YY 91064-1999Dental rotary instruments specification for steel and carbide bur (English PDF)
牙科放置器械 钢和硬质合金牙钻技术条件
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
January 26, 1985
Implementation date
May 1, 1985
Scope
YY 91064-1999 is the English-translated version of 牙科放置器械 钢和硬质合金牙钻技术条件.
YY 91064-1999, formerly ZB C 33001-84, is the Chinese pharmaceutical industry standard for steel and carbide dental burs used in the treatment room. It divides burs into Type I, steel, made of alloy tool steel, and Type II, carbide, with a carbide tip on an alloy or stainless steel shank or made entirely of carbide.
It sets the technical requirements: shank dimensions to GB 5046.1, tip diameters and designations to GB 5046.2, hardness, neck strength measured with the bur held at 22°30' from the vertical, and freedom from rust for a year and a half in storage, followed by the test methods, inspection rules, marking, packaging, transport and storage.
Finishing burs, laboratory burs and diamond burs are outside its scope. Issued on 26 January 1985, it has applied since 1 May 1985.
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Document preview — YY 91064-1999
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- 1 Dental bur type3
- 2 Dental bur materials3
- 3 Technical requirements3
- 4 Test method6
- 5 Inspection rules11
- 6 Marking, packaging, transportation, storage12
1 Dental bur type
Dental bur is divided into the following two types in accordance with the materials used at its tip. Type I - Steel dental bur; Type II - Carbide dental bur.
2 Dental bur materials
2.1 The steel dental bur shall be made of the alloy tool steel as specified in GB 1299-77 "Alloy tool steel - Technical conditions".
2.2 Carbide dental bur shall be made of the following materials.
2.2.1 The tip is made of hard alloy in YB 849-75 "Carbide designation", AND the stem is made of the alloy tool steel or stainless steel.
2.2.2 Both the tip and the stem are made of carbide in YB 849-75.
3 Technical requirements
3.1 Dental bur shall comply with the requirements of this standard AND shall be manufactured in accordance with the drawings and documents approved by the prescribed procedures.
3.2 The dimensions of the dental bur stem shall comply with the requirements of GB 5046.1-85 "Dental rotary instruments - Fit dimension".
3.3 The basic dimensions and designations of the tip diameter of the dental bur shall comply with the requirements of GB 5046.2-85 "Dental rotary instruments - Basic dimensions and designations".
3.8 The dental bur shall, after packaging, be guaranteed free of rusting within one and half a year under the storage conditions as specified.
3.4 Hardness
3.5 Neck strength
3.5.1 After the dental bur is subjected to neck strength test, it shall not break OR its permanent deformation shall not exceed the following values.
4 Test method
4.1 Hardness
4.1.1 Three points are taken from the tip of the steel dental bur AND the arithmetic mean of the three points is taken, which shall comply with the requirements of 3.4.1.
4.2 Neck strength
4.2.1 CLAMP the stem of the dental bur into the chuck tightly; MAKE it supported at the joint between its stem and neck; LET the dental bur axis form an angle of 22°30' with the vertical line. As shown in Figure 1, APPLY the load F1 as specified in clause 3.5.2; AND after the test for 5s, it shall comply with the requirements of clause 3.5.
4.4.2 Side edge cutting test
4.4.2.1 Test instruments
Instrument is the vertical movement slide carriage type, AND the fit part is the rolling ball type, as shown in Figure 5.
5 Inspection rules
5.1 Dental bur shall be inspected by the technical inspection departments of the manufacturer, AND it can only be delivered after passing the inspection.
5.3 During acceptance, FOLLOW the provisions of Table 12 to make, inspection one item by another.
5.4 In accordance with the inspection items and inspection range as specified in clause 5.3, in the acceptance process, if it finds one piece's performance fails to comply with the requirements of this standard, this batch of products shall all be returned for re-classification and resorting; if it finds one piece's size fails to comply with the requirements of this standard, it shall double the samples to make reinspection for the disqualified items; if it still fails to comply with the requirements of this standard, this batch of products shall all be returned back for re-classification and resorting.
6 Marking, packaging, transportation, storage
6.1 CONTAIN every 10 dental burs of the same type and specification into a box, AND the box shall have the following markings.
6.2 CONTAIN every 10 boxes or 100 boxes of the dental burs of the same type and specification into a carton, in which there shall be a test certificate.
6.3 The special packaging quantity and form shall follow the provisions of the order contract.
6.4 Packaging and transportation shall follow the provisions of the order contract.
6.5 The dental bur shall, after packaging, be stored in a well ventilated warehouse having a relative humidity of not more than 80% AND free from corrosive gases. […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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