§ 1270.2 Requirements for adult portable bed rails. ( a ) Except as provided in paragraph (b) of this section, each adult portable bed rail must comply with all applicable provisions of ASTM F3186-17, *Standard Specification for Adult Portable Bed Rails and Related Products,* approved on August 1, 2017. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This incorporation by reference (IBR) material is available for inspection at the U.S. Consumer Product Safety Commission and at the National Archives and Records Administration (NARA). Contact the U.S. Consumer Product Safety Commission at: Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814, telephone (301) 504-7479, email *cpsc-os@cpsc.gov .* For information on the availability of this material at NARA, email *fr.inspection@nara.gov ,* or go to: *www.archives.gov/federal-register/cfr/ibr-locations.html .* A read-only copy of the standard is available for viewing on the ASTM website at *https://www.astm.org/READINGLIBRARY/ .* You may obtain a copy from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959; telephone (610) 832-9585; *www.astm.org .*
( b ) Comply with the ASTM F3186-17 standard with the following changes: ( 1 ) In addition to complying with the definitions in section 3.1 of ASTM F3186-17, comply with the following definitions: ( i ) *Entrapment zone.* An area, gap, or opening that can potentially capture or restrain a person's body part. Hazardous openings may not always be visible prior to testing.
( ii ) *Initial assembly.* The first assembly of the product components after purchase, and prior to installing on the bed.
( iii ) *Initial installation.* The first installation of the product onto a bed or mattress.
( iv ) *Installation component.* Component(s) of the bed rail that is/are specifically designed to attach the bed and typically located under the mattress when in the manufacturer's recommended use position.
( 2 ) Instead of complying with section 6.1.3 of ASTM F3186-17, comply with the following: ( i ) Permanently attached retention system components shall not be able to be removed without the use of a tool after initial assembly.
( ii ) [Reserved]
( 3 ) In addition to complying with section 6.2.1 of ASTM F3186-17, comply with the following: ( i ) The test personnel shall choose a mattress and product setting configuration that results in the most severe condition per test requirement (see paragraph (b)(8)(i) of this section).
( ii ) [Reserved]
( 4 ) Instead of complying with section 6.3.3 of ASTM F3186-17, comply with the following: ( i ) *Zone 3.* When tested in accordance with section 8.4.5 of ASTM F3186-17, the horizontal centerline on the face of the 4.7 in (120 mm) end of the test probe (see paragraph (b)(9)(i) of this section) shall be above the highest point of the uncompressed mattress.
( ii ) [Reserved]
( 5 ) Instead of complying with section 6.4.1 of ASTM F3186-17, comply with the following: ( i ) Holes or slots that extend entirely through a wall section of any rigid material less than 0.375 in (9.53 mm) thick and admit a 0.210 in (5.33 mm) diameter rod shall also admit a 0.375 in (9.53 mm) diameter rod. Holes or slots that are between 0.210 in (5.33 mm) and 0.375 in (9.53 mm) and have a wall thickness less than 0.375 in (9.53 mm) but are limited in depth to 0.375 in (9.53 mm) maximum by another rigid surface shall be permissible (see Opening Example in Figure 2 of ASTM F3186-17).
( ii ) [Reserved]
( 6 ) Instead of complying with section 6.5.1 of ASTM F3186-17, comply with the following: ( i ) Any structural components and retention system components of a product covered by this specification that require consumer assembly or adjustment, or components that may be removed by the consumer without the use of a tool, shall not be able to be misassembled when evaluated to (see paragraph (b)(7)(i) of this section).
( ii ) [Reserved]
( 7 ) Instead of complying with section 6.5.2 of ASTM F3186-17, comply with the following: ( i ) *Determining misassembled product.* A product covered by this specification shall be considered misassembled if it appears to be functional under any condition and it does not meet the requirements of sections 6.1 through 6.4 of ASTM F3186-17.
( ii ) [Reserved]
( 8 ) In addition to complying with section 7.1 of ASTM F3186-17, comply with the following: ( i ) Mattress thickness ranges used for testing shall be up to 1.5 in. (38 mm) larger or smaller than the range specified by the manufacturer. Test personnel shall choose a mattress and product setting configuration that provide the most severe condition for each test requirement in the standard. Note 1 to paragraph (b)(8)(i):
The technology and consumer preferences for bedding are highly variable and continuously changing. Therefore, they cannot be reasonably accounted for within this standard. Test facilities and personnel should consider current bedding trends and all types of mattresses that may foreseeably be used with the product when making a test mattress selection.
( ii ) [Reserved]
( 9 ) Instead of complying with section 7.2 of ASTM F3186-17, comply with the following: ( i ) *Entrapment test probe.* The test probe used for the entrapment tests shall be as described in the Food and Drug Administration (FDA) Guidance Document, “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment,” which can be found at: *www.fda.gov/regulatory-information/search-fda-guidance-documents/hospital-bed-system-dimensional-and-assessment-guidance-reduce-entrapment .* The test probe can be independently manufactured per the dimensional constraints in the guidance document or purchased from Bionix, 5154 Enterprise Blvd., Toledo, OH 43612, 800-551-7096, *www.bionix.com .* Videos illustrating use of the test probe are available at: *www.youtube.com/c/BionixLLC/search .*
( ii ) [Reserved]
( 10 ) Substitute the following text as the content of Note 1 in section 8.4 of ASTM F3186-17: ( i ) The tests described in this section are similar to those described in the referenced FDA Guidance Document.
( ii ) [Reserved]
( 11 ) Instead of complying with section 8.4.3.4 of ASTM F3186-17, comply with the following: ( i ) If the test probe does not pull through freely, attach the force gauge and exert a 22.5 lbf (100 N) pulling force to the 2.4 in (60 mm) cylindrical end of the entrapment test probe in the direction most likely to lead to failure of the requirement. If the 4.7 in (120 mm) end of the cone does not enter any of the openings, this space passes the test. If the 4.7 in (120 mm) end of the test probe cone does enter any of the openings, this space fails the test.
( ii ) [Reserved]
( 12 ) Instead of complying with section 8.4.4.3 of ASTM F3186-17, comply with the following: ( i ) Insert the 2.4 in (60 mm) end of the cone into the opening at the angle most likely to allow it to pass through. Insert the cone into the opening until it is in full contact with the product. The mattress shall only be compressed by the weight of the cone.
( ii ) [Reserved]
( 13 ) Instead of complying with section 8.4.4.4 of ASTM F3186-17, comply with the following: ( i ) If the test probe does not pull through freely use the force gauge to exert a 22.5 lbf (100 N) pulling force to the 2.4 in (60 mm) cylindrical end of the cone in the direction most likely to lead to failure of the requirement.
( ii ) [Reserved]
( 14 ) In addition to complying with section 8.4.4 of ASTM F3186-17, comply with the following: ( i ) If a horizontal section of the rail greater than 4.7 in exists along the bottom of the rail, that section must also meet the Zone 2 requirements regardless of the number or location of the supports. Repeat testing described in section 8.4.4.3 of ASTM F3186-17 (see paragraph (b)(12)(i) of this section) and section 8.4.4.4 of ASTM F3186-17 (see paragraph (b)(13)(i) of this section) for all applicable entrapment zones. Figure 1 to this paragraph (b)(14)(i) shows a general example of areas subject to Zone 2 requirements. Figure 1 to paragraph (b)(14)(i)—General Example of Areas Subject to Zone 2 Requirements
( ii ) [Reserved]
( 15 ) Instead of complying with section 8.4.5.4 of ASTM F3186-17, comply with the following: ( i ) Turn the cone until the line on the face of the 4.7 in (120 mm) end is horizontal and let the cone sink into the space by its own weight. ( A ) If the line on the face of the 4.7 in (120 mm) end of the cone is above the highest point of the uncompressed mattress, as shown in Figure 2 to this paragraph (b)(15)(i), the space passes the test.
( B ) If the line on the face of the 4.7 in (120 mm) end of the cone is at or below the highest point of the uncompressed mattress, as shown in Figure 2 to this paragraph (b)(15)(i), the space fails the test. Figure 2 to paragraph (b)(15)(i)—Zone 3 Test: (a) Pass, (b) Fail
( ii ) [Reserved]
( 16 ) In addition to complying with section 8.6.3 of ASTM F3186-17, use the following definition: ( i ) The “free end” is defined as the location on the retention system that is designed to produce a counter force; it may be a single distinct point or a location on a loop.
( ii ) [Reserved]
( 17 ) Instead of complying with section 9.1.1.3 of ASTM F3186-17, comply with the following: ( i ) That the product is to be used only with the type and size of mattress and bed, including the range of thickness of mattresses, specified by the manufacturer of the product. If beds with head or footboards are allowed, the distance between the head or footboard and the placement of the product shall be indicated to be >12.5 in (318 mm).
( ii ) [Reserved]
( 18 ) Instead of complying with section 9.2.5 of ASTM F3186-17, comply with the following: ( i ) Each product's retail package and instructions shall include the warning statements in Figure 3 to this paragraph (b)(18)(i). Figure 3 to paragraph (b)(18)(i)—Warning Statements for Product Retail Package and Instruction
( ii ) [Reserved]
( 19 ) Instead of complying with section 9.2.7 of ASTM F3186-17, comply with the following: ( i ) At least one installation component of the product must be labeled with the entrapment warning in Figure 4 to this paragraph (b)(19)(i). Figure 4 to paragraph (b)(19)(i)—Entrapment Warning
( ii ) [Reserved]
( 20 ) Instead of complying with section 11.1.1.3 of ASTM F3186-17, comply with the following: ( i ) In addition to contacting the manufacturer directly, consumers can report problems to the CPSC at its website SaferProducts.gov or call 1-800-638-2772.
( ii ) [Reserved]