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1、BRITISH STANDARD BS ISO 15621: 1999 Urine-absorbing aids General guidance on evaluation ICS 11.120.99; 11.180 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15621:1999 This British Standard, having been prepared under the direction o
2、f the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 June 1999 BSI 03-2000 ISBN 0 580 32496 6 National foreword This British Standard reproduces verbatim ISO 15621:1999 and implements it as the UK national standard. T
3、he 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 international/European committee any enquiries on the interpretation, or proposals fo
4、r 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 its secretary. Cross-references The British Standards which implement international
5、 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 Standards Electronic Catalogue. A British Standard does not purport to include all
6、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 of pages This document comprises a front cover, an inside front cover, pages i and i
7、i, 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 inside front cover. Amendments issued since publication Amd. No.DateComments Licens
8、ed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15621:1999 BSI 03-2000i Contents Page National forewordInside front cover Forewordiii Text of ISO 156211 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontr
9、olled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15621:1999 ii BSI 03-2000 Contents Page Forewordii
10、i Introduction1 1Scope1 2Terms and definitions1 3Evaluation of urine-absorbing aids1 3.1Approaches to the problem1 3.1.1Statement of problem1 3.1.2Testing in the laboratory1 3.1.3Testing in user trials1 3.2Important factors in making product choices2 3.2.1Severity, frequency and nature of the incont
11、inence2 3.2.2Independence/lifestyle2 3.2.3Ease of putting on/taking off2 3.2.4Staying in place2 3.2.5Normality and discretion2 3.2.6Freedom from leakage2 3.2.7Comfort3 3.2.8Skin health3 3.2.9Product safety legislation3 3.2.10 The environment3 3.2.11 Cost3 3.3Choice of test3 Bibliography4 Licensed Co
12、py: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15621:1999 BSI 03-2000iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Interna
13、tional Standards is normally carried out through ISO technical committees. Each member body interested in a subject for 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
14、ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standar
15、ds 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 15621 was prepared by Technical Committee ISO/TC 173, Technical systems a
16、nd aids for disabled or handicapped persons, Subcommittee SC 3, Aids for ostomy and incontinence. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncont
17、rolled Copy, (c) BSI BS ISO 15621:1999 BSI 03-20001 Introduction This International Standard constitutes a general introduction to the methodology of testing urine-absorbing aids of the type used by persons with incontinence, and should be read before undertaking the more detailed test procedures de
18、scribed in other International Standards. It covers the general area of methodology and is intended to fulfil the following objectives: a) to provide a brief background of the essential features of methods of testing urine-absorbing aids for the user of specific tests; b) to provide details of gener
19、al requirements, procedures and interpretation of results common to all or most tests; c) to provide sufficient guidance on requirements, procedures and interpretation of results for the different specific tests to allow choice of the most appropriate procedure(s) for solution of a particular proble
20、m. ISO 15621 covers the test methods described in ISO 11948-1 and ISO 11948-2. The terminology presented in ISO 9949, all parts, serves as general guidance for the work within this field. 1 Scope This International Standard gives general guidance on the methodology of evaluating urine-absorbing aids
21、, and provides a context for the procedures described in other International Standards or published testing procedures. 2 Terms and definitions For the purposes of this International Standard, the following term and definition apply. 2.1 urine-absorbing aid product containing material for the purpos
22、e of absorbing urine 3 Evaluation of urine-absorbing aids 3.1 Approaches to the problem 3.1.1 Statement of problem Choosing the best urine-absorbing aid, whether it is a single purchase for an individual or a bulk buy for a whole hospital, is a complex business, not least because different users and
23、 buyers have different needs and prioritize those needs in different ways. 3.1.2 Testing in the laboratory Laboratory tests can provide a practical approach to product evaluation, monitoring product consistency and conformity against a standard, and comparative studies on the range of available prod
24、ucts. Laboratory tests can certainly be used to test a large variety of products in a short time, and many laboratory tests give reproducible results. However, care should be taken in extrapolating the results of laboratory tests to performance in real use. Furthermore, validated laboratory tests fo
25、r predicting such important human aspects of urine-absorbing product performance as comfort or ease of application have not yet been devised, and doing so is likely to prove very difficult. 3.1.3 Testing in user trials Another way to make informed choices is to run user trials. But they are time-con
26、suming and expensive, and it would be impractical to try all of the many different products which are available. Unless a user trial has been properly designed and executed, it can be very misleading. Besides, it is notoriously difficult to extrapolate results gained with one group of people to othe
27、r, apparently similar, groups. In addition, trial results soon go out of date. Products are frequently modified or replaced and so there is a continual stream of new products to be evaluated. The answer to making the best choice for a particular need from among the many products available certainly
28、lies in a combined approach of both laboratory and user trials (clinical testing). Effectiveness in the hands of the particular user(s) for whom the product is being chosen will always be the ultimate mark of a successful selection, but laboratory tests and the cumulative experience of other users o
29、f the product, recorded in published trials, have a lot to offer. The results of a number of urine-absorbing aid trials have been published over the years (see Bibliography). Most of them have involved products that are no longer available, but some invaluable guidelines can be gleaned from them. Th
30、e first and most important observation is this: No trial has ever identified a product which has proved suitable for every user. Individual preferences, priorities and circumstances vary and need to be taken into account, and a wide assortment from which to choose is a prerequisite for finding optim
31、al individual solutions. However, using the published trials as a starting point, it is possible to compile a list of those factors which, in general, should be considered in making choices. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS
32、 ISO 15621:1999 2 BSI 03-2000 3.2 Important factors in making product choices NOTEThe factors are not separate; rather, they are interrelated. 3.2.1 Severity, frequency and nature of the incontinence How much urine does the person leak, how often, and with how much warning? Some people leak only sma
33、ll quantities of urine on infrequent occasions. A small urine-absorbing aid will be perfectly adequate. Others may lose a substantial quantity in one go but have sufficient warning to get to a toilet in time if there is one nearby. They may find it unnecessary to wear a urine-absorbing aid at all in
34、 their own home (since they have ready access to their toilet) but will need a highly absorbent urine-absorbing aid if they venture outside. The urine-absorbing aid which will meet the needs of these people must rapidly absorb urine, and distribute it within the absorbent urine-absorbing aid materia
35、ls while retaining the urine under a variety of circumstances. 3.2.2 Independence/lifestyle Manual dexterity, mobility, mental acuity, availability of assistance, desired activities, and other variables related to the product user all impact the choice of the product by the user. In addition to the
36、ergonomics of putting on and taking off the product, its disposability may be an issue of high priority. In general, those able to change their own urine-absorbing aid whenever they choose will be able to manage with a smaller urine-absorbing aid than those who are reliant on a caregiver. In additio
37、n, those whose lifestyles take them away a lot, e.g. on business or social matters, will need to think carefully about how easy it will be to carry a supply of urine-absorbing aids, dispose of them, and deal with any laundry. These factors will influence their choice of product. Some people with inc
38、ontinence will prefer a less effective product that they can change themselves to a more effective one which makes them dependent upon help. 3.2.3 Ease of putting on/taking off The ease with which a urine-absorbing aid can be put on or taken off is especially important for caregivers and for use by
39、people with incontinence with reduced mobility or manual dexterity. Some products are difficult to take off without coming into contact with urine-soaked absorbent material an unpleasant experience for caregivers in particular. 3.2.4 Staying in place The most absorbent product is of limited use if i
40、t has slipped out of place when incontinence occurs. Briefs and underpads generally stay in place well. Inserts are dependent on close-fitting underwear or adhesive strips. Shaped products may stay in place better than rectangular ones. Fastenability using adhesive tapes, elastication, barrier cuffs
41、, and design form (taped brief, tapeless brief, etc.) may be important considerations in product selection. 3.2.5 Normality and discretion People with incontinence wish to have lives that are as normal as possible, e.g. they wish to be unrestricted in what they can wear. Some will want to wear tight
42、 clothing which would reveal all but the smallest of urine-absorbing aids. They may prefer the discretion of a small urine-absorbing aid even though it is more likely to leak than a bulkier urine-absorbing aid which would be more visible beneath clothing. Some will be sensitive to the possibility of
43、 neighbours seeing any special incontinence underwear they may have on the back yard washing line. Another aspect of discretion is noise: does the product rustle when the user moves? Yet another aspect of discretion is odour. The fear of smelling is usually greater than the real risk. Most smell der
44、ives from stale urine which has found its way into furnishings and clothing. Accordingly, the best way of minimizing smell is to use a urine-absorbing aid which leaks as little as possible. Some urine-absorbing aids contain deodorizing material, but there is little published evidence that they are a
45、ny more effective. 3.2.6 Freedom from leakage It is a fundamental requirement of a urine-absorbing aid that it should leak as little as possible and, ideally, not at all. But there are compromises to be made. Urine-absorbing aid weighing data indicate (see 8, Bibliography) that even those who someti
46、mes lose a large quantity of urine into a urine-absorbing aid (350 ml, say) usually leak far less (typically less than 100 ml). Light wetters often exhibit similar ratios between the quantities of urine they lose in their worst and in their usual accidents. Accordingly, the urine-absorbing aid they
47、will need to contain their worst-ever accident may be much more bulky and expensive than that needed most of the time. Different people will be willing to tolerate different severities and frequencies of leakage from their urine-absorbing aids in exchange for being able to use cheaper, smaller and/o
48、r more discrete urine-absorbing aids. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15621:1999 BSI 03-20003 Properties and features known to have an impact on freedom from leakage include, for example, absorption capacity, absorptio
49、n speed, retention capacity and wetback properties, fit, shaping, elastication and barrier cuffs. Wetness indicators may be useful to caregivers in judging when best to change a urine-absorbing aid, to minimize the risk of leakage and sore skin. 3.2.7 Comfort Comfort is a property difficult to define, but all incontinent people agree that some urine-absorbing aids are more comfortable than others. In general, urine-absorbing aids which keep the skin dry are more comfortable than those that do not; urine-absorbing aids which are compliant enough to adapt to the shape o
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