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It applies to writing instruments “which in normal or foreseeable circumstances are likely to be used by children up to the age of 14 years.” Fancy fountain pens and other writing instruments that are clearly designed for adult use don’t need to have holes in them, nor do caps that are large enough that you can’t swallow them. Any pen that could conceivably make its way into the hands of a child needs to have an air hole in the cap that provides a minimum flow of 8 liters (about 2 gallons) of air per minute, according to the standard [PDF].
Pen cap inhalation is a real danger, albeit a rare one, especially for primary school kids. A 2012 study [PDF] reported that pen caps account for somewhere between 3 and 8 percent of “foreign body aspiration,” the official term for inhaling something you’re not supposed to. Another study found that of 1280 kids (ages 6 to 14) treated between 1997 and 2007 for foreign body inhalation in Beijing, 34 had inhaled pen caps.
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