1、BRITISH STANDARD BS EN ISO 16021:2001 Urine-absorbing aids Basic principles for evaluation of single-use adult-incontinence- absorbing aids from the perspective of users and caregivers The European Standard EN ISO 16021:2000 has the status of a British Standard ICS 11.120.99; 11.180 NO COPYING WITHO
2、UT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN ISO 16021:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 2001 BSI 03-2001 I
3、SBN 0 580 37092 5 National foreword This British Standard is the official English language version of EN ISO 16021:2000. It is identical with ISO 16021:2000. The UK participation in its preparation was entrusted to Technical Committee CH/47, Aids for ostomy and incontinence, which has the responsibi
4、lity to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding
5、 European publications. The British Standards which implement these international or European publications 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.
6、 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. aid enquirers to understand the text; pr
7、esent to the responsible international/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. Summary of pages This document comprises a front cover, a
8、n inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 11, and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Co
9、mmentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO16021 November2000 ICS11.180 Englishversion UrineabsorbingaidsBasicprinciplesforevaluationofsingle useadultincontinenceabsorbingaidsfromtheperspectiveof usersandcaregivers(ISO16021:2000) AidespourabsorptiondurinePrincipesdebasepour lvaluation
10、desaidespourincontinentsadultesparles utilisateursetlepersonnelsoignant(ISO16021:2000) UrinaufsaugendeHilfsmittelGrundprinzipienfrdie BewertungvonEinmalgebrauchsHilfsmittelnfr inkontinenteErwachseneausderSichtvonAnwendernund Pflegekrften(ISO16021:2000) ThisEuropeanStandardwasapprovedbyCENon1November
11、2000. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreort
12、oanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofA
13、ustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B105
14、0Brussels 2000CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO16021:2000EForeword ThetextoftheInternationalStandardISO16021:2000hasbeenpreparedbyTechnical CommitteeISO/TC173“Technicalsystemsandaidsfordisabledorhandicappedpersons“in collaborationw
15、ithTechnicalCommitteeCEN/TC293“Technicalaidsfordisabledpersons“, thesecretariatofwhichisheldbySIS. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublication ofanidenticaltextorbyendorsement,atthelatestbyMay2001,andconflictingnational standardsshallbewithdrawnatthelatestbyMay20
16、01. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,Switzerlan
17、dandtheUnited Kingdom. Endorsementnotice ThetextoftheInternationalStandardISO16021:2000wasapprovedbyCENasaEuropean Standardwithoutanymodification. ENISO16021:2000 Reference number ISO 16021:2000(E) INTERNATIONAL STANDARD ISO 16021 First edition 2000-11-01 Urine-absorbing aids Basic principles for ev
18、aluation of single-use adult-incontinence- absorbing aids from the perspective of users and caregivers Aides pour absorption durine Principes de base pour lvaluation des aides pour incontinents adultes par les utilisateurs et le personnel soignant ENISO16021:2000 ii ENISO16021:2000 ISO 12061:(0002)E
19、iii Contents Page Foreword.iv Introduction.v 1 Scope 1 2 Terms and definitions .1 3 Creating the evaluation protocol2 4 Data-gathering tools3 5 User trial procedure.5 6 Data collection .6 7 Evaluation report .7 Bibliography11 ENISO16021:2000 ISO 12061:(0002)E iv Foreword ISO (the International Organ
20、ization 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 has been establish
21、ed 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 standardization.
22、 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. 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
23、the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 16021 was prepared by Tech
24、nical Committee ISO/TC 173, Technical systems and aids for disabled or handicapped persons, Subcommittee SC 3, Aids for ostomy and incontinence. ENISO16021:2000 ISO 12061:(0002)Ev Introduction This International Standard provides basic principles for conducting user evaluation of single-use, body-wo
25、rn urine- absorbing aids by adult incontinent users, their caregivers, or both. It gives guidance in the understanding of product performance in actual use and hence can be used when making purchasing or reimbursement decisions, or both, from among a variety of products whose performance characteris
26、tics vary. The focus of this International Standard is on the basic principles, which should be considered for evaluation of a single product in actual use. Where several products are to be evaluated, the procedure suggested should be applied to each, although the exact evaluation protocol used migh
27、t vary, based on the unique characteristics of each product, the population of users being used for the evaluation, or both. The comparison of user evaluation data obtained in evaluating several products is statistically complex and highly dependent upon the information desired from the evaluation,
28、the differences between or among products, and the size of the user population used in the evaluation, to mention only three important factors. Direct comparison between products based on statistical parameters is not covered by this International Standard. It is essential that those wishing to make
29、 statistically robust comparisons between different products consult a medical statistician for advice on, for example, the number of evaluation subjects they should recruit and randomizing the order of evaluating different products. This International Standard draws on a French national standard Q3
30、4-019: Mt h o d ed e s s a ia up o r t e rp o u rl e s articles dhygine infantile, fminine et de lincontinence (articles usage unique) and the protocols for incontinence product evaluation developed by the Continence Products Evaluation Network at University College London, England. This Internation
31、al Standard is based upon an extensive body of data and experimentation on the ways in which evaluation of incontinence products by users may be done to gain useful information on product performance for a variety of purposes. Selected references are given in the Bibliography as an aid to the user o
32、f this International Standard in applying it to particular situations of interest. ISO 16021 should be read in conjunction with the following related International Standards for Urine-absorbing aids: ISO 9949-1, Urine absorbing aids Vocabulary Part 1: Conditions of urinary incontinence. ISO 9949-2,
33、Urine absorbing aids Vocabulary Part 2: Products. ISO 9949-3, Urine absorbing aids Vocabulary Part 3: Identification of product types. ISO 11948-1, Urine-absorbing aids Part 1: Whole-product testing. ISO 11948-2, Urine-absorbing aids Part 2: Determination of short-time liquid release (leakage) under
34、 conditions of light incontinence and low pressure. ISO 15621, Urine-absorbing aids General guidance on evaluation. ENISO16021:2000 ENISO16021:2000 INTENRATIONAL TSANDADR ISO 12061:(0002)E1 Urine-absorbing aids Basic principles for evaluation of single- use adult-incontinence-absorbing aids from the
35、 perspective of users and caregivers 1 Scope This International Standard provides guidelines for designing and conducting a user evaluation of single-use adult- incontinence-absorbing aids. It provides guidance on creating data collection tools. In particular, it provides a framework for eliciting a
36、nd recording the views of users and their carers on product performance. In addition, an optional approach for establishing the leakage performance and wear times of products and the mass of urine in them is described. This International Standard does not cover direct comparison between products bas
37、ed on statistical parameters. 2 Terms and definitions For the purposes of this International Standard, the following terms and definitions apply (in alphabetical order). 2.1 caregiver person who assists user(s) with applying and changing incontinence products NOTE Caregivers may be paid staff or fam
38、ily/friends. 2.2 ethics committee body whose role is to protect the interests of evaluation subjects particularly in institutions by inspecting proposed evaluation protocols NOTE Ethics committee permission is normally required before an evaluation can begin. 2.3 evaluation centre coordinator person
39、 in charge of the evaluation in a given centre 2.4 principal investigator person in overall charge of an evaluation 2.5 product body-worn absorbent product intended to aid incontinent persons NOTE Further information regarding products and product types is given in ISO 9949-2 and ISO 9949-3. 2.6 pro
40、duct line group of similar products provided by a manufacturer/supplier which have similar construction but which differ from one another in such details as size or absorbency level ENISO16021:2000 ISO 12061:(0002)E 2 2.7 user person who wears the product(s) subject to evaluation 3 Creating the eval
41、uation protocol 3.1 Questionnaires This evaluation employs a series of questionnaires designed to collect users/caregivers observations and opinions on aspects of the performance of an incontinence product, or several products, over an agreed period of time. Further questionnaires are used to ascert
42、ain the age and health of the user, the severity of their incontinence and other relevant background information. The information entered on the questionnaires is processed for each user and each product tested at the end of the evaluation period and is used to produce a report on the performance of
43、 each product in terms of the level of satisfaction of the users. This International Standard does not provide a standard protocol, since objectives for running evaluations, user populations, evaluation sites, products, and specific data of interest vary widely. Instead, it lists the primary issues,
44、 which should be considered in creating a protocol, along with guidelines on how to address them. A record of the decisions made on these issues should be included in the evaluation report (see 7). NOTE Some lists of issues to be considered in writing questionnaires and other documentation are provi
45、ded, but users of this International Standard are cautioned against using any of them exactly as found here without first verifying their usefulness for the intended study. 3.2 Selection of products The products (2.5) or product lines (2.6) to be evaluated should be selected. Consideration should be
46、 given to obtaining samples from multiple production batches in order to randomize the selection and reduce the impact of atypical results emanating from, say, a faulty batch. 3.3 Selection of users A group of users appropriate to the product to be evaluated should be selected in accordance with the
47、 manufacturers intended use, as described in their sales literature. The severity of users incontinence should be matched to the absorbency of the product(s) as declared by the manufacturer. NOTE 1 In order to make a good match between users and products it may be useful to establish the absorption
48、requirements of potential evaluators by weighing their used pads over a period of several days. Sample populations should be of distinct end-user groups. Users should be chosen from either institutions or home settings but not both since practices, requirements and priorities often differ. NOTE 2 Users in their own homes may manage their incontinence independently or rely on help from caregivers. It is advisable to sel
