EN ISO 15621-2017 en Absorbent incontinence aids for urine and or faeces - General guidelines on evaluation.pdf

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1、Absorbent incontinence aids for urine and/or faeces General guidelines on evaluationBS EN ISO 15621:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 15621:2017. It is identical to ISO 15621:

2、2017. It supersedes BS ISO 15621:2011, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/173, Assistive products for persons with disability.A list of organizations represented on this committee can be obtained on request to its secretary.This publica

3、tion does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 86877 1ICS 11.180.20Compliance with a British Standard cannot confer immunity f

4、rom legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 15621:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15

5、621July 2017ICS 11.180.20EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 15621:2017: EAll rights of exploitation in any form and by any means reserved worldwide

6、 for CEN national MembersAbsorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)Aides lincontinence pour labsorption durine et/ou de matires fcales - Directives gnrales dvaluation (ISO 15621:2017)Hilfen zur Urinabsorption - Allgemeine Richtlinien fr di

7、e Evaluierung (ISO 15621:2017)This European Standard was approved by CEN on 28 May 2017.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date list

8、s and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under t

9、he responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugos

10、lav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 15621:2017 (E)European f

11、orewordThis document (EN ISO 15621:2017) has been prepared by Technical Committee ISO/TC 173 “Assistive products for persons with disability” in collaboration with Technical Committee CEN/TC 293 “Assistive products for persons with disability” the secretariat of which is held by SIS.This European St

12、andard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2018, and conflicting national standards shall be withdrawn at the latest by January 2018.Attention is drawn to the possibility that some of the elements of

13、 this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austri

14、a, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain,

15、 Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 15621:2017 has been approved by CEN as EN ISO 15621:2017 without any modification.iiBS EN ISO 15621:2017ISO 15621:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Eval

16、uation requirements . 44.1 General . 44.2 User-related factors 44.2.1 General 44.2.2 Quality of life . 44.2.3 Independence or assistance . 44.2.4 Nature of incontinence . 44.2.5 End user characteristics 54.2.6 Activities 54.2.7 Individual needs . 54.2.8 Handling products 64.3 Product-related factors

17、 64.3.1 General 64.3.2 Freedom from leakage 64.3.3 Freedom from odour leakage 64.3.4 Skin health . 74.3.5 Comfort and fit . 74.3.6 Discretion . 74.4 Usage-related factors . 84.4.1 Ergonomics . 84.4.2 Needs of carer . 84.4.3 Information supplied . 84.4.4 Laundry facilities . 84.4.5 Disposal facilitie

18、s . 84.4.6 Sustainability and environment . 84.4.7 Product safety . 94.4.8 Cost 94.5 Evaluation methods 94.5.1 General 94.5.2 Testing in the laboratory . 94.5.3 Testing in user trials 104.5.4 Combined approach .104.5.5 Interpretation of test results 104.5.6 Sample size 11Bibliography .12 ISO 2017 Al

19、l rights reserved iiiContents PageBS EN ISO 15621:2017ISO 15621:2017(E)ForewordISO (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 techni

20、cal 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 ISO, also take part in the work. ISO collaborates closely w

21、ith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed

22、 for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rig

23、hts. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in thi

24、s document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Tr

25、ade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by ISO/TC 173, Assistive products for persons with disability, Subcommittee SC 3, Aids for ostomy and incontinence.This third edition cancels and

26、 replaces the second edition (ISO 15621:2011), which has been technically revised.iv ISO 2017 All rights reservedBS EN ISO 15621:2017ISO 15621:2017(E)IntroductionIncontinence is a set of diseases that affects between 4 % and 8 % of the population or the lives of approximately 400 million people worl

27、dwide. Absorbent aids can help people affected by urinary and/or faecal incontinence to live an independent and dignified life. There are many absorbent incontinence aids on the market that can help persons to stay dry and comfortable. They can be purchased at pharmacies or supermarkets by consumers

28、 or via public procurement from producers or wholesalers, but selecting the right product can be difficult.There are many factors to consider when choosing absorbent incontinence aids, for example: the particular needs of the end user (e.g. the nature and severity of their incontinence); the needs o

29、f an assisting carer (e.g. ergonomics in the design of the product); the design of the aids (e.g. inserts, all-in-ones, pull-ons), their characteristics (e.g. absorption capacity and ease of putting on) and cost; environmental factors.Currently, there is a limited amount of published data on these f

30、actors. ISO 15621 gives guidance for evaluating absorbent incontinence aids so that informed choices can be made. It describes the needs of the incontinent population, lists the most important factors for end users and caregivers and gives an overview of testing methodologies/interpretation of test

31、results.There are a number of stakeholders who could benefit from using this document, e.g. purchasers within healthcare systems, nursing home managers, prescribers, caregivers, manufacturers, suppliers, sick funds, insurance companies and end users. These stakeholders often have different prioritie

32、s and different needs. However, it is important to remember that the most important stakeholder is always the end user. End users have different needs depending on, for example, their gender, age, the nature and severity of incontinence, mobility, dexterity, mental health, lifestyle, and personal pr

33、iorities. These factors should be taken into account when the most appropriate products are being chosen by/for them. Practical, in-use suitability is best determined by testing products with the individual end user.Other standards that might be useful for evaluating absorbent incontinence aids and

34、performing user trials include ISO 6658, ISO 9999, ISO 11948-1, and ISO 16021. ISO 2017 All rights reserved vBS EN ISO 15621:2017This page deliberately left blankAbsorbent incontinence aids for urine and/or faeces General guidelines on evaluation1 ScopeThis document gives guidelines for evaluating a

35、bsorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.2 Normative referencesThere are no normative

36、references in this document.3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at http:/www.iso.org/obp IEC El

37、ectropedia: available at http:/www.electropedia.org/3.1 General terms3.1.1absorbent incontinence aidproduct containing absorbent material to absorb urine and/or absorb/contain faeces when the wearer is suffering incontinence3.1.2absorption capacityamount of liquid that can be absorbed by an absorben

38、t incontinence aid (3.1.1) under specified conditions 3.1.3acquisition speedtime taken for a specified amount of liquid to be absorbed into an absorbent incontinence aid (3.1.1) under specified conditions3.1.4end userperson who uses an absorbent incontinence aid (3.1.1)3.1.5carerperson or organizati

39、on who helps someone to perform their tasks of daily living, such as managing their incontinence3.1.6retention capacityamount of liquid that is retained by an absorbent incontinence aid (3.1.1) after all unbound liquid has been removed under specified conditionsINTERNATIONAL STANDARD ISO 15621:2017(

40、E) ISO 2017 All rights reserved 1BS EN ISO 15621:2017ISO 15621:2017(E)3.1.7rewetamount of surplus that escapes from an absorbent incontinence aid (3.1.1) when it is exposed to external forces or pressure under specified conditions3.2 Product types3.2.1all-in-onebriefslipabsorbent incontinence aid (3

41、.1.1) in which the absorbent core is mounted within a chassis, equipped with re-adjustable fixation system, which allows it to be secured to the body without the help of additional fixation systemsNote 1 to entry: An all-in-one usually has elastics surrounding the leg shape and self-adhesive tapes.

42、3.2.2belted productabsorbent incontinence aid (3.1.1) in which the absorbent core is mounted within a chassis, equipped with re-adjustable waist belt 3.2.3padinsertlinershieldabsorbent incontinence aid (3.1.1) held in place by elastic mesh briefs or to be used inside another absorbent product to sup

43、plement absorption capacity (3.1.2) Note 1 to entry: There is a wide range of pads designed for different amounts of urine leakage. Some products are designed mainly for urine leakage while others are designed also for faecal leakage. 2 ISO 2017 All rights reservedBS EN ISO 15621:2017ISO 15621:2017(

44、E)3.2.4pad for underwearfemale padmale padabsorbent incontinence aid (3.1.1) to be placed in underwear with, for example, an adhesive stripNote 1 to entry: Compared to pad/insert/liner/shield (3.2.3) pads for underwear are usually smaller products, often with gender-specific shape and designed for l

45、ower amount of urine. 3.2.5pull-onpantsprotective underweardisposable underwearabsorbent incontinence aid (3.1.1) shaped and designed to resemble normal underwear designed especially for male or female users or as unisex productsNote 1 to entry: A pull-on can be applied like a normal underwear. ISO

46、2017 All rights reserved 3BS EN ISO 15621:2017ISO 15621:2017(E)4 Evaluation requirements4.1 GeneralThe details of how an evaluation is conducted and the factors that it needs to focus on will vary depending on, for example, the needs and priorities of the end users, their caregivers, the organizatio

47、n providing the products, etc. It will also depend on the purpose of the evaluation: for example, if the priority is to exclude poorly performing products, or to distinguish between products with broadly similar characteristics, the specific questions will differ.But, whatever the nature and purpose

48、 of an evaluation, the factors to be considered can be usefully divided into the three groups: user-related factors (see 4.2), product-related factors (see 4.3), and usage-related factors (see 4.4).NOTE It can be helpful to prepare for an evaluation by consulting the international classification ISO

49、 9999:2016, Code 09 302.4.2 User-related factors4.2.1 GeneralThe needs of the individual end user are of utmost importance and, therefore, should always be the primary focus when evaluating products.The following is a list of key assessment factors related to the end user as discussed in Reference 9. These assessment factors provide perspectives on how absorbent incontinence aids can benefit the end user.4.2.2 Quality of lifeAll forms of incontinence can cause isolation, depression and physiological problems and can significantly