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 978-0-626-23632-8 SANS 446:2010Edition 4.1SOUTH AFRICAN NATIONAL STANDARD Absorbent gauze (fabric and swabs) and butter muslin Published by SABS Sta
4、ndards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 446:2010 Edition 4.1 Table of changes Change No. Date Scope Amdt 1 2010 Amended to update a referenced standard. Foreword This South African standard was appr
5、oved by National Committee SABS SC 1004K Textiles Surgical dressings, in 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 SANS 446:2006 (edition 4). Annex A forms an int
6、egral part of this standard. Annex B is for information only. A vertical line in the margin shows where the text has been technically modified by amendment No. 1. SANS 446:2010 Edition 4.1 1 Contents Page Foreword 1 Scope . 3 2 Normative references . 3 3 Definitions 4 4 Requirements . 4 5 Sampling l
7、evels 7 6 Inspection and methods of test 7 6.1 Inspection 7 6.2 Conditioning 8 6.3 Colour and colour match of dyed swabs . 8 6.4 Fibre composition 8 6.5 Weave . 8 6.6 Number of threads per 10 cm . 8 6.7 Mass per area . 8 6.8 Absorption rate 8 6.9 Non-fibrous material content . 8 6.10 Ash content . 8
8、 6.11 Fluorescence . 8 6.12 Acidity 8 6.13 Alkalinity 8 6.14 Colour fastness of dyed swabs . 9 6.15 X-ray opacity . 10 6.16 Sterility . 10 7 Packing and marking . 10 Annex A (normative) Notes to purchasers . 13 Annex B (informative) Quality verification of absorbent gauze (fabric and swabs) and butt
9、er muslin 14 Bibliography 14 SANS 446:2010 Edition 4.1 2 This page is intentionally left blank SANS 446:2010 Edition 4.1 3 Absorbent gauze (fabric and swabs) and butter muslin 1 Scope This standard specifies requirements for the manufacture of three types of absorbent gauze and one type of butter mu
10、slin. 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) applies. Information on curre
11、ntly valid national and international standards can be obtained from the SABS Standards Division. AATCC test method 20, Fiber analysis: Qualitative. Available from World Wide Web SANS 70, Conditioning of textiles and standard temperate atmosphere for determining their physical and mechanical propert
12、ies. SANS 79, Textiles Mass per unit area of conditioned fabrics. SANS 81, Width of a textile fabric sample. SANS 82, Width of a textile fabric in a piece or roll. SANS 83, Length of a textile fabric sample. SANS 84, Length of fabric in a piece or roll. SANS 105-A01/ISO 105-A01, Textiles Tests for c
13、olour fastness Part A01: General principles of testing. SANS 105-A02/ISO 105-A02, Textiles Tests for colour fastness Part A02: Grey scale for assessing change in colour. SANS 105-A03/ISO 105-A03, Textiles Tests for colour fastness Part A03: Grey scale for assessing staining. SANS 105-F02/ISO 105-F02
14、, Textiles Test for colour fastness Part F02: Specification for cotton and viscose adjacent fabrics. Amdt 1 SANS 446:2010 Edition 4.1 4 SANS 977, Textile tolerances. SANS 5003 (SABS SM 3), Sterility of solid materials. SANS 5114, Non-fibrous material content of textiles (method using starch-digestin
15、g enzymes). SANS 5254, Determination of the presence of alkalinity in surgical dressings. SANS 5255, Determination of the presence of acidity in surgical dressings. SANS 5257, Ash content of textile surgical dressings. SANS 5263, Water absorption rate of textile fabrics. SANS 7211-2/ISO 7211-2, Text
16、iles Woven fabrics Construction Methods of analysis Part 2: Determination of number of threads per unit length. SANS 10004, Terms and definitions for textiles and textile merchandise. 3 Definitions For the purposes of this document, the terms and definitions given in SANS 10004 and the following app
17、ly. acceptable acceptable to the authority administering this standard, or to the parties concluding the purchase contract, as relevant 4 Requirements 4.1 General 4.1.1 Fabric When visually examined in accordance with 6.1.1, the fabric shall a) be an absorbent gauze or butter muslin as required (see
18、 annex A), made in accordance with sound manufacturing practice from clean and evenly spun cotton yarns; b) be bleached to an acceptable white colour; c) be of acceptably uniform make and width; d) be free from defects that affect its appearance, or that might impair its serviceability, or both; e)
19、when so required (see annex A) contain an X-ray-detectable component that consists of a distinctly coloured continuous monofilament or multifilament yarn that is heat-sealed to, or woven into, the fabric and that contains at least 55 % of barium sulfate or a suitable percentage of another acceptable
20、 material that provides a comparable X-ray opacity; and f) be in a clean and commercially dry condition when packed. SANS 446:2010 Edition 4.1 5 4.1.2 Gauze swabs When visually examined in accordance with 6.1.2, the gauze swabs shall a) be of the type of absorbent gauze fabric required (see table 1
21、and annex A); b) be manufactured so that no cut edges are visible; c) be bleached or dyed, as required (see annex A); d) in the case of bleached swabs, and when so required (see annex A), contain an X-ray-detectable component as specified in 4.1.1(e); and e) be in a clean and commercially dry condit
22、ion when packed. 4.2 Width of fabric The width of the fabric, determined in accordance with 6.1.1, shall be 90 cm or 150 cm, as specified by the purchaser (see annex A), subject to the relevant tolerances laid down in SANS 977. 4.3 Length of fabric The absorbent gauze or butter muslin in a package s
23、hall be in one continuous length. The length, determined in accordance with 6.1.1, shall be 1 m, 5 m, 10 m or 100 m, as specified by the purchaser (see annex A), subject to the relevant tolerances laid down in SANS 977. 4.4 Colour and colour match of dyed swabs 4.4.1 When dyed swabs are required, th
24、ey shall be dyed with a suitable non-toxic dye and shall be of the colour required (see annex A). 4.4.2 When dyed swabs are tested in accordance with 6.3, any difference between the required colour and that of the dyed swabs shall not exceed the difference represented by a grade 3-4 of the grey scal
25、e for assessing change in colour (see SANS 105-A02). 4.5 Fabric The fabric (including that of a swab) shall comply with the requirements given in table 1, appropriate to the type. When the fabric is visually examined in accordance with 6.1.1 and 6.1.2, the weave shall be plain. SANS 446:2010 Edition
26、 4.1 6 Table 1 Fabric requirements 1 2 3 4 5 6 Requirement Absorbent gauze Butter muslin Property Type 1 Type 2 Type 3 Type 1 Test method subclause Fibre composition . All cotton 6.4 Weave Plain 6.5 Number of threads per 10 cm, min. 6.6 Warp . Weft 62 38 41 27 65 45 171 108 Mass per area, g/m2, min.
27、 10 7 15 32 6.7 Absorption rate, s, max. 10 6.8 Non-fibrous material content, %, max. 1 6.9 Ash content, %, max. 0,5 6.10 Fluorescence . Not more than an occasional point of intense blue fluorescence shall be visible 6.11 Acidity No distinct yellow colour shall develop 6.12 Alkalinity No distinct pi
28、nk colour shall develop 6.13 Colour fastness of dyed swabs, rating, min. 6.14 Change in colour . Staining of transfer cloths . 4-5 4-5 4-5 4-5 4-5 4-5 4.6 Size and number of plies of gauze swabs Unless otherwise required (see annex A), and when measured in accordance with 6.1.2, the nominal size of
29、and the number of plies in the swabs shall be one of the combinations given in columns 1 and 2 of table 2, and the unfolded area of a swab shall be equal to the appropriate value given in column 3 of table 2. SANS 446:2010 Edition 4.1 7 Table 2 Nominal size, number of plies, and unfolded area of swa
30、bs 1 2 3 Nominal size Number of plies Unfolded area of a swabamm cm250 50 75 75 75 75 8 8 12 200 450 675 100 100 100 100 100 100 100 100 8 12 16 32 800 1 200 1 600 3 200 a Subject to a tolerance of 15 %. 4.7 X-ray opacity When X-ray-detectable absorbent gauze fabric or swabs are tested in accordance
31、 with 6.15, the X-ray-detectable component shall be clearly visible on the developed radiographic film. 4.8 Sterility When sterile-packed swabs (see 7.1.2) are required, they shall pass the test for sterility given in 6.16. 5 Sampling levels Sampling levels for testing and inspection shall be establ
32、ished by the responsible testing authority and the manufacturer to assure a reasonable and acceptable reliability at a reasonable and acceptable confidence level, and to ensure that absorbent gauze and butter muslin certified as being compliant with this standard are compliant. Information on the qu
33、ality verification of absorbent gauze and butter muslin is given in annex B. 6 Inspection and methods of test 6.1 Inspection 6.1.1 Fabric After checking each package for compliance with the relevant requirements of clause 7, visually examine and measure the contents for compliance with 4.1.1, 4.2, 4
34、.3 and 4.5 (weave only), using SANS 82 and SANS 84 to determine the width and length, respectively. 6.1.2 Gauze swabs After checking each package for compliance with the relevant requirements of clause 7, visually examine and measure the contents for compliance with 4.1.2, 4.5 (weave only) and 4.6,
35、using SANS 81 and SANS 83 to determine the width, length, and unfolded area of the swab. SANS 446:2010 Edition 4.1 8 6.2 Conditioning Condition each laboratory sample in accordance with SANS 70 and then take from each the test specimens required for the tests given in 6.3 to 6.16 (inclusive). 6.3 Co
36、lour and colour match of dyed swabs Use SANS 105-A02. Check for compliance with 4.4.2. 6.4 Fibre composition Use AATCC test method 20. Check for compliance with table 1. 6.5 Weave Determine by visual and physical examination. Check for compliance with table 1. 6.6 Number of threads per 10 cm Use SAN
37、S 7211-2. Check for compliance with table 1. 6.7 Mass per area Use SANS 79 on test specimens of full width. Check for compliance with table 1. 6.8 Absorption rate Use SANS 5263 and, in the case of swabs, use five folded swabs as test specimens. Check for compliance with table 1. 6.9 Non-fibrous mate
38、rial content Use SANS 5114. Check for compliance with table 1. 6.10 Ash content Use SANS 5257. Check for compliance with table 1. 6.11 Fluorescence Examine, under a screened ultraviolet light that has a maximum output at a wavelength of 365 nm, a 2-ply layer of the fabric under test and, in the case
39、 of swabs, swabs that have been unfolded to a 2-ply layer. Check for compliance with table 1. 6.12 Acidity Use SANS 5255. Check for compliance with table 1. 6.13 Alkalinity Use SANS 5254. Check for compliance with table 1. SANS 446:2010 Edition 4.1 9 6.14 Colour fastness of dyed swabs 6.14.1 Apparat
40、us and reagents 6.14.1.1 Two cotton adjacent fabrics, each of size approximately 50 mm 50 mm, that comply with the relevant requirements of SANS 105-F02. Amdt 16.14.1.2 Analytically pure ethanol, made up to a 70 % volume fraction. 6.14.1.3 Flat-bottomed dish, of suitable size. 6.14.1.4 Glass plate,
41、of size approximately 50 mm 50 mm and of mass approximately 50 g. 6.14.1.5 Forced-draught oven, maintained at 37 C 1 C. 6.14.1.6 Grey scales, for assessing change in colour and staining as specified in SANS 105-A02 and SANS 105-A03, respectively. 6.14.2 Preparation of test specimens 6.14.2.1 From th
42、e dyed swabs under test, cut eight pieces, each of size approximately 50 mm 50 mm and superimpose each piece, one on top of the other, to form an 8-ply test specimen. 6.14.2.2 Place the test specimen between the two cotton adjacent fabrics (see 6.14.1.1) and sew along one side to form a composite te
43、st specimen. 6.14.3 Procedure 6.14.3.1 Saturate the composite test specimen (see 6.14.2.2) with the ethanol (see 6.14.1.2). 6.14.3.2 Lay the composite test specimen smoothly in the dish (see 6.14.1.3) and add enough of the ethanol to cover the composite test specimen completely. 6.14.3.3 Place the g
44、lass plate (see 6.14.1.4) centrally on top of the composite test specimen. Press lightly to remove air bubbles. 6.14.3.4 Place the assembly in a forced-draught oven (see 6.14.1.5) maintained at a temperature of 37 C 1 C for 4 h. 6.14.3.5 Remove the assembly from the forced-draught oven and remove th
45、e glass plate. 6.14.3.6 Separate the two cotton adjacent fabrics from the test specimen and allow them to dry separately at a temperature not higher than 60 C. 6.14.4 Evaluation 6.14.4.1 By means of the grey scales for assessing change in colour and staining (see 6.14.1.6) compare, under suitable il
46、lumination (as in SANS 105-A01), the change in colour of the test specimen and the staining of the cotton adjacent fabrics that have occurred. 6.14.4.2 Record, separately, the numerical ratings. Check for compliance with table 1. SANS 446:2010 Edition 4.1 10 6.15 X-ray opacity 6.15.1 Apparatus 6.15.
47、1.1 Non-screen X-ray film. 6.15.1.2 Lead sheeting, of thickness at least 2 mm, or lead-rubber sheeting of at least the same lead equivalent. 6.15.1.3 Aluminium sheet, of nominal thickness 30 mm, made of 99 % pure aluminium. 6.15.1.4 X-ray machine, capable of projecting radiation onto a non-screen X-
48、ray film. 6.15.2 Procedure 6.15.2.1 Place an X-ray-detectable swab or, in the case of X-ray-detectable absorbent gauze fabric, a test specimen of suitable size containing the X-ray-detectable component, on the centre of a non-screen X-ray film (see 6.15.1.1) positioned on a piece of the lead sheetin
49、g or lead-rubber sheeting (see 6.15.1.2). 6.15.2.2 Prevent scattered radiation from affecting the film by masking, with the sheeting, any parts of the film not covered by the test specimen. 6.15.2.3 Superimpose the aluminium sheet (see 6.15.1.3) on the assembly and irradiate (see 6.15.1.4) the test specimen and the aluminium simultaneously with X-rays at 70 kVp, using an exposure sufficient to give a logarithmic photographic density of about 1,0 through a 10 mm thickness of aluminium. 6.15.3 Evaluation Examine the
