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YY/T 0302.2-2016 English PDF

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YY/T 0302.2-2016: Dentistry-Rotary bur instruments--Part 2: Finishing burs
Status: Valid

YY/T 0302.2: Evolution and historical versions

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YY/T 0302.2-2016English819 Add to Cart 6 days [Need to translate] Dentistry-Rotary bur instruments--Part 2: Finishing burs Valid YY/T 0302.2-2016
YY/T 0302.2-2016English819 Add to Cart 6 days [Need to translate] Dentistry-Rotary bur instruments--Part 2: Finishing burs Valid YY/T 0302.2-2016

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Basic data

Standard ID YY/T 0302.2-2016 (YY/T0302.2-2016)
Description (Translated English) Dentistry-Rotary bur instruments--Part 2: Finishing burs
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.20
Word Count Estimation 37,338
Date of Issue 2016-03-23
Date of Implementation 2018-01-01
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to dressing burs made of steel or hard alloy. This standard specifies the dimensions and related requirements for the 17 most commonly used shapes of steel and carbide dressing burs, including quality control requirements and marking requirements for these instruments.

YY/T 0302.2-2016: Dentistry-Rotary bur instruments--Part 2: Finishing burs

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ICS 11:060:20 C33 Pharmaceutical Industry Standard of the People's Republic of China YY 0302:2-2016 Dental rotary instrument bur Part 2: Repairing burs (ISO 3823-2:2003, MOD) According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: 2016-03-23 release:2018-01-01 implementation Issued by China Food and Drug Administration

table of contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Category 1 4 symbols 1 5 requirements 1 6 Test method 23 7 Quality Control 30 8 mark 31 9 packs of 31 Reference 32 YY 0302:2-2016

foreword

YY 0302 consists of the following 2 parts: ---YY 0302:1 Dental rotary instrument burs Part 1: Steel and carbide burs; ---YY 0302:2 Dental rotary instrument burs Part 2: Dressing burs: This part is the second part of YY 0302: This section is drafted in accordance with the rules given in GB/T 1:1-2009: This part adopts redrafting method to revise and adopt ISO 3823-2:2003 "Dental rotary bur instruments Part 2: Dental burs for dressing" and its modification 1:2008: The main revisions are as follows: Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country, and the adjustments are concentrated Reflected in Chapter 2 "Normative References", the specific adjustments are as follows: GB/T 6682-2008 Analytical Laboratory Water Specifications and Test Methods (ISO 3696:1987, MOD) YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical devices (ISO 13402:1995, MOD) YY 0967:1-2015 Dental Rotary Instrument Rods Part 1: Metal Rods (ISO 1797-1:1992, MOD) YY/T 0873:1-2013 Digital coding system for dental rotary instruments Part 1: General characteristics (ISO 6360-1:2004, IDT) YY/T 0873:3-2014 Digital coding system for dental rotary instruments Part 3: Characteristics of burs and knives (ISO 6360-3: 2005, IDT) YY/T 0874-2013 Test method for dental rotating instruments (ISO 8325:2004, IDT) Please note that some contents of this document may refer to patents: The issuer of this document assumes no responsibility for identifying these patents: This part is proposed by China Food and Drug Administration: This part is prepared by the Dental Equipment and Instruments Sub-Technical Committee of the National Dental Materials and Equipment Standardization Technical Committee (SAC/TC99 SC1) centralized: This part is drafted by: Ningbo Xinyuan Dental Instrument Co:, Ltd:, State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection test center: The main drafters of this section: Fan Xiang, Wan Yiyi, Wang Haijuan, Yuan Yilin, Ruan Zhimeng, Yuan Biyu: YY 0302:2-2016

Introduction

This part is one of a series of standards on dental rotary instruments: This standard includes revisions to the requirements for carbide dressing burs: The requirements for steel dressing burs remain unchanged: Dimensional and other requirements for steel dressing burs and carbide dressing burs specified in this standard are considered to be It is very important to ensure the interchangeability and safe use of these burs in dental practice: The nominal diameters of the working parts listed in Table 1 to Table 68 are consistent with the diameters specified in YY/T 1011-2014: It should be noted that the YY/T 0783 standard provides a fifteen-digit number coding system, which is used to divide all types of dental rotations: instrument: YY 0302:2-2016 Dental rotary instrument bur Part 2: Repairing burs

1 Scope

This part of YY 0302 specifies the dimensions and related requirements of the 17 most commonly used steel and hard alloy dressing burs, including Including quality control requirements and labeling requirements for these devices:

2 Normative references

The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 6682-2008 Analytical Laboratory Water Specifications and Test Methods (ISO 3696:1987, MOD) YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical devices (ISO 13402:1995, MOD) YY 0967:1-2015 Dental Rotary Instrument Rods Part 1: Metal Rods (ISO 1797-1:1992, MOD) YY/T 0873:1-2013 Digital coding system for dental rotary instruments Part 1: General characteristics (ISO 6360-1:2004, IDT) YY/T 0873:3-2014 Digital coding system for dental rotary instruments Part 3: Characteristics of burs and knives (ISO 6360-3: 2005, IDT) YY/T 0874-2013 Test method for dental rotating instruments (ISO 8325:2004, IDT)

3 categories

Depending on the material of the working part, steel and carbide dressing burs are divided into the following two types: ---Type 1: steel trimming burs; ---Type 2: Carbide bur for dressing:

4 symbols

This section uses the following symbols: d1 working part diameter, head diameter; d2 neck diameter; d3 tip diameter; l1 working part length, head length; l2 total length; α Working part angle:

5 requirements

5:1 Materials 5:1:1 Working part The working part of steel dressing burs shall be made of steel, and the working part of carbide dressing burs shall be made of cemented carbide: material YY 0302:2-2016

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