BS EN ISO 19715:2017 pdf free download.Dentistry – Filling instrument with contra angle.
1 Scope
BS EN ISO 19715 specifies requirements and test methods for a filling instrument with contra angle, which is used for the restoration of teeth via the application of polymer-based restorative materials and cements. it also specifies requirements for the design, dimensions and marking.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of BS EN ISO 19715. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
Iso 1942 , Dentistry — Vocabulary
ISO 6507-1 , Metallic materials — Vickers hardness test — Part 1: Test method
ISO 6508-1 , Metallic materials — Rockwell hardness test — Part 1: Test method
Iso 17664 , Sterilization of medical devices — information to be provided by the manufacturer for the processing of resterilizable medical devices
4 Classification
Filling instruments with contra angles are classified into the following types according to the design of the working end:
— Type A: Ball corresponding to Eiiwv2
— Type B: Pear corresponding to Figure 3:
— Type C: Plane plugger corresponding to FigureA or Figure.5;
— Type I): Spatula, curved over edge corresponding to Figure 6:
— Type E: Spatula, curved over surface (beaver tail) corresponding to Figure 7.
Figure 8 — Dimensions for filling instruments with contra angle
5.2 Dimensions of working end
Working ends of filling instruments with contra angles shall satisfy the dinwnsions indicated in TableJ. and Tahle.2.
The diameter for Type A shall be: mm. 0,8 mm, max. 3,5 mm.
The diameter for Type B shall be: mm. 0,8 mm, max. 2,5 mm.
The diameter for Type C shall be: mm. 0,8 mm, max. 2,5 mm.
The diameter for Type D shall be: mm 1,0 mm, max. 3,2 mm.
The diameter for Type E shall be: mm. 1,0 mm, max. 3,2 mm.
The material of both the handle and the working tip is at the manufacturer’s discretion provided that the requirements of BS EN ISO 19715 are met. If stainless steel is the material of choice, examples of suitable steel types can be found in ISO 7153-1.
The stainless steel of the filling instrument shall have a hardness of 42 HRC to 60 HRC.
Test in accordance with 6.2.
5.4 Surface finish
The working ends of the filling instrument shall be polished with a surface roughness, Ra, not exceeding 0,4 lIm, except where otherwise designed. The surface can be gloss or matte, at the manufacturer’s discretion. All surfaces of the filling instrument shall be free of any surface defects and residues.
Coatings may be added to the working tip of metal filling instruments to increase lubricity and provide contrast in the oral cavity.
Test in accordance with 6.
5.5 Handle
The shape of the handle (e.g. circular, octagonal) is left to the discretion of the manufacturer.
5.6 Designation and combination of working ends
The designation and combination of the working ends is described in Annex A.
5.7 Resistance to reprocessing
The filling instrument shall withstand 100 reprocessing cycles, as defined by the manufacturer’s instructions, in accordance with ISO 17664 without visible signs of distortion, deterioration in performance, or signs of corrosion.
Non-metallic filling instruments shall withstand the same reprocessing materials as metallic filling instruments, unless:
Measure the dimensions using a device that is accurate to 1/10 of the tolerance to be measured.
NOTE Example of suitable measuring devices are vernier calipers and micrometers in accordance
with ISO 3611.
6.2 Hardness testing
Carry out hardness testing in accordance with ISO 6508-1 , scale C or ISO 6507-1.
6.3 Surface roughness inspection
Measure the surface roughness, R a by using a profilometer or calibrated reference plates by probing at the central point that is 1 mm in linear distance from the working end of the instrument.
6.4 Resistance to reprocessing test
Carry out 100 reprocessing cycles with the filling instrument, as defined by the manufacturer’s instructions, in accordance with ISO 17664.
lithe manufacturer has specified a maximum number of cycles less than 100, this number shall be used for the test.
Inspect the filling instrument for signs of deterioration, distortion or corrosion. NOTE Discolorations due to water stains are not signs of corrosion.
7 Marking
Filling instruments with contra angle shall be indelibly marked with the following information:
a) name of the manufacturer and/or trade name;
b) model number (reference number);
c) lot number (batch designation).