16 C.F.R. § 1242.5

Current through October 31, 2024
Section 1242.5 - [Effective 4/23/2025] Test methods
(a)Test conditions.
(1) Condition the product for 48 hours at 23 °C +/-2 °C (73.4 °F +/-3.6 °F) and a relative humidity of 50% +/-5%.
(2) Secure the firmness fixture to a test base such that the 3-in. head probe (figure 1 to § 1242.4(a)) does not deflect more than 0.01 in. (0.025 cm) under a 10 N (2.2 lb) load applied in each orientation required in the test methods.
(b)Removal of components test method -
(1)Equipment. For torque and tension tests, any suitable device may be used to grasp the component, provided that it does not interfere with the attachment elements that are stressed during the tests.
(2)Torque test. Gradually apply a 4 lb-in. (0.4 N-m) torque over 5 seconds (s.) in a clockwise rotation to 180 degrees or until 4 lb-in. has been reached. Maintain for 10 s. Release and allow component to return to relaxed state. Repeat the torque test in a counterclockwise rotation.
(3)Tension test. For components that can reasonably be grasped between thumb and forefinger, or teeth, apply a 15 lb (67 N) force over 5 s., in a direction to remove the component. Maintain for 10 s. A clamp such as shown in figure 1 to this paragraph (b)(3) may be used if the gap between the back of the component and the base material is 0.04 in. (0.1 cm) or more.

Figure 1 to Paragraph (b)(3)-Tension Test Adapter Clamp

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(c)Permanency of labels and warnings.
(1) A paper label (excluding labels attached by a seam) shall be considered permanent if, during an attempt to remove it without the aid of tools or solvents, it cannot be removed, it tears into pieces upon removal, or such action damages the surface to which it is attached.
(2) A non-paper label (excluding labels attached by a seam) shall be considered permanent if, during an attempt to remove it without the aid of tools or solvents, it cannot be removed or such action damages the surface to which it is attached.
(3) A warning label attached by a seam shall be considered permanent if it does not detach when subjected to a 15-lbf (67-N) pull force applied in the direction most likely to cause failure using a 3/4 -in. (1.9 cm) diameter clamp surface. Gradually apply the force within a period of 5 s. and maintain for an additional 10 s.
(4) Adhesion Test for Warnings Applied Directly onto the Surface of the Product:
(i) Apply the tape test defined in Test Method B of ASTM D3359-23 (incorporated by reference, see § 1242.8), eliminating parallel cuts.
(ii) Perform this test once in each different location where warnings are applied.
(iii) The warning statements will be considered permanent if the printing in the area tested is still legible and attached after being subjected to this test.
(5) A non-paper label, during an attempt to remove it without the aid of tools or solvents, shall not fit entirely within the small parts cylinder defined in 16 CFR part 1501 if it can be removed.
(d)Infant support surface firmness test method. Perform the following steps to determine the infant support surface firmness of the product as received from the manufacturer.
(1) Conduct tests at three locations on the surface to be tested, with 3 in. (7.62 cm) or more separation: maximum thickness perpendicular to the test surface and two other locations most likely to fail. When selecting these locations, the edge of the probe shall not extend beyond the edge of the product. If the design or size of the product is such that the edge of the probe must extend beyond the edge of the product, the probe shall be centered over as much of the test surface as possible.
(2) Lay the product, with the infant support surface facing up, on a test base that is horizontal, flat, firm, and smooth.
(3) Prevent movement of the product in a manner that does not affect the force or deflection measurement of the product surface under test. Provide no additional support beneath the product.
(4) Orient the axis of the 3-in. head probe (figure 1 to § 1242.4(a)) perpendicular to the test surface and aligned with a force gauge and parallel to a distance measurement device or gauge. Zero the force gauge.
(5) Using a lead screw or similar device to control movement along a single direction, advance the probe onto the product and set the deflection to 0.0 in. when a force of 0.1 N (0.02 lb) is reached.
(6) Continue to advance the head probe into the product at a rate not to exceed 0.1 inch per second and pause when the force exceeds 10.0 N (2.24 lb), or the deflection is equal to 1.00 in. (2.54 cm).
(7) Monitor the force and wait for it to stabilize, meaning the force has not changed more than 0.1 N (0.02 lb) for at least 30 s. If, after the force stabilizes, the deflection is less than 1.00 in. and the force is 10.0 N or less, repeat paragraphs (d)(6) and (7) of this section.
(8) Record the final force and deflection amounts.
(9) Repeat the infant support surface firmness tests on any other infant support surface and in all manufacturer-intended configurations that could affect the infant support surface, such as the folding or layering of parts of the product.
(e)Inner wall firmness test method. For nursing pillows with a caregiver opening, perform the steps in paragraphs (d)(1) through (8) of this section on the inner wall of the caregiver opening, and perform the following, to determine the inner wall firmness as received from the manufacturer. Repeat the inner wall firmness tests in all manufacturer-intended configurations that could affect the inner wall firmness.
(f)Product conditioning firmness test method. Following the firmness testing in paragraphs (d) and (e) of this section, perform the following steps to determine the product firmness after conditioning.
(1) Launder and dry the product according to the manufacturer's instructions.
(2) Repeat paragraph (d) of this section.
(3) Repeat paragraph (e) of this section.
(g)Infant containment test method.
(1) Lay the product, with the infant support surface facing up, on a test base that is horizontal, flat, firm, and smooth.
(2) For nursing pillows with a caregiver attachment, unsecure and move the caregiver attachment away from the caregiver opening.
(3) Place the 9-in. head probe (figure 2 to § 1242.4(b)) inside the caregiver opening such that the flat bottom of the probe rests on the test surface and the probe's perimeter contacts the innermost surface of the caregiver opening.
(4) If the inner wall of the caregiver opening contacts the outwardly facing portions of the probe, or the inner wall interferes with placing the probe down, the caregiver opening is considered to constrain the probe. See figure 2 to this paragraph (g)(4). Do not include in the assessment any contact with a caregiver attachment.

Figure 2 to Paragraph (g)(4)-Infant Containment, Example

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(5) With the probe at the position contacting the innermost surface within the caregiver opening, determine if any portion of the probe extends beyond a line projected across the outside limits of the caregiver opening.
(6) Slide the probe horizontally out of the caregiver opening to the outside of the nursing pillow. Determine if the probe is constrained by the inner wall of the caregiver opening contacting the outwardly facing portions of the probe. See figure 2 to paragraph (g)(4) of this section. Do not include in the assessment any contact with a caregiver attachment.
(7) For nursing pillows with a caregiver attachment, adjust and secure the caregiver attachment to the minimum length allowed by the product and repeat paragraphs (g)(3) through (g)(5).
(h)Seam strength test method.
(1) Equipment shall include clamps with 0.75 in. (1.9 cm) diameter clamping surfaces capable of holding fabric and with a means to attach a force gauge. Figure 3 to this paragraph (h)(1), or equivalent. The force gauge must have an accuracy of +/-0.5 lb (2.2 N).

Figure 3 to Paragraph (h)(1)-Seam Clamp

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(2) Clamp the fabric of the nursing pillow on each side of the seam under test with the 0.75 in. clamping surfaces placed not less than 0.5 in. (1.2 cm) from the seam.
(3) Apply a tension of 15 lb (67 N) evenly over 5 s. and maintain for an additional 10 s.
(4) Repeat the test on every distinct seam and every 6 in. (15 cm) along each seam.
(i)Caregiver attachment strength test method.
(1) Any suitable clamping devices with means to attach a force gauge with accuracy of 0.5 lb (1.2 N) may be used. The clamping surfaces shall grasp across the entire width of the strap or attachment element.
(2) Support the nursing pillow to resist the pull forces and release the buckle, clasp, or other fastener of the caregiver attachment.
(3) Clamp one side of the attachment or strap of the nursing pillow not less than 0.5 in. (1.2 cm) from the attachment to the nursing pillow.
(4) Apply a tension of 20 lb (89 N) evenly over 5 s. and maintain for an additional 10 s.
(5) Repeat the test on the other side of the attachment or strap.
(6) Join the buckle, clasp, or other fastener of the attachment or straps.
(7) Clamp both sides of the attachment or straps across the buckle, clasp, or other fastener, one on each side and not less than 0.5 in. (1.2 cm) from the fastener.
(8) Apply a tension of 20 lb (89 N) evenly over 5 s. and maintain for an additional 10 s.

16 C.F.R. §1242.5

89 FR 85414 , 4/23/2025