ASTM F3186-2017 Standard Specification for Adult Portable Bed Rails and Related Products《成人便携式床栏和相关产品的标准规格》.pdf

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1、Designation: F3186 17Standard Specification forAdult Portable Bed Rails and Related Products1This standard is issued under the fixed designation F3186; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A nu

2、mber in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This safety specification establishes performance re-quirements for adult portable bed rails, related products, andadult portable bedrail

3、 accessories, including requirements forresistance to entrapment, marking and adhered labels, instruc-tional literature, and advertising.1.2 This standard is applicable to any such product (asdefined below) that is not designed as part of the bed by the bedmanufacturer, and is installed on, against

4、or adjacent to the sideof an adult bed and is for use by adults to reduce the risk offalling from the bed, assist in repositioning in the bed, assist intransitioning into or out of the bed, or other similar purposes asstated by the manufacturer.1.3 This safety specification includes adult portable b

5、edrails that meet the definition of a medical device and aretherefore under the jurisdiction of the Food and Drug Admin-istration (FDA), and adult portable bed rails that are notmedical devices, and which therefore fall under the jurisdictionof the Consumer Product Safety Commission (CPSC).21.4 This

6、 safety specification does not cover guardrails orside rails intended for use on FDA regulated hospital beds, orportable rails for children which are included in ConsumerSafety Specification F1821 for toddler beds, Consumer SafetySpecification F2085 for portable bed rails for children, or IEC60601-2

7、-52 for medical beds.1.5 This safety specification is intended to minimize entrap-ment and strangulation hazards that are attributed to designcomponents, whether these hazards arise from normal instal-lation and use, reasonably foreseeable mis-installation/misuse,or changes to the stability of the a

8、ttachment over time, orcombinations thereof. Other hazards may exist (for example,falls) that are not within the scope of this specification. Suchhazards will be the subject of additional standards.1.6 No adult portable bed rail, or related product as definedin this specification, shall, either by l

9、abel or other means,indicate compliance with this specification unless it conformsto all the requirements contained herein.1.7 UnitsThe values stated in inch-pound units are to beregarded as standard. The values given in parentheses aremathematical conversion to SI units that are provided forinforma

10、tion only and are not considered standard.1.8 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety, health and environmental practices and deter-mine the applicabili

11、ty of regulatory limitations prior to use.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the Wor

12、ld Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:3D3359 Test Methods for Rating Adhesion by Tape TestF1821 Consumer Safety Specification for Toddler BedsF2085 Consumer Safety Specification for Portable Bed Rails2.2 Federal Standards and Guide

13、lines:416 CFR 1500.48 Technical Requirements for Determining aSharp Point in Toys and Other Articles Intended for Useby Children Under 8 Years of Age16 CFR 1500.49 Technical Requirements for Determining aSharp Metal or Glass Edge in Toys and Other ArticlesIntended for Use by Children Under 8 Years o

14、f Age2.3 Other Standards:IEC 60601-2-52 Medical Electrical Equipment Part 2-52:Particular Requirements for the Basic Safety and EssentialPerformance of Medical Beds51This specification is under the jurisdiction of ASTM Committee F15 onConsumer Products and is the direct responsibility of Subcommitte

15、e F15.70 onAdult Safety Products.Current edition approved Aug. 1, 2017. Published August 2017. DOI: 10.1520/F3186-17.2See “Is The Product a Medical Device?”, www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm.3For referenced ASTM standards, visit the AST

16、M website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from U.S. Government Printing Office, Superintendent ofDocuments, 732 N. Capitol St., NW, Washi

17、ngton, DC 20401-0001, http:/www.access.gpo.gov.5Available from International Electrotechnical Commission (IEC), 3, rue deVaremb, 1st Floor, P.O. Box 131, CH-1211, Geneva 20, Switzerland, http:/www.iec.ch.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-29

18、59. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical

19、Barriers to Trade (TBT) Committee.1ANSI Z535.4 American National Standard for ProductSafety Signs and Labels63. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 adult portable bed rail, nan adjacent type bed rail,grab bar, assistive bar, transfer aid, cane or rail (henceforthident

20、ified as the product or products) intended by the manu-facturer to be installed on, against, or adjacent to an adult bed.The product may vary in lengths (for example, full, half, orpartial rails, grab bar or handle or transfer post or pole), and isintended by the manufacturer to provide assistance t

21、o the bedoccupant in moving on the bed surface, in entering or exitingthe bed, to minimize the possibility of falling out of bed, or forother similar purposes. This includes similar products that arelikely to be used for these purposes even if this is not explicitlystated by the manufacturer. Howeve

22、r, the standard does notaddress ALL products that might be so used, for example, achair.3.1.2 adjacent type bed rail, na portable bed rail or relatedproduct in which the guard portion (portion that an adult wouldcontact when rolling toward the mattress edge) is essentially avertical plane or pole th

23、at is positioned against the side of themattress.3.1.3 conspicuous, adjvisible, when the product is in themanufacturers recommended use position, to a person stand-ing near the unit at any one position around the unit but notnecessarily visible from all positions.3.1.4 consumer adjustment, nthose ac

24、tivities defined bythe instructions to be taken by the installer in order to properlyfit and secure the product to the mattress and bed structure.3.1.5 hazardous condition, nproduct design or arrange-ment between product, mattress, and accessories that is likelyto create a condition that is likely t

25、o cause death or seriouspersonal injury to persons exposed to such conditions.3.1.6 mattress topper, na soft cushion that sits on top orencloses a beds mattress that is used to make the existingmattress more comfortable and may be made of an egg cratefoam, memory or visco-elastic foam, poly fibers,

26、feathers, orother materials3.1.7 retention system, nthose parts of the product thatserve to keep the product in place when installed in accordancewith the instructions for use.4. Test Set-up Requirements4.1 The product shall be completely assembled in accor-dance with the instructions for use, unles

27、s otherwise noted inthe tests below.4.2 No testing shall be conducted within 48 h of manufac-turing.4.3 The product to be tested shall be in a room with anambient temperature of 73 6 9F (23 6 5C) for at least 1 hprior to testing. Testing shall then be conducted within thistemperature range.4.4 All t

28、esting required by this specification shall be con-ducted on the same unit.5. General Requirements5.1 There shall be no hazardous sharp point or edges asdefined by 16 CFR 1500.48 and 16 CFR 1500.49.5.2 Any exposed parts shall be smooth and free from roughor jagged surfaces.5.3 Products covered by th

29、is specification that can beinstalled on a bed that articulates shall meet all of theperformance requirements in Section 6 when the bed is in theflat and articulated positions and shall be assessed for risk ofentrapment as specified in Section 8.6. Performance Requirements6.1 Retention Systems:6.1.1

30、 All products shall include a method for maintainingthe installed product in a position for which the product willcontinue to perform to the test methods in Section 8 withoutrequiring readjustment of any components. Some movement ofproduct or mattress is acceptable as long as it does not lead tofail

31、ure to meet the tests in Section 8.6.1.2 The retention system shall be permanently attached tothe product, as described in 6.1.3, by the manufacturer or bythe consumer during the initial assembly.6.1.3 Permanently attached retention system componentsshall not be able to be removed without the use of

32、 a tool afterinitial installation.6.1.4 Retention system components shall not allow theretention system to slip when tested in accordance with theentrapment tests in Section 8.6.1.5 Straps:6.1.5.1 Any straps used to attach the product to the bed mustbe shown to allow for the product to continue to m

33、eet the testrequirements under the forces used for attachment and adjust-ment when tested in accordance with 8.6.6.1.5.2 After initial assembly the straps shall require the useof a tool for removal.6.2 Structural Integrity:6.2.1 When installed using the thickest mattress recom-mended by the product

34、manufacturer, the top of the productshall extend at least 4.0 in. (101.6 mm) above the top surfaceof the mattress.6.2.2 After testing in accordance with 8.1 8.3, there shallbe no changes in dimensions or hazardous condition created asdefined in Section 5.6.3 EntrapmentProducts shall be tested with r

35、espect toeach applicable Zone (Fig. 1) in accordance with Section 8.These zones are described in the cited FDA Guidance7(seeAppendix X1 for further details). Fig. 1 is similar to that usedin the FDA Guidance. Adult portable bed rail products vary inshape, design, and use. Therefore, this figure serv

36、es as a6Available from American National Standards Institute (ANSI), 25 W. 43rd St.,4th Floor, New York, NY 10036, http:/www.ansi.org.7See Hospital Bed System Dimensional and Assessment Guidance to ReduceEntrapment (issued March 10, 2006), US Food and Drug Administration, http:/www.fda.gov/MedicalDe

37、vices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072662.htm.F3186 172reference for zone or areas of entrapment for a portable bedrails, but the actual shapes and sizes of products could bedifferent from Fig. 1.6.3.1 A bed rail type product is shown in Fig. 1. Other bedrails and products covere

38、d by this specification may not haveone or more of the indicated entrapment zones and testing shallbe adjusted accordingly, for example a product without pen-etrating openings will not have Zone 1. However, if the arearepresented by a zone is present, that area must pass theapplicable test. Most pro

39、ducts will have an area at each endindicated by Zone 4.6.3.2 Zones 12The test probe (see 7.2 for discussion ofthe test probe) shall not pass completely through the openingwhen tested according to 8.4.3 and 8.4.4.6.3.3 Zone 3The highest point on the cylinder of the testprobe (see 7.2) shall not pass

40、completely below the horizontaluncompressed plane of the mattress when tested according to8.4.5.6.3.4 Zone 4The test probe shall not pass completelythrough the opening or touch the product in the red area of thetest probe when tested according to 8.4.6.6.4 Openings:6.4.1 Holes or slots that extend e

41、ntirely through a wallsection of any rigid material less than14 in. (6.35 mm) thickand admit a58 in. (13 mm) diameter rod shall also admita1in.(25.4 mm) diameter rod. Holes or slots that are between 8 mmand 25 mm and have a wall thickness less than14 in. (6.35 mm)but are limited in depth to14 in. (6

42、.35 mm) maximum byanother rigid surface shall be permissible (see Fig. 2).6.5 Misassembled Products:6.5.1 Any structural components and retention system com-ponents of a product covered by this specification that requiresconsumer assembly shall not be able to be misassembled whenevaluated to 6.5.2.6

43、.5.2 Determining Misassembled Product: A product cov-ered by this specification shall be considered misasssembled ifit appears to be functional under any condition and it does notmeet the requirements of 6.1 6.4.7. Test Equipment:7.1 Test Platform:7.1.1 Mattress and Mattress SupportTesting shall be

44、con-ducted on each mattress and mattress support and type of bedthat the manufacturer specifies as suitable for use with theirproduct.7.1.2 Products intended by the manufacturer to be used onarticulating type bed systems shall be tested using the recom-mended system. Testing shall be performed with

45、the mattressoriented in the flat position and in the articulated positions thatpresent the greatest risk of entrapment as determined by thetester.7.2 Entrapment Test ProbeThe test probe shall be asdescribed in the FDA Guidance Document “Hospital BedSystem Dimensional and Assessment Guidance to Reduc

46、eEntrapment” which can be found at http:/www.fda.gov/MedicalDeviceRegulationandGuidance/GuidanceDocuments/ucm072662. The test probe can be independentlymanufactured, or it can be purchased from NST Sales to report problemsor injuries, call 18003321088” or “This product is underthe jurisdiction of th

47、e CPSC; to report problems or injuries, goto www.SaferProducts.gov or call 18006382772.9.2 Warning Statements Each Product Shall Have Warn-ing Statements:9.2.1 The warnings shall be easy to read and understand andbe in the English language at a minimum.An example is shownin Fig. 4.9.2.2 Any labels o

48、r written instructions provided in additionto those required by this section shall not contradict or confusethe meaning of the required information, or be otherwisemisleading to the consumer.9.2.3 The warning labels on the product shall beconspicuous, in highly contrasting color(s) (for example, bla

49、cktext on white background), in non-condensed sans serif type,and permanent.9.2.4 Each group of warning statements shall be precededby the safety alert symbol “ ” and the exact signal wordspecified in the warning statements (for example, “WARN-ING”). The safety alert symbol and the signal words shall notbe less than 0.20 in. (5 mm) high, and the remainder of the textshall be characters whose upper case shall be at least 0.12 in.(3.0 mm) high, except where otherwise specified.F3186 175NOTE 2For additional guidance on the design of warnings,