Background:

A study was done by an outside accredited lab to identify and measure the forces which will be presented to the product in order to allow prediction of the product performance as it relates to product integrity.

In order to identify an appropriate capability level for product design, the forces to which the product will be subjected to were identified and measured.

Samples of the product were tested for compliance with the following requirements associated with Simulated Use and Abuse Testing per the following:

16 CFR 1500.48 Sharp Point
16 CFR 1500.49 Sharp Edges
16 CFR 1501 Small Parts
16 CFR 1500.53(e) Mechanical Hazards: Simulated Use & Abuse Testing

Method:

Two devices were fabricated to collect the biomechanics data for this project. These devices consisted of a padded bite fixture on a force sensor and a simulated straw with a force gauge to measure and record the forces imparted to the product during biting and pulling.

• Child development experts have developed a protocol to ensure that experimental results are statistically significant. Variables such as environment, social factors, caregiver vigilance and age were taken into account. The capabilities of a statistically significant (thirty five) number of children between the ages of two and six years were measured.

• The Pull Strength and Bite Force Lower Spec Limits (LSL) was determined from this data to capture the 99 Percentile of children studied.

The measurements made in this study have also been used to develop a quality assurance methodology that can be used during the production of products to determine that critical design criteria are consistently adhered to during the manufacturing process.

View this short video illustrating testing results for the two primary categories, Simulated Use & Abuse Testing, referenced in part 16 CFR 1500 & 1501.