YY 0302.1: Evolution and historical versions
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Dental rotary instruments. Burs. Part 1: Steel and carbide burs
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Basic data | Standard ID | YY 0302.1-2010 (YY0302.1-2010) | | Description (Translated English) | Dental rotary instruments. Burs. Part 1: Steel and carbide burs | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 28,234 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Older Standard (superseded by this standard) | YY 0302-1998 | | Quoted Standard | GB/T 6682-2008; ISO 1797-1-1992; ISO 2157-1992; ISO 6360-1-2004; ISO 6360-2-2004; ISO 8325-2004 | | Adopted Standard | ISO 3823-1-1997, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the shape of the ten most commonly used steel and carbide bur size and requirements, including the quality control requirements of these devices. | YY 0302.1-2010: Dental rotary instruments. Burs. Part 1: Steel and carbide burs---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Dental rotary instruments.Burs.Part 1. Steel and carbide burs
ICS 11.060.20
C33
People's Republic of China pharmaceutical industry standards
Replacing YY 0302-1998
Dental rotary instruments bur
Part 1. Steel and carbide burs
Part 1. Steelandcarbideburs
(ISO 3823-1.1997, MOD)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Category 1
4 Size symbol 1
5 requires 1
6 Test methods 17
7 23 Quality Control
8 marks 23
9 Packaging 23
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.
The main drafters of this section. Peng Canguang, Lei Xiufeng, Li Danrong.
This section was first released in 1989, the first revision in 1998, this is the second revision.
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.
It should be noted, ISO 6360 standard which gives a 15-bit digital coding system used to classify all types of dental rotary
instrument.
Dental rotary instruments bur
Part 1. Steel and carbide burs
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.
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