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1、BRITISH STANDARD BS ISO 11948-2:1998 Urine-absorbing aids Part 2: Determination of short-time liquid release (leakage) under conditions of light incontinence and low pressure ICS 11.120.99; 11.180 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c)
2、BSI BS ISO 11948-2:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 June 1998 BSI 04-1999 ISBN 0 580 29773 X National foreword This British Standard re
3、produces verbatim ISO 11948-2:1998 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/47, Aids for ostomy and incontinence, which has the responsibility to: aid enquirers to understand the text; present to the responsible in
4、ternational/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to
5、its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI
6、Standards Electronic Catalogue. 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 o
7、f pages This document comprises a front cover, an inside front cover, pages i and ii, the ISO title page, pages ii to iv, pages 1 to 4 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the
8、inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11948-2:1998 BSI 04-1999i Contents Page National forewordInside front cover Forewordiii Text of ISO 11948-21
9、Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 200
10、6, Uncontrolled Copy, (c) BSI BS ISO 11948-2:1998 ii BSI 04-1999 Contents Page Forewordiii Introduction1 1Scope1 2Normative references1 3Definitions1 4Principle2 5Conditioning2 6Test conditions3 7Reagent3 8Apparatus3 9Procedure3 10Test report3 Figure 1 Equipment for use in the test2 Table 1 Filter p
11、aper properties3 Descriptors: Disabled persons, hygiene conditions, medical equipment, urine collection bags, urine absorbing aids, tests, performance tests, leak tests. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11948-2:1998 BSI
12、 04-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject f
13、or which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on
14、 all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard
15、ISO 11948-2 was prepared by Technical Committee ISO/TC 173, Technical systems and aids for disabled or handicapped persons, Subcommittee SC 3, Aids for ostomy and incontinence. ISO 11948 consists of the following parts, under the general title Urine-absorbing aids: Part 1: Whole-product testing; Par
16、t 2: Determination of short-time liquid release (leakage) under conditions of light incontinence and low pressure. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+0
17、0:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11948-2:1998 BSI 04-19991 Introduction The test method described in this part of ISO 11948 was selected from those used in the ISO Pad Leakage Project 2, in which a variety of disposable bodyworn urine-absorbing aids were tested in various ways in the lab
18、oratory and by a user population of about 100 lightly incontinent women from eight different countries, the majority of whom were ambulatory and residing in their own homes. The method measures the amount of liquid release (leakage) of the absorbing material in the crotch area of a urine-absorbing a
19、id under defined conditions of time and pressure. Other conditions of time and pressure could be used, but would give different test results and could not be stated to comply with this standardized procedure. In addition to liquid release under the conditions of time and pressure required in this te
20、st method, urine-absorbing in-use performance is affected by many other factors, such as: different pressures placed on the product than those specified here; the posture of the user (e.g. sitting, standing, moving, lying down); the flowrate at which the user loses urine; the amount of urine lost; a
21、nd how well the product is put on. Urine-absorbing aid user performance is also known from user trials to be affected by composition and design features, such as shaping; profiling; composition of the absorbent core; elastication; and the kind of fixation system used to keep the product close to the
22、 body. The present method does not differentiate these product features. Further, the method may not accurately reflect in-use performance of absorbing aids whose absorbent cores are designed to be non-uniform in composition and in absorbing properties in the test area. International Standard ISO 99
23、49, parts 1 to 3, Urine-absorbing aids Vocabulary, serve as general guidance for the work within this field. 1 Scope This part of ISO 11948 specifies a method for determining the amount of liquid that is released (leakage) from a wet bodyworn urine-absorbing aid when compressed at 1,5 kPa. The metho
24、d is applicable for testing of products that are intended to be used only for very light urine incontinence reasons. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 11948. At the time of publication, t
25、he editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 11948 are encouraged to investigate the possibility of applying the most recent edition of the standards indicated below. Members of IEC and ISO maintain registers of currentl
26、y valid International Standards. ISO 384:1978, Laboratory glassware Principles of design and construction of volumetric glassware. ISO 534:1988, Paper and board Determination of thickness and apparent bulk density or apparent sheet density. ISO 536:1995, Paper and board Determination of grammage. IS
27、O 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 5637:1989, Paper and board Determination of water absorption after immersion in water. ISO 6353-2:1983, Reagents for chemical analysis Part 2: Specifications First series. ISO 8787:1986, Paper and board Determinatio
28、n of capillary rise Klemm method. 3 Definitions For the purposes of this part of ISO 11948, the following definitions apply. 3.1 urine-absorbing aid product containing material for the purpose of absorbing urine 3.2 crotch area area (of a urine-absorbing aid) of nonspecific dimensions located upon t
29、he absorbent core of the urine-absorbing aid such that its central point is coincident with the centrepoint of the core itself NOTEThe shapes of absorbent cores make a more specific definition difficult, but the centrepoint of the core is best approximated as the intersection of the imaginary lines
30、that would bisect the core in each of its principle directions, length and width. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11948-2:1998 2 BSI 04-1999 4 Principle 25 ml of test liquid is applied to the crotch area of a whole pad
31、 and left to soak for 1 min. A weighed piece of filter paper is then applied to the wetted crotch region and compressed under a pressure of 1,5 kPa for 1 min. After this time, the pressure is removed, the filter paper reweighed and the gain in mass of the filter paper is recorded as the “liquid rele
32、ase (leakage)”. 5 Conditioning 5.1 Test samples Urine-absorbing aids shall be removed from packing and unfolded and shall be conditioned in an atmosphere of 23 C 2 C and (50 % 5 %) relative humidity (RH) for 24 h to 36 h prior to testing. 5.2 Filter paper Filter paper (8.2) shall be conditioned in a
33、n atmosphere of 23 C 2 C and 50 % RH 5 % RH for 24 h prior to use. Key 1 Pipette (of 25 ml capacity) (see 8.3) 2 0,9 % saline solution (see 7.1) 3 Pad core 4 Crotch area (see 3.2) 5 Weight (see 8.4) 6 Filter paper beneath weight (see 8.2) 1) See 9.4 NOTEThe pad core shown is only an example. Many ot
34、her shapes and sizes will be encountered. Figure 1 Equipment for use in the test Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11948-2:1998 BSI 04-19993 Table 1 Filter paper properties 6 Test conditions Urine-absorbing aids shall be
35、 tested at 23 C 2 C and 50 % RH 5 % RH. 7 Reagent 7.1 Test liquid, prepared at 23 C 2 C comprising Grade 3 distilled water, as specified in ISO 3696, and containing 9,0 g/l sodium chloride, as specified in ISO 6353-2. 8 Apparatus 8.1 Top-loading balance, capable of measuring accurately to 0,001 g. 8
36、.2 Filter paper, complying with the specifications in Table 1. NOTECircular Whatman No. 1 filter paper of diameter 110 mm is an example of a suitable product available commercially. This information is given for the convenience of users of this part of ISO 11948 and does not constitute an endorsemen
37、t by ISO of this product. 8.3 Pipette, calibrated to deliver 25 ml of water in 20 s 5 s at 20 C and complying with the general requirements for class A or B volumetric glassware as specified in ISO 384. The general style of the pipette to be used is shown in Figure 1. 8.4 Weight, 115 mm long, 60 mm
38、wide, having a mass of 1,050 kg 0,002 kg. NOTE 1This provides a pressure of 1,5 kPa when laying on a 115 mm 60 mm area. If necessary with respect to the shape of the product, the dimensions of the weight may be adjusted, as long as the stated pressure of 1,5 kPa is obtained. NOTE 2The weight may be
39、made from a rigid, noncorroding material of the users choice, such as brass, stainless steel or rigid plastic. 8.5 Stopwatch, or similar timing device. 9 Procedure 9.1 Place a urine-absorbing aid absorbent face up, flat, on the work surface. 9.2 If the urine-absorbing aid has elastication, cut the e
40、lastics so that it will lay flat on the work surface, ensuring that a route for absorbing material to escape is not created. 9.3 Using the balance (8.1), record the dry mass of the filter paper to the nearest 0,001 g. 9.4 Fill the pipette (8.3) and holding it with its tip 20 mm 5 mm above the surfac
41、e at the crotch area allow 25 ml of liquid to flow freely onto the test specimen. 9.5 As soon as the liquid has been absorbed, or after 1 min has elapsed from the application of the liquid, whichever is first to occur, place the preweighed filter paper on the surface at the crotch area, taking care
42、not to apply any pressure. 9.6 Apply the weight (8.4) centrally to the urine-absorbing aid and allow to stand for 1 min 5 s (see Figure 1). 9.7 Remove the weight and, using the balance (8.1), immediately reweigh the filter paper accurately to 0,001 g. 9.8 Calculate and record the “liquid released (l
43、eakage)” as follows: Subtract the dry mass of filter paper from the wet mass of filter paper to give the mass of liquid released (leakage) and record to the nearest 0,01 g. 9.9 Repeat steps 9.1 to 9.8 until at least five samples of the urine-absorbing aid have been tested. 9.10 Calculate and record
44、the arithmetic mean of the mass of liquid released (leakage) for each sample, to the nearest 0,01 g. 10 Test report The test report shall include at least the following information: a) a reference to this part of ISO 11948; b) identity of the urine-absorbing aid tested; c) the number of individual t
45、ests; d) for each individual test, report the amount “liquid released (leakage)” to the nearest 0,01 g; e) for all of the tests done on each urine aid tested, report the arithmetic mean “liquid released (leakage)” results to the nearest 0,01 g. f) date and place of testing; PropertyUnitsTest method
46、reference Specification TargetLimits Grammageg/m2ISO 5388778 to 96 Thicknessmicrometres (4m)ISO 534180154 to 208 Klemm absorption rate s/7,5 cmISO 8787780max. 900 Absorption capacity mg/cm3ISO 563716min. 14 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled
47、Copy, (c) BSI BS ISO 11948-2:1998 4 BSI 04-1999 g) any other information as agreed between product supplier and customer; h) any deviation from the method specified in this part of ISO 11948 which may have influence on the test results. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24
48、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:24 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11948-2:1998 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible
49、 for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would info
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