This document specifies the particular requirements for the basic safety and essential performance of tapping-type dermal needles for single use. It applies to tapping-type dermal needles that have the capacity to penetrate the skin.

It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of tapping-type dermal needles.

It does not apply to roller-type dermal needles, reusable tapping-type dermal needles or devices incorporating a detachable tapping head.