YY 0302.1-2010Dental rotary instruments—Burs - Part 1: Steel and carbide burs (English PDF)
牙科旋转器械 车针 第1部分:钢质和硬质合金车针
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY 0302.1-2010 is the English-translated version of 牙科旋转器械 车针 第1部分:钢质和硬质合金车针.
YY 0302.1-2010 is the Chinese pharmaceutical industry standard for the steel and carbide burs used with dental rotary instruments.
It is the first part of the YY 0302 series and fixes the dimensions of the ten most common shapes of bur together with the requirements that go with them, and it sets the quality control required for these instruments, covering the head and the shank, the concentricity and the run-out, the cutting edges, the material and the corrosion resistance, and the marking of the size. Issued on 27 December 2010, it applies from 1 June 2012.
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Document preview — YY 0302.1-2010
National Standard of the People's Republic of China
- ICS
- 11.060.20
- Classification
- C 33
- Replacing
- YY 0302-1998
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Category
- 4 Size symbol
- 5 requires
- 6 Test methods
- 7 23 Quality Control
- 8 marks
- 9 Packaging
Foreword
YY 0302 divided into two parts.
--- Part 1. Steel and carbide burs;
--- Part 2. polished steel and carbide burs. This is Part 1 YY 0302 of.
The partial modification of the use of ISO 3823-1:1997 "bur dental rotary instruments - Part 1. Steel and carbide burs" (English Version). The main modifications are as follows.
--- For international standards cited in this section, if it has converted to our standards, international standards in this section will replace the corresponding reference number Number of national or industry standards, and in Chapter 2 marked on relationships.
--- Other international standards if references have been updated version of this section to replace the old version with a new version, the old version of the terms of reference in the text No. correspondingly modified to the new version of the corresponding article number.
This Part replaces YY 0302-1998 "high-speed dental bur." This part of the jurisdiction of the National Dental Materials and Devices Equipment Standardization Technical Committee dental equipment and instruments at the Technical Committee.
This section drafted by the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center.
Introduction
This section is a study on dental rotary instruments standards.
ISO 3823-1 second edition includes the modifications to the carbide bur requirements. About steel bur requirements remain unchanged.
This Part of the steel and tungsten carbide bur bur in size and other requirements are considered to ensure that the bur Interchangeability and safety in the dental clinic is very important.
Tables 1 to 22 are listed in the working portion of the nominal diameter consistent with the diameter specified in ISO 2157. The first column gives the diameter (Preferred diameter) should be used in preference.
1 Scope
This section specifies the YY 0302 ten most common shape steel and carbide bur size and requirements, including for Quality control requirements of these devices.
2 Normative references
The following documents contain provisions which, through reference YY 0302 present, constitute provisions of this section. For dated references, All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
GB/T 6682-2008 analytical laboratory use specifications and test methods (ISO 3696. 1987, MOD)
ISO 1797-1:1992 Dental rotary instruments - Part 1 lever. metal rod
ISO 2157:1992 Dental rotary instruments nominal diameter and design code number Section 2004 Dental rotary instruments - Number coding system for the first 1.. ISO 6360-1 general performance
ISO 6360-2:2004 Dental rotary instruments - Number coding system - Part 2. Shape and special performance
ISO 8325:2004 Dental rotary instruments - Test Method Category 3 Depending on the material of the working part, steel and carbide burs divided into the following two types.
--- Type 1. steel bur;
--- Type 2. Carbide bur.
4 Dimension symbol
This section uses the following symbols. d1 working part diameter, head diameter; d2 neck diameter; l1 working part length, head length; The total length l2.
5 Requirements
5.1 Material
5.1.1 Working part
Working part shall be made of steel or carbide. Select the type of material and processing method is determined by the manufacturer.
5.1.2 Lever
Rod material shall conform to the requirements of ISO 1797-1.
5.2 Shape
The shape of the working part of the provisions should be 1 ~ Fig. 22 some suitable shape.
In the size range within a predetermined range, and the corresponding entry in a predetermined shape changes and modifications are allowed.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 1797-1:1992 · ISO 2157:1992 · ISO 6360-2:2004 · ISO 8325:2004
Similar standards
Editions of YY 0302.1
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0302.1-2010 | Dental rotary instruments—Burs - Part 1: Steel and carbide burs | current edition | Current |
| YY 0302-1998 | Dental rotary instruments—Burs - Part 1: Steel and carbide burs | previous edition | Superseded |
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