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Bassinice (Problems to Tackle (Bed Height Adjustment, Bed Torso Adjustment…

- - - - "Eliminates hardware accessible to a child within the crib" "Standard Consumer Safety Specification for Full-Size Baby Cribs"
        ASTM International Standard F1169-13 section 5.10
        -pg 60813 Sharon's "Read This" FDA Doc
      - "Distance between side rail components...shall not exceed 2-3/8" (6cm)" "Standard Consumer Safety Specification for Full-Size Baby Cribs"
        ASTM International Standard F1169-13 section 5.7.2 and 5.8.1
        -pg 60813 Sharon's "Read This" FDA Doc
      - "no gap shall exist between the edge of the bottom rail and the top of the mattress surface" "Standard Consumer Safety Specification for Full-Size Baby Cribs"
        ASTM International Standard F1169-13 section 5.9
        -pg 60813 Sharon's "Read This" FDA Doc
      - "the mattreess must fit tightly around all four sides of the crib" "Standard Consumer Safety Specification for Full-Size Baby Cribs"
        ASTM International Standard F1169-13 section 5.9
        -pg 60813 Sharon's "Read This" FDA Doc
      - "Adequate instructions for users to care for an maintain their crib"
        -pg 60813 Sharon's "Read This" FDA Doc
  - - - Medical Bassinet
        
        Required Label (affixed to front of base cabinet >10mm tall)
        "WARNING: To avoid tipping hazards of this device, make sure that the basket or bed component sits firmly in the base and that all doors, drawers, and casters are secure."
        -pg 60814 Sharon's "Read This" FDA Doc
        
        "Material compatibility with cleansing products labeled to clean the device"
        -pg 60814 Sharon's "Read This" FDA Doc
        
        (1) The manufacturer must conduct performance testing to determine material compatibility with cleansing products labeled to clean the device. Testing must demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device;
        
        (2) Manufacturers shall conduct performance testing to ensure the mechanical and structural stability of the bassinet under expected conditions of use, including transport of patients in the bassinet. Testing must demonstrate that failures such as wheel or caster breakage do not occur and that the device does not present a tipping hazard due to any mechanical failures under expected conditions of use; and
        
        (3) Each device must have the following label(s) affixed:
        
        (i) Adequate instructions for users to care for, maintain, and clean the bassinet; and
        
        (ii) A warning label on at least two sides of the plastic basket or bed component with the following language in text of at least 9 millimeters in height: WARNING: To avoid tipping hazards of this device, make sure that the basket or bed component sits firmly in the base and that all doors, drawers, and casters are secure.
      - Pediatric Medical Cribs
        www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30193.pdf#page=7
        
        (3) The height of the rail and end panel as measured from the top of the rail or panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches (66 centimeters). Any mattress used in this crib must not exceed a thickness of 6 inches;
        
        (1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged;
        
        (2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation, and be free from surface defects that could result in injuries;
        
        (4) Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient;
        
        (5) The distance between components of the side rail
        (i.e., slats, spindles, and corner posts) shall not be greater than 23⁄8 inches (6 centimeters) apart at any point;
        
        (6) The mattress must fit tightly around all four sides of the crib base, such that entrapment or impingement of occupant is prevented;
        
        (7) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the flammability of mattresses and mattress pads (FF 4–72, amended) and Standard for the flammability (open flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and
        
        (8) Each device must have the following label(s) affixed:
        
        (i) Adequate instructions for users to care for, maintain, and clean the crib; and
        
        (ii) A warning label on at least two sides of the medical crib with the following language in text of at least 9 millimeters in height: WARNING: Never leave a child unsupervised when the
    - - Pediatric Medical Cribs
        see www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30193.pdf#page=7
        "Cribs intended for medical purposes (product code FMS)"
        "intended for use in the cure, mitigation or treatment of disease"
        -pg 60810 Sharon's "Read This" FDA Doc
        "Pediatric Hospital Bed" regulation changing to "Pediatric Medical Crib" and place medical bassinets in a separate class.
        -pg 60814 Sharon's "Read This" FDA Doc
        "Pediatric medical cribs used in health care settings contain a drop-side rail design that includes movable and latchable side and end rails."
        -pg 60814 Sharon's "Read This" FDA Doc
      - Medical Bassinet
        see www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30193.pdf#page=7
        (1) A basket, the sleep or bed component, which is typically made of plastic and
        (2) a durable frame with wheels, which holds the basket or bed component
        The basket specifically has open top and four stationary walls
        -pg 60810 Sharon's "Read This" FDA Doc
        A medical bassinet is a prescription device that is a small bed intended for use with pediatric patients, generally from birth to approximately 5 months of age. It is intended for medical purposes for use in a nursery, labor and delivery unit, or patient room, but may also be used outside of traditional health care settings. A medical bassinet is a nonpowered device that consists of two components: The plastic basket or bed component and a durable frame with wheels, which holds the basket or bed component. The basket or bed component is a box-like structure, generally made of a clear, high impact resistant plastic material, with an open top and four stationary walls to hold the pediatric patient. The frame can include drawers, shelving, or cabinetry that provides space to hold infant care items. The wheels or casters allow the bassinet to transport the infant throughout the care setting
        -www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30193.pdf#page=7
      - Pediatric Hospital Bed (older Regulations)
        "A device intended for medical purposes that consists of a bed or crib designed for the use of a pediatric patient, with fixed end rails and movable latchable side rails. The contour of the bed surface bay be adjustable"
        -pg 60810 Sharon's "Read This" FDA Doc
        "classified as class II, 510(k) exempt medical devices intended for the treatment, care, or diagnosis of diseases or illnesses of pediatric patients."
        -pg 60814 Sharon's "Read This" FDA Doc
        "A pediatric hospital bed is a device intended for medical purposes that consists of a bed or crib designed for the use of a pediatric patient, with fixed end rails and movable and latchable side rails. The contour of the bed surface may be adjustable."
        -www.law.cornell.edu/cfr/text/21/880.5140
  - - - "the mattress...shall meet the Flammability of Mattresses and Mattress Pads and its Standard for the Flammability of Mattress Sets"
        16 CFR parts 1632 and 1633
        -pg 60813 Sharon's "Read This" FDA Doc