Tiêu chuẩn iso 03823 2 2003

Microsoft Word C030891e doc Reference number ISO 3823 2 2003(E) © ISO 2003 INTERNATIONAL STANDARD ISO 3823 2 Second edition 2003 05 15 Dentistry — Rotary bur instruments — Part 2 Finishing burs Art de[.]

Material

Steel finishing burs must be constructed from high-quality steel, while carbide finishing burs should be made of tungsten carbide, ensuring durability and precision The choice of material and its treatment is at the manufacturer's discretion, allowing for optimal performance based on specific application requirements Proper material selection is crucial for achieving effective and long-lasting finishing results in dental and industrial applications.

The material of the shank shall comply with ISO 1797-1.

Shape

The shape of the working part must adhere to the specifications outlined in Figures 1 to 34, with permitted variations within defined dimensions Minor shape variations are allowed as long as they comply with the terms specified in the respective subclause titles, ensuring consistency and conformity to design standards.

Testing shall be carried out in accordance with 6.1.

Dimensions and number of blades

5.3.1 Units used for dimensions and angles

Dimensions are given in millimetres, angles are given in degrees

The dimensions of the working part shall be as specified in Tables 1 to 34

The number of blades shall be as specified in Tables 1 to 34 The numbers refer to instruments with medium (standard) fineness

The toothing illustrated in Figures 1 to 34 are provided as examples only; the final toothing design shall be determined at the manufacturer's discretion Toothing identification must comply with the standards outlined in ISO 6360-3, ensuring consistency and proper classification across applications.

Testing shall be carried out in accordance with 6.2

The shank shall be Type 1, 2 or 3 in accordance with ISO 1797-1

The overall length of the instrument, l 2 , depends on the fitting length of the shank used

In the provided tables (Tables 1 to 34), the term “Standard” denotes instruments featuring standard fitting lengths of their shanks When instruments have longer or shorter shank lengths, their overall length (l2) adjusts accordingly to accommodate these variations For precise fitting length specifications of the shanks, reference should be made to ISO 1797-1:1992, Table 1, ensuring compliance with standardized dimensions in dental instrument design.

Testing shall be carried out in accordance with 6.2

5.3.5 Figures and Tables for steel finishing burs

Figure 1 — Spherical, steel finishing burs

Table 1 — Spherical, steel finishing burs: Dimensions and number of blades

Designation of nominal diameter d 1 d 2 l 1 Number of blades l 2 ± 0,5

(Nominal size) nom tol max min min

Copyright International Organization for Standardization

Figure 2 — Bud, steel finishing burs

Table 2 — Bud, steel finishing burs: Dimensions and number of blades

Taper angle of the head < 2°

Figure 3 — Cylindrical, steel finishing burs

Table 3 — Cylindrical, steel finishing burs: Dimensions and number of blades

Figure 4 — Flame, steel finishing burs

Table 4 — Flame, steel finishing burs: Dimensions and number of blades

Figure 5 — Egg, steel finishing burs

Table 5 — Egg, steel finishing burs: Dimensions and number of blades

Figure 6 — Conical, steel finishing burs

Table 6 — Conical, steel finishing burs: Dimensions and number of blades

Figure 7 — Interproximal, steel finishing burs

Table 7 — Interproximal, steel finishing burs: Dimensions and number of blades

5.3.6 Figures and Tables for carbide finishing burs

Figure 8 — Spherical, carbide finishing burs

Table 8 — Spherical, carbide finishing burs: Dimensions and number of blades

Figure 9 — Bud, carbide finishing burs

Table 9 — Bud, carbide finishing burs: Dimensions and number of blades

Taper angle of the head < 2°

Figure 10 — Cylindrical, carbide finishing burs

Table 10 — Cylindrical, carbide finishing burs: Dimensions and number of blades

Figure 11 — Flame, short, carbide finishing burs

Table 11 — Flame, short, carbide finishing burs: Dimensions and number of blades

Figure 12 — Flame, long, carbide finishing burs

Table 12 — Flame, long, carbide finishing burs: Dimensions and number of blades

Figure 13 — Egg, carbide finishing burs

Table 13 — Egg, carbide finishing burs: Dimensions and number of blades

5.3.6.6.1 Conical, sharp edge, regular α = 4° to 8°

Figure 14 — Conical, sharp edge, regular, carbide finishing burs

Table 14 — Conical, sharp edge, regular, carbide finishing burs: Dimensions and number of blades

5.3.6.6.2 Conical, sharp edge, head length above 6,5 mm α = 4° to 8°

Figure 15 — Conical, sharp edge, head length above 6,5 mm, carbide finishing burs

Table 15 — Conical, sharp edge, head length above 6,5 mm, carbide finishing burs:

5.3.6.7.1 Conical, rounded edge, regular α = 4° to 8°

Figure 16 — Conical, rounded edge, regular, carbide finishing burs

Table 16 — Conical, rounded edge, regular, carbide finishing burs: Dimensions and number of blades

5.3.6.7.2 Conical, rounded edge, head length above 7,5 mm α = 4° to 8°

Figure 17 — Conical, rounded edge, head length above 7,5 mm, carbide finishing burs

Table 17 — Conical, rounded edge, head length above 7,5 mm, carbide finishing burs:

Figure 18 — Pear, short, carbide finishing burs

Table 18 — Pear, short, carbide finishing burs: Dimensions and number of blades

Figure 19 — Pear, long, carbide finishing burs

Table 19 — Pear, long, carbide finishing burs: Dimensions and number of blades

Figure 20 — Interproximal, carbide finishing burs

Table 20 — Interproximal, carbide finishing burs: Dimensions and number of blades

Designa- tion of nominal diameter d 1 d 2 d 3 l 1 Number of blades l 2 ± 0,5

(Nominal size) nom tol max max min min

Figure 21 — Bullet, carbide finishing burs

Table 21 — Bullet, carbide finishing burs: Dimensions and number of blades

5.3.6.11.1 Torpedo, cylindrical, head length 5 mm

Figure 22 — Torpedo, cylindrical, head length 5 mm, carbide finishing burs

Table 22 — Torpedo, cylindrical, head length 5 mm, carbide finishing burs:

Table 25 — Torpedo, cylindrical, head length 10 mm, carbide finishing burs: Dimensions and number of blades

5.3.6.12.1 Torpedo, conical, head length 5 mm α = 4° to 8°

Figure 26 — Torpedo, conical, head length 5 mm, carbide finishing burs

Table 26 — Torpedo, conical, head length 5 mm, carbide finishing burs: Dimensions and number of blades

Table 27 — Torpedo, conical, head length 6 mm, carbide finishing burs: Dimensions and number of blades

Table 28 — Torpedo, conical, head length 8 mm, carbide finishing burs:

Table 29 — Torpedo, conical, head length 10 mm, carbide finishing burs:

5.3.6.13.1 Cylindrical, rounded edge, head length 6 mm

Figure 30 — Cylindrical, rounded edge, head length 6 mm, carbide finishing burs

Table 30 — Cylindrical, rounded edge, head length 6 mm, carbide finishing burs:

5.3.6.13.2 Cylindrical, rounded edge, head length 8 mm

Figure 31 — Cylindrical, rounded edge, head length 8 mm, carbide finishing burs

Figure 32 — Cylindrical, end hemispherical, carbide finishing burs

Table 32 — Cylindrical, end hemispherical, carbide finishing burs: Dimensions and number of blades

Figure 33 — Inverted conical, carbide finishing burs

Table 33 — Inverted conical, carbide finishing burs: Dimensions and number of blades

Figure 34 — Conical, rounded edge, carbide finishing burs

Table 34 — Conical, rounded edge, carbide finishing burs: Dimensions and number of blades

Run-out

The total indicated run-out shall not exceed the following values:

For steel finishing burs: 0,08 mm

For carbide finishing burs: 0,05 mm

Testing shall be carried out in accordance with 6.3.

Cleaning, disinfection and sterilization

The manufacturer of the instrument shall provide instructions for cleaning and disinfection

Steel and carbide finishing burs shall show no visible signs of corrosion or deterioration when processed according to these instructions

The manufacturer of the instrument shall provide instructions for sterilization

Carbide steel finishing burs shall show no visible signs of corrosion or deterioration when tested according to ISO 13402:1995, Clause 3, the test pieces having been subjected to three test cycles.

Neck strength

The instrument shall not fracture or take a permanent set exceeding:

For steel finishing burs: 0,08 mm

For carbide finishing burs: 0,05 mm

Testing shall be carried out after the corrosion test and in accordance with 6.5

Shape

Determine the shape by using a shadowgraph or measuring the relevant dimensions in accordance with ISO 8325:1985, 3.1 to 3.5, as appropriate.

Measure the dimensions in accordance with ISO 8325:1985, 3.1 to 3.5, as appropriate

Determine the number of blades by visual inspection.

Run-out

Determine the run-out in accordance with ISO 8325:1985, 3.6

The measurement point shall be the largest diameter or the middle of the working part for cylindrical instruments

Corrosion resistance (in accordance with ISO 13402)

Autoclave, operating in the non-vacuum mode, capable of being operated at a temperature of 134 °C to

138 °C and at a pressure of 0,22 MN⋅m –2 (2,2 bar)

Distilled or deionized water, Quality 3 in accordance with ISO 3696

6.4.3 Preparation of the test piece

Scrub the test piece with a copper bur brush for 10 s using soap and warm water Rinse thoroughly in water (6.4.2) and dry

Insert the unwrapped test specimen into the autoclave and perform a single sterilization cycle at 134°C to 138°C for 3 minutes plus an additional 0.5 minute, using water as specified in section 6.4.2, under a pressure of 0.22 MN⋅m–2 After the cycle, carefully open the autoclave door and remove the test piece, then allow it to cool to room temperature before further analysis.

Visually inspect the test piece at normal visual acuity for any signs of corrosion

Determine the neck strength in accordance with ISO 8325:1985, 3.7 and report on any deterioration or failure.

Neck strength

Determine the neck strength in accordance with ISO 8325:1985, 3.7 and after the test for corrosion resistance, if applicable

For testing loads (F), use the specified values provided in Tables 35 to 68, which cover different sizes of finishing burs as outlined in ISO 3823 For burs not listed, the appropriate test load F can be calculated using the data and the formula provided in ISO 8325:1985.

6.5.2 Test loads F for steel finishing burs

Table 35 — Spherical, steel finishing burs: Test loads

Table 36 — Bud, steel finishing burs: Test loads

Table 37 — Cylindrical, steel finishing burs: Test loads

Table 38 — Flame, steel finishing burs: Test loads

Table 39 — Egg, steel finishing burs: Test loads

Table 40 — Conical, steel finishing burs: Test loads

Table 41 — Interproximal, steel finishing burs: Test loads

6.5.3 Test loads F for carbide finishing burs

Table 42 — Spherical, carbide finishing burs: Test loads

Table 43 — Bud, carbide finishing burs: Test loads

Table 44 — Cylindrical, carbide finishing burs: Test loads

Table 45 — Flame, short, carbide finishing burs: Test loads

Table 46 — Flame, long, carbide finishing burs: Test loads

Table 47 — Egg, carbide finishing burs: Test loads

Table 48 — Conical, sharp edge, regular, carbide finishing burs: Test loads

Table 49 — Conical, sharp edge, head length above 6,5 mm, carbide finishing burs:

Table 50 — Conical, rounded edge, regular, carbide finishing burs: Test loads

Table 51 — Conical, rounded edge, head length above 7,5 mm, carbide finishing burs:

Table 52 — Pear, short, carbide finishing burs: Test loads

Table 53 — Pear, long, carbide finishing burs: Test loads

Table 54 — Interproximal, carbide finishing burs: Test loads

Table 55 — Bullet shape, carbide finishing burs: Test loads

Table 56 — Torpedo, cylindrical, head length 5 mm, carbide finishing burs: Test loads

Table 60 — Torpedo, conical, head length 5 mm, carbide finishing burs: Test loads

Table 66 — Cylindrical, hemispherical, carbide finishing burs: Test loads

Table 67 — Inverted conical, carbide finishing burs: Test loads

Table 68 — Conical, rounded edge, carbide finishing burs: Test loads

Sampling

For quality assessment, select a sample of 100 to 150 finishing burs, ensuring inclusion of at least 20 burs for each of five distinct sizes and all three types of shank Each sample must be checked for specific defects outlined in section 7.2, with 20 burs examined for each defect The batch is deemed acceptable if no more than three burs are rejected within each defect category; however, if four or more burs fail any defect criteria, the entire batch does not meet the specified quality standards.

The acceptance quality limit, expressed as the maximum acceptable number of defects per 100 pieces, shall be 6,5 max

The identified defects include total indicated run-out exceeding specified limits, head diameter not meeting the specified dimensions, neck diameter surpassing the maximum allowed value, neck or joint breakage or permanent set occurring under lower-than-specified loads, head length falling below the minimum required, and overall length not conforming to the specified measurements.

Packaging labels for finishing burs must include essential information such as the manufacturer’s name or trade mark, material of the working part, and the type of shank according to ISO 1797-1 standards They should also specify the shape number, specific characteristics, and indicate if the instrument is sterile using a designated word or symbol Additionally, the label must display the nominal diameter and size, along with the lot number for traceability, ensuring compliance with labeling regulations and aiding user safety.

The information shall be given in accordance with ISO 6360-1

Steel and carbide finishing burs shall be packaged at the discretion of the manufacturer

[1] ISO 2157, Dental rotary instruments — Nominal diameters and designation code number

Tiêu đề	Dentistry — Rotary Bur Instruments — Part 2: Finishing Burs
Trường học	International Organization for Standardization
Chuyên ngành	Dentistry
Thể loại	international standard
Năm xuất bản	2003
Thành phố	Geneva

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