Federal Register - June 23, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Rules and Regulations
requirement. The requirement specifies that if a folding product does not have a latching or locking device, then it shall not fold when a 20-lb. force is applied in the direction most likely to fold the product with simulated infant occupant. The requirement also specifies if a folding product does have a single-action latch, then it shall not fold when a 10-lb. force is applied in the direction most likely to fold the product. Staff assesses that this requirement adequately simulates the action of unintentionally folding the product, and therefore, to address this risk of injury, we conclude that all flat sleep products with a lock or latch should at least meet the ASTM F2194
16e1 bassinets standards unintentional folding requirement.
The ASTM F219416e1 bassinets standard also includes a Removable Bassinet Bed Attachment to Base/
Stand performance requirement. A
removable bassinet bed attaches to the bassinet stand and is secured with a latch/lock. This requirement states a removable bassinet bed shall:
Not be supported by the bassinet stand in an unlocked/latched configuration;
automatically lock to the bassinet stand and cant be placed in an unlocked position on the bassinet stand;
clearly and obviously be unstable when the product is unlocked/latched by placing the sleeping surface at a 20-degree incline;
have a false latch/lock visual indicator designed to visually alert caregivers when the bed is not properly locked to the stand; or have a lock/latch mechanism that is not needed to pass the stability requirement.
The purpose of this requirement is to ensure that bassinets that can be removed from their stand are securely latched to the stand when in use. Staff assesses that the ASTM F219416e1
bassinets standards requirement adequately simulates the action of a
bassinet unintentionally unlatching from its stand. Staff also assesses that the ASTM F219416e1 bassinets standards requirement is more stringent compared to the ASTM F311817a infant inclined sleep products standard, which lacks a requirement for products that can be removed from a stand.
Therefore, the final rule requires that flat sleep products meet the ASTM
F219416e1 bassinets standards unintentional folding requirement and the Removable Bassinet Bed Attachment to Base/Stand requirement, if applicable, to address the risk of injury associated with locks and latching features on these products.
b Hazard: Falls/Containment Issue Twelve of the 183 incidents were related to falls or an infant otherwise not being kept contained within the product. Of the 12 incidents, one resulted in a death, one required hospital admission, and nine required ED visits. Failure to contain occupants in an infant sleep product can lead to infants falling or climbing out of the infant sleep product into a hazardous area.
Typically, regulated sleep products do not allow an active occupant restraint system for occupant containment.
Active restraint systems are only effective when the caregiver actively uses them and adjusts them correctly;
however, in a sleep environment, active restraints can create an entanglement and asphyxiation hazard.
The ASTM F219416e1 bassinets standard does not allow the use of restraints, and instead addresses containment-related hazards posed with a side height requirement, a passive safety feature. The requirement specifies that the products interior side height with an uncompressed mattress shall be at least 7.5 inches.
In 2012, the ASTM F219412
bassinets standard first required a minimum 7.5-inch side height based on the Canadian standard.36 The side height is measured from the upper surface of the uncompressed mattress to
the upper surface of the lowest side.
This requirement remains in effect in the most recent version of the bassinets standard, ASTM F219416e1. Canada requires a side height of 230 mm 9
inches, measured from the mattress support. Because ASTM F219416e1
allows a bassinet mattress of 1.5 inches, measuring from the upper surface of the mattress support, which is underneath the mattress, to the upper surface of the side would be 1.5 inches greater than measuring from the upper surface of an uncompressed mattress. Therefore, staff assesses that the 7.5-inch side height, from the upper surface of an uncompressed mattress is functionally equivalent to the 9-inch side height, measured from the upper surface of the mattress support in Canada.
Products that CPSC staff identified as flat sleep products are not currently subject to a voluntary or mandatory standard that specifies a minimum side height. Flat sleep products that are considered hand-held carriers under 16
CFR part 1225, Safety Standard for Hand-Held Infant Carriers, and ASTM
F205019, Standard Consumer Safety SpeciÉcation for Hand-Held Infant Carriers, can be defined as a hand-held bassinet/cradle product intended for sleep, but hand-held bassinet/cradles are not subject to a side height requirement in the mandatory or voluntary standard. Products without a minimum side height could fail to contain occupants, which can lead to infants falling or climbing out of the product into a hazardous area.
Table 4 shows the side height requirements for each sleep product standard. Sleep products that have a minimum side height requirement range from 2-inches for the voluntary standard for infant inclined sleep products, to 9inches for cribs. Bassinets, bedside sleepers, and infant inclined sleep products are intended for infants from birth to 5-months old. Cribs are intended for newborns up to children 35-inches tall, which is equivalent to a 95th percentile in stature 21-month-old.
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TABLE 4SIDE HEIGHT REQUIREMENTS FOR SLEEP PRODUCTS
Standard
Side height requirement
16 CFR 1218Safety Standard for Bassinets and Cradles
ASTM F219416e1, Standard Consumer Safety Specification for Bassinets and Cradles.
16 CFR 1219Safety Standard for Full-Size Baby Cribs
ASTM F116919, Standard Consumer Safety Specification for FullSize Baby Cribs.
7.5 inches
05 months, or sit up.
9 inches
035 inches tall 95th percentile 21-month old.
36 78
Age range
FR 63,109 Oct. 23, 2013.
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