BS ISO 16840-6-2015 Wheelchair seating Simulated use and determination of the changes in properties of seat cushions《轮椅座椅 座椅垫性能变化的模拟使用和测定》.pdf

1、BSI Standards PublicationBS ISO 16840-6:2015Wheelchair seatingPart 6: Simulated use and determination of the changes in properties of seat cushionsBS ISO 16840-6:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 16840-6:2015. The UK participation in its prep

2、aration was entrusted to TechnicalCommittee CH/173/1, Wheelchairs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applicati

3、on. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 82446 3 ICS 11.180.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Commit

4、tee on 30 September 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 16840-6:2015 ISO 2015Wheelchair seating Part 6: Simulated use and determination of the changes in properties of seat cushionsSiges de fauteuils roulants Partie 6: Simulation dutilisation et dter

5、mination des changements de proprits des coussins de sigesINTERNATIONAL STANDARDISO16840-6First edition2015-09-15Reference numberISO 16840-6:2015(E)BS ISO 16840-6:2015ISO 16840-6:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved.

6、 Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at

7、the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 16840-6:2015ISO 16840-6:2015(E)Foreword viIntroduction vii1 Scope . 12 No

8、rmative references 13 Terms and definitions . 14 Symbols and abbreviated terms . 55 Apparatus for characterizing and ageing cushions 55.1 Apparatus for characterizing cushions 55.2 Apparatus for aging cushions . 66 Test environment . 77 Preparation and setup of cushion 78 Selection and order of test

9、ing . 78.1 Testing consists of three stages 79 Envelopment . 89.1 Rationale. 89.2 Test method and reporting . 810 Column buckling . 810.1 Rationale. 810.2 Test method . 910.3 Method of calculation 910.4 Test report . 911 Heat and humidity 911.1 Rationale. 911.2 Test method . 911.3 Method of calculat

10、ion . 1011.4 Test report 1012 Heated indenter compression set 1112.1 Rationale 1112.2 Test method 1112.3 Method of calculation . 1112.4 Test report 1113 Impact damping under normal conditions 1213.1 Rationale 1213.2 Test method 1214 Interface pressure measurement test (pressure mapping) .1214.1 Rati

11、onale 1214.2 Test method 1214.3 Method of calculation . 1214.4 Test report 1315 Lateral stiffness.1315.1 Rationale 1315.2 Test method 1315.3 Method of calculation . 1415.4 Test report 1416 Leak .1416.1 Rationale 1416.2 Test method 14 ISO 2015 All rights reserved iiiContents PageBS ISO 16840-6:2015IS

12、O 16840-6:2015(E)16.3 Test report 1417 Loaded contour depth and overload deflection 1417.1 Rationale 1417.2 Test method 1517.3 Method of calculation . 1518 Hysteresis test 1518.1 Rationale 1518.2 Test method 1519 Sliding resistance 1519.1 Rationale 1519.2 Test method 1519.3 Method of calculation . 1

13、519.4 Test report 1620 10 % force deflection 1620.1 Rationale 1620.2 Test method 1620.3 Method of calculation . 1621 Stage 2: Simulated age testing .1622 Accelerated aging 1722.1 Rationale 1722.2 Test method 1722.2.1 70 C accelerated aging procedure 1722.2.2 50 C modified accelerated aging procedure

14、 (for cushions made with hydrogels or other materials not intended for high temperature exposure) .1822.3 Method of calculation . 1822.4 Test report 1823 Bacterial soiling 1823.1 Rationale 1823.2 Test method 1823.2.1 Preparation of bacterial soiling broth 1823.2.2 Bacterial exposure .1923.3 Method o

15、f calculation . 1923.4 Test report 1924 Cold exposure .2024.1 Rationale 2024.2 Test method 2024.3 Method of calculation . 2024.4 Test report 2025 Cyclic loading at elevated temperature2025.1 Rationale 2025.2 Test method 2025.3 Method of calculation . 2125.4 Test report 2126 Disinfection .2126.1 Rati

16、onale 2126.2 Test method 2126.2.1 Cover of cushion disinfection . 2126.2.2 Interior cushion disinfection 2127 Faecal soiling with cyclic loading .2227.1 Rationale 2227.2 Test method 2227.3 Method of calculation . 2227.4 Test report 22iv ISO 2015 All rights reservedBS ISO 16840-6:2015ISO 16840-6:2015

17、(E)28 Heat and humidity .2228.1 Rationale 2228.2 Test method 2328.3 Method of calculation . 2328.4 Test report 2329 Laundering 2329.1 Rationale 2329.2 Test method 2329.2.1 Cover of cushion laundering . 2329.2.2 Interior cushion laundering 2329.3 Method of calculation . 2329.4 Test report 2330 Urinar

18、y soiling with cyclic loading .2430.1 Rationale 2430.2 Test method 2430.3 Method of calculation . 2430.4 Test report 2431 UV and ozone exposure 2431.1 Rationale 2431.2 Test method 2431.3 Method of calculation . 2531.4 Test report 2532 Stage 3: Post-aged cushion testing 2533 Method of calculations 25

19、34 Test report 26Annex A (informative) Influences that drive changes in seat cushion performance.27Bibliography .28 ISO 2015 All rights reserved vBS ISO 16840-6:2015ISO 16840-6:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bod

20、ies (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 established has the right to be represented on that committee. International organization

21、s, 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.The procedures used to develop this document and those intended for its further

22、maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed 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).

23、 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. 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 Introd

24、uction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to co

25、nformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 173, Assistive products for persons with disability, Subcom

26、mittee SC 1, Wheelchairs.ISO 16840 consists of the following parts, under the general title Wheelchair seating: Part 1: Vocabulary, reference axis convention and measures for body segments, posture and postural support surfaces Part 2: Determination of physical and mechanical characteristics of devi

27、ces intended to manage tissue integrity Seat cushions Part 3: Determination of static, impact and repetitive load strengths for postural support devices Part 4: Seating systems for use in motor vehicles Part 6: Simulated use and determination of the changes in properties of seat cushions Part 9: Cli

28、nical interface pressure mapping guidelines for seating Technical Report Part 10: Resistance to ignition of non-integrated seat and back support cushions Part 10: Requirements and test methods Part 11: Determination of perspiration dissipation characteristics of seat cushions intended to manage tiss

29、ue integrity Technical Specification Part 12: Apparatus and method for cushion envelopment testing Technical SpecificationFuture parts dealing with methods for determining heat and water vapour characteristics and clinical guidelines for the measurement of postural support surfaces and body segments

30、 are planned.vi ISO 2015 All rights reservedBS ISO 16840-6:2015ISO 16840-6:2015(E)IntroductionWheelchair seat cushions provide improved support and injury prevention for the user. They are used by those with a variety of needs and by those with varying degrees of disability. Wheelchair seat cushions

31、 are prescribed based on their ability to perform under a range of circumstances, from intermittent use to robust sports use, and use by those with regular incontinence. Each application presents different conditions that can change the performance of the cushion and can expose the user to hidden ri

32、sks. Standards for the evaluation of wheelchair cushions under a wide range of conditions are paramount.This part of ISO 16840 describes test methods that characterize the changes in physical and mechanical properties of seat cushions based on their age and use. The standard offers a suite of test m

33、ethods, not all of which will be appropriate for all cushions, and therefore, the manufacturer is to determine which are appropriate for their cushion construction and use. It is designed to provide a close approximation of the changes that have been observed to occur over time. The protocol consist

34、s of performing tests to characterize the properties of a new cushion, subjecting the cushion to multiple simulated aging processes, then re-testing the cushion proprieties. Changes that occur are reported.Prior to following the protocol, the manufacturer is to recommend the environment of use of th

35、e cushion, the anticipated failure modes of the cushion, and the cushion characterization tests appropriate for their product. Just as not all tests are appropriate for all cushions, the exposures within the tests might not be appropriate for all cushions. Tests may be modified or eliminated based o

36、n suitability for materials, architecture, or use conditions, i.e. a rotational component could be added to the cyclic loading, generating additional wear. For some materials, 70 C can change the failure mode from typical to temperature-based, depending on the material properties of this cushion. In

37、 such a case, 50 C may be selected to accelerate the aging of the cushion over a longer period of time to simulate a failure more typical of aging. Any deviations are to be documented.These tests are not appropriate for ranking or scoring cushions or for directly matching these characteristics with

38、the requirements of individual users. While the results of these tests can aid the clinician in providing care to the patient through selection of surface characteristics that will, in their professional judgment, aid the care, treatment, or recovery of the patient, these tests are not to be interpr

39、eted as prescriptive in and of themselves. The link to clinical efficacy, although implied, has not been validated. It is intended that this part of ISO 16840 will evolve when clinical relevance is confirmed. Further parts of the ISO 16840 series will describe test methods for characterizing other s

40、urface characteristics that can further aid the clinician in the care and treatment of patients. ISO 2015 All rights reserved viiBS ISO 16840-6:2015BS ISO 16840-6:2015Wheelchair seating Part 6: Simulated use and determination of the changes in properties of seat cushions1 ScopeThis part of ISO 16840

41、 specifies apparatus, test methods, and disclosure requirements for generating aging effects in a seat cushion that reproduce those seen in use. It also provides methods of determining changes in the physical and mechanical properties of seat cushions based on their age and use. This part of ISO 168

42、40 provides a set of tests that simulate wear and tear, which can be useful to validate warranty claims and to provide information about product, life, and performance limitations associated with product use.2 Normative referencesThe following documents, in whole or in part, are normatively referenc

43、ed in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 554, Standard atmospheres for conditioning and/or testing SpecificationsI

44、SO 4892-3, Plastics Methods of exposure to laboratory light sources Part 3: Fluorescent UV lampsISO 9073-8, Textiles Test methods for nonwovens Part 8: Determination of liquid strike-through time (simulated urine)ISO 16840-2, Wheelchair seating Part 2: Determination of physical and mechanical charac

45、teristics of devices intended to manage tissue integrity Seat cushionsASTM D5672-09, Standard Test Method for Testing Flexible Cellular Materials Measurement of Indentation Force Deflection Using a 25-mm (1-in.) Deflection TechniqueAAMI TIR 12, Designing, testing, and labeling reusable medical devic

46、es for reprocessing in health care facilities: A guide for medical device manufacturersASTM D39503, Standard Test Methods for Rubber Property Compression SetASTM D4265-98, Standard Guide for Evaluating Stain Removal Performance in Home LaunderingASTM F1980-2, Standard Guide for Accelerated Aging of

47、Sterile Medical Device PackagesISO/IEC Guide 98-3, Uncertainty of measurement Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)RESNA SS-1:2011 Section 3, Standard Protocol for Measuring Heat and Water Vapor Dissipation Characteristics of Full Body Support Surfaces Body Analog

48、Method3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 16840-2 and the following apply.INTERNATIONAL STANDARD ISO 16840-6:2015(E) ISO 2015 All rights reserved 1BS ISO 16840-6:2015ISO 16840-6:2015(E)3.1accelerated agingprocedure to simulate normal usage

49、 by subjecting a product to stresses that are more severe or more frequent than normal environmental or operational stresses3.2ballooningpillow effect created when air is trapped within a shrinking bag3.3bacterial enzymatic action failurefailure due to bacterial enzymatic action Note 1 to entry: See failure (3.17).3.4broken seamsseparation of a welded or sewn seam or the material immediately adjacent to seamNote 1 to entry: May be a cosmetic change or a failure.3.5bucklingcollapsing of the material due to pres