchor), and that carries a masspiece of approximately 250 g to apply tension to the sanitary towel; b) a means, similar to that described in 5.4.2.5(a), for holding the ends of electrode C so that its midpoint is in vertical alignment with the lower
43、 hole in the cylinder, its upper surface is in full contact with the lower surface of the sanitary towel under test, and that it is under the same tension as the sanitary towel; SANS 1043:2010 Edition 3 10 c) a means for holding each of electrodes D1 and D2 against each edge of the sanitary towel un
44、der test and centred on its transverse centre-line; and d) a mirror, so positioned and fixed to the base of the frame below the lower hole of the cylinder as to reflect the lower surface of the sanitary towel under test. 5.4.2.6 Relay box A suitable electrical relay box with a built-in transformer a
45、nd rectifier (for reducing voltage to 1 mV DC), that is connected to a mains supply, and that has six interconnected jack plug sockets to accommodate the connections from the electrodes, and is such that an electrical circuit made between any two of the electrodes by means of electrical conductance
46、through the test solution, is registered by a suitable signal lamp connected to each socket. 5.4.2.7 Balance A balance with a sensitivity of at least 0,1 g. 5.4.3 Procedure 5.4.3.1 Fill the reservoir with the test solution, weigh the sanitary towel under test to the nearest 0,1 g, and secure and ten
47、sion it as described in 5.4.2.5(a). 5.4.3.2 Secure and tension electrode C as described in 5.4.2.5(b), and position electrodes D1 and D2 (with the horizontal tags away from the sanitary towel) as described in 5.4.2.5(c). 5.4.3.3 Connect the jack plug from each electrode to the corresponding socket o
48、f the relay box and switch on the mains supply. 5.4.3.4 Run the test solution through the funnel at a rate of (10 0,1) mL/min until a signal lamp indicates that an electrical circuit has been made between two of the electrodes. 5.4.3.5 Close the tap from the reservoir, disconnect the mains supply to
49、 the electrodes, remove the sanitary towel and, using the dye in the test solution as an indicator, check the correct functioning of the electrode. 5.4.3.6 Reweigh the sanitary towel. 5.4.3.7 Repeat the test on at least a further nine sanitary towels. NOTE It is essential to ensure that all electrodes are always kept free from non-conductive matter. 5.4.4 Calculation 5.4.4.1 Calculate the mean gain in mass (in grams) of the sanitary towels tested and report this as the absorbency volume, in millilitres, of the sanitary towels. 5.4.4.2 Check for complian
