Evaluation of the standardization of injection dental needles marketed in Brazil

Abstract

The standardization of sterile, single-use dental injection needles marketed in Brazil in 1997 was evaluated. The effective needle length (L1), butt end length (L2), socket depth (L3), external (ED) and internal (ID) diameters, corrosion resistance of the cannula, and the information printed on the package (unitary protector and box) were evaluated. The data were compared with the International Standard (ISO), American specification no. 54 (ANSI/ADA) and French Standard (FS). There were great variations for L1, L2, L3 and ID, and no trade mark fitted in any of the standards for all the dimensions. The external diameter showed very little variation in all the trade marks according to the ANSI/ADA and FS. All of the needles withstood the corrosion test. Some trade marks had incomplete information in their package and one of them had no expiration date. Some of the unitary protectors, once opened, did not show clear evidence of having been violated. These results show the need for a Brazilian specification to regulate the manufacturing of single-use dental injection needles.