1、BRITISH STANDARD BS ISO 11948-1:1996 Implementation of ISO 11948-1:1996 Urine-absorbing aids Part 1: Whole-product testing ICS 11.120.20; 11.180BSISO11948-1:1996 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the author
2、ity of the Standards Board and comes into effect on 15 May 1997 BSI 10-1998 The following BSI references relate to the work on this standard: Committee reference CH/47 Draft for comment 94/508292 DC ISBN 0 580 26682 6 Committees responsible for this British Standard The preparation of this British S
3、tandard was entrusted to Technical Committee CH/47, Aids for Ostomy and Incontinence, upon which the following bodies were represented: Association of Continence Advisors British Association of Urological Surgeons British Colostomy Association British Surgical Trades Association Chartered Society of
4、 Physiotherapy Department of Health Guild of Hospital Pharmacists Ileostomy Association of Great Britain and Ireland Infection Control Nurses Association Medical Research Council Medical Sterile Products Association National Association of Health Care Supplies Managers Royal College of Nursing Royal
5、 College of Surgeons of England Amendments issued since publication Amd. No. Date CommentsBSISO11948-1:1996 BSI 10-1998 i Contents Page Committees responsible Inside front cover National foreword ii Foreword iii Text of ISO 11948-1 1BSISO11948-1:1996 ii BSI 10-1998 National foreword This British Sta
6、ndard reproduces verbatim ISO 11948-1:1996 and implements it as the UK national standard. This British Standard is published under the direction of the Health and Environment Sector Board whose Technical Committee CH/47 has the responsibility to: aid enquirers to understand the text; present to the
7、responsible international committee any enquiries on interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. NOTEInternational and European Standards, as well as overseas standards, are available
8、from Customer Services, BSI, 389 Chiswick High Road, London W4 4AL. 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 immuni
9、ty from legal obligations. Summary of 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 6 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indi
10、cated in the amendment table on theinside front cover.BSISO11948-1:1996 ii BSI 10-1998 Contents Page Introduction 1 1 Scope 1 2 Normative references 1 3 Definitions 1 4 Principle 1 5 Preconditioning of test samples 1 6 Test conditions 1 7 Reagent 1 8 Apparatus 2 9 Procedure 2 10 Test report 5 Annex
11、A Bibliography 6 Figure 1 Test equipment 3 Figure 2 Drainage screen detail 4 Descriptors: Disabled persons, hygiene conditions, medical equipment, urine collection bags, urine absorbing aids, tests, determination, capacity, capacity measurement.BSISO11948-1:1996 BSI 10-1998 iii Foreword ISO (the Int
12、ernational 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 for which a technical committee ha
13、s 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 all matters of electrotechnical
14、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 ISO 11948-1 was prepared by Techn
15、ical 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; Part 2: Determination of short-time
16、liquid release (leakage) under conditions of light incontinence and low pressure. Annex A of ISO 11948 is for information only.iv blankBSISO11948-1:1996 BSI 10-1998 1 Introduction The method described in this part of ISO 11948 was selected from those used in the ISO Pad Leakage Project, in which a v
17、ariety of disposable urine-absorbing aids were tested in various ways in the laboratory and by a user population of about 100 heavily incontinent persons, the majority of whom were non-ambulatory adult females residing in hospitals or nursing homes in eight different countries. The applicability of
18、the method to other groups (e.g. babies or ambulatory adults) or to other classes of product (e.g. reusable or non-body worn) is unknown. See references 1 and 2 in annex A. The method measures the maximum absorption capacity of the absorbing material in the entire urine-absorbing aid. The method is
19、useful for comparing the performance of products whose absorbing cores are uniform in composition and absorbing properties, but it overestimates the amount of urine these products hold in actual use. The method has not been validated for predicting performance of urine-absorbing aids whose absorbent
20、 cores are designed to be non-uniform in composition and absorbing properties. Urine-absorbing aid user performance is affected by many other factors in addition to absorption capacity, such as: the pressure on the product; the posture of the user (e.g. sitting, standing, moving, lying down); the fl
21、owrate at which the user loses urine; and how well the product is put on. From user trials, urine-absorbing aid performance is also known 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
22、 to keep the product close to the body. This method does not differentiate these product features. 1 Scope This part of ISO 11948 specifies a method for determining the absorption capacity of the absorbent core of body-worn urine-absorbing aids. NOTEOther methods for measuring absorption capacity ex
23、amine aspects which are outside the scope of this part of ISO11948. 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, the editions indicated were valid. All standards a
24、re 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 editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 3696:1987,
25、Water for analytical laboratory use Specification and test methods. ISO 6353-2:1983, Reagents for chemical analysis Part 2: Specifications First series. 3 Definitions For the purposes of this part of ISO 11948, the following definition applies: 3.1 urine-absorbing aid product containing material for
26、 the purpose of absorbing urine 4 Principle The urine-absorbing aid is weighed dry, soaked in test liquid, drained, and weighed wet. Subtraction of the dry mass from the wet mass gives the absorption capacity. 5 Preconditioning of test samples Urine-absorbing aids shall be removed from their packing
27、, unfolded, and conditioned in an atmosphere of 23 C 2 C and 50 % 5 % relative humidity for 24 h to 36 h prior to testing. 6 Test conditions Urine-absorbing aids shall be tested at 23 C 2 C and 50 % 5 % relative humidity. 7 Reagent 7.1 Test liquid, c(NaCl) = 9,0 g/l, prepared at23C 2 C, comprising g
28、rade 3 distilled water as specified in ISO 3696, containing 9,0 g/l sodium chloride as specified in ISO 6353-2.BSISO11948-1:1996 2 BSI 10-1998 8 Apparatus 8.1 Reservoir, of dimensions not less than the length and width of the urine-absorbing aid to be tested, capable of containing test liquid to a d
29、epth of100mm. NOTEInternal dimensions of 900 mm 600 mm 150 mm are recommended. 8.2 Drainage screen (see Figure 1 and Figure 2), of length and width 20 mm less than the internal dimensions of the reservoir. The drainage screen is made of rods of 3 mm 0,25 mm diameter welded together to form a square
30、grid with 25 mm 1 mm between rod centres. The rods running parallel to the length of the drainage screen are underneath, and those parallel to its width are on top. The drainage screen (or the reservoir) is fitted with means for resting the drainage screen directly above the reservoir. NOTEThe rods
31、should be made from nonabsorbent, corrosion-resistant material. During pretests of the method, only rods made of stainless steel were used. Other material may affect the test results. 8.3 Drainage tray, of the same length and width as the drainage screen and of minimum internal depth25 mm, provided
32、with a means for sliding the drainage tray into and out of position between the reservoir and the drainage screen. 8.4 Balance, capable of measuring the dry mass of the urine-absorbing aid under test to the nearest0,1g. 8.5 Balance, capable of measuring the mass of the tared drainage tray and the we
33、t urine-absorbing aid under test to the nearest 1 g. 9 Procedure 9.1 Fill the reservoir to a depth of at least 100 mm with the test liquid. 9.2 Using the balance (8.4), measure the dry mass of the urine-absorbing aid to the nearest 0,1 g. 9.3 If the urine-absorbing aid has elastication, cut the elas
34、tics so that it will lay flat, ensuring that a route for absorbing material to escape is not created. 9.4 Lay the urine-absorbing aid flat on the drainage screen. If the urine-absorbing aid is fitted with a barrier to liquid on one side, ensure that this side faces upwards. If the barrier to liquid
35、extends beyond the edge of the drainage screen, ensure that it is not tucked underneath the urine-absorbing aid such as to impede absorption during the test. 9.5 Lower the drainage screen and urine-absorbing aid to the bottom of the reservoir. 9.6 Leave the urine-absorbing aid to soak for30min 30 s
36、if it contains any superabsorbent material, or 5 min 10 s if it does not. 9.7 Massage the urine-absorbing aid gently while it is soaking to remove any pockets of trapped air.BSISO11948-1:1996 BSI 10-1998 3 Figure 1 Test equipmentBSISO11948-1:1996 4 BSI 10-1998 Figure 2 Drainage screen detailBSISO119
37、48-1:1996 BSI 10-1998 5 9.8 Raise the drainage screen and urine-absorbing aid clear of the reservoir and allow excess liquid to drain back under gravity into the reservoir from the urine-absorbing aid for 5 min 10 s. Ensure that no puddles of test liquid gather on the top of the barrier to liquid, i
38、f the urine-absorbing aid is fitted with one. 9.9 Tare the balance (8.5) to the dry mass of the drainage tray. 9.10 Slide the drainage tray into position between the reservoir and the drainage screen. 9.11 Roll up the urine-absorbing aid, allowing any fluid that is displaced by the rolling procedure
39、 to fall through into the drainage tray. 9.12 Weigh the wet urine-absorbing aid, the drainage tray and any liquid it contains on the tared balance, to the nearest 1 g. 0.1 9.13 Subtract the dry mass of the urine-absorbing aid from the mass measured in 9.12 to give the absorption capacity, to the nea
40、rest 1 g. 9.14 Repeat steps 9.1 to 0.19.13 until at least five samples of the urine-absorbing aid have been tested. 10 Test report The test report shall include the following information: a) a reference to this part of ISO 11948; b) identity of the urine-absorbing aid tested; c) the material from wh
41、ich the drainage-screen rods are made; d) the number of individual tests; e) for each individual test: the dry mass, reported to the nearest 0,1 g, the absorption capacity, reported to the nearest 1 g; f) for all of the repeats: the arithmetic mean of the dry masses, reported to the nearest 0,1 g, t
42、he standard deviation of the dry masses, reported to the nearest 0,01 g, the arithmetic mean absorption capacity, reported to the nearest 1 g, the standard deviation of the absorption capacities, reported to the nearest 0,1 g; g) date and place of testing; h) any other information, as agreed between
43、 product supplier and customer; i) any deviation from the method specified in this part of ISO 11948 which may influence the test results.BSISO11948-1:1996 6 BSI 10-1998 Annex A (informative) Bibliography 1 A.M. COTTENDEN, The ISO Pad Leakage Project: Findings to date, INDA J. Nonwovens Res., 2 (2),
44、1990, pp. 23-28. 2 A.M. COTTENDEN and D.J. LEDGER, The ISO Pad Leakage Project: An update, INDA J. Nonwovens Res., 3 (2), 1991, pp. 52-60. 3 ISO 9949-1:1993, Urine absorbing aids Vocabulary Part 1: Conditions of urinary incontinence. 4 ISO 9949-2:1993, Urine absorbing aids Vocabulary Part 2: Product
45、s. 5 ISO 9949-3:1993, Urine absorbing aids Vocabulary Part 3: Identification of product types.blankBSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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