Certification and Registration
16 CFR Part 1235 – Infant Diaper Changing Standard
Category:
CPC
What are baby diaper‑changing products?
Under ASTM F2388‑21, “infant diapering products” include: (1) diaper changing tables; (2) changing table accessories; (3) additional changing devices; and (4) contoured changing pads.
Please note that only products defined as “infant diapering products” in ASTM F2388 are subject to this standard; for example, flat, non‑contoured changing mats typically included with diaper bags fall outside this definition and are therefore not covered by this standard.
●Diapering table – a raised, freestanding structure for changing infants ≤30 lb (13.6 kg), may convert to other furniture (e.g., dresser, desk), and may have pull‑out/drop‑down surfaces or storage.
● Diaper‑changing table accessory – attaches to a crib or play yard, with rigid frame and soft fabric/mesh surfaces.
● Additional diaper‑changing device – a rigid attachment for furniture or a standalone barrier to prevent rolling off.
● Contoured changing pad – foam pad with contoured edges and barriers, designed for use at height.
What is the purpose of the standard for infant diaper‑changing products?
This standard reduces injuries from normal use and reasonably foreseeable misuse, specifically from: (1) falls from tables; (2) structural/mechanical failures; (3) instability and entrapment in openings; and (4) suffocation.
Applicable Standards
16 CFR 1235 Safety Standard for Baby Changing Products
ASTM F2388-21 Standard Consumer Safety Specification for Baby Changing Products for Domestic Use
What are the specific requirements?
ASTM The standard’s general requirements for infant diaper-changing products include the following:
1. Sharp points and edges;
2. Small parts;
3. Surface coating;
4. Wooden components;
5. Open mouth;
6. Toys;
7. Threaded fasteners;
8. Protective components;
9. Cut, cut, and pinch;
10. Structural integrity;
11. Stability;
12. Obstacle;
13. A dressing pad with a defined contour and an additional dressing‑changing device are provided;
14. It is trapped on the shelf and in the enclosed opening;
15. Self-folding steps;
16. Restraint system;
17. Warnings and labels; and
18. Guiding literature.
Additional CPSIA requirements for infant diaper‑changing products
These products must comply with:
1.Surface coating – paint/finishes shall not exceed 90 ppm (0.009%) lead.
2.Lead content – any accessible part shall not exceed 100 ppm.
3.Phthalates – plasticised components shall not contain >0.1% of any of the eight restricted phthalates (DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, DCHP).
4.Testing and certification – must be tested by a CPSC‑accredited lab; based on results, the domestic manufacturer (or importer) must issue a Children’s Product Certificate (CPC).
5.Registration card – each product must include a postage‑paid registration form; manufacturers must maintain records and affix permanent markings with manufacturer name/contact, model/serial number, and manufacture date.
6.Tracking label – a permanent mark on product and packaging must include manufacturer/private‑label name, place and date of manufacture, and batch/lot number.
The U.S. market has strong demand for infant products, with equally stringent regulations. SATISFY offers compliance guidance for such products; contact SATISFY customer service for more details.
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