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YY/T 0803.2-2020: Dentistry - Endodontic instruments - Part 2: Enlargers
Status: Valid YY/T 0803.2: Evolution and historical versions
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Dentistry - Endodontic instruments - Part 2: Enlargers
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YY/T 0803.2-2020
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| YY/T 0803.2-2010 | English | 679 |
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Dentistry. Canal instruments. Part 2: Enlargers
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YY/T 0803.2-2010
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PDF similar to YY/T 0803.2-2020
Basic data | Standard ID | YY/T 0803.2-2020 (YY/T0803.2-2020) | | Description (Translated English) | Dentistry - Endodontic instruments - Part 2: Enlargers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 22,287 | | Date of Issue | 2020-06-30 | | Date of Implementation | 2021-12-01 | | Issuing agency(ies) | State Drug Administration | YY/T 0803.2-2020: Dentistry - Endodontic instruments - Part 2: Enlargers---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.
Dentistry - Endodontic instruments - Part 2.Enlargers
ICS 11.060.20
C33
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0803.2-2010
Root canal instruments in dentistry. Part 2.Expanded drill
2020-06-30 released
2021-12-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
Introduction Ⅴ
1 Scope 1
2 Normative references 1
3 Terms, definitions and symbols 1
3.1 Terms and definitions 1
3.2 Symbol 1
4 Category 2
4.1 B1 type expansion drill 2
4.2 B2 type expansion drill 2
4.3 G-type expansion drill 2
4.4 M-type expansion drill 2
4.5 P-type expansion drill 2
5 Requirements 2
5.1 Material 2
5.2 Dimensions, markings and number of cutting edges 2
5.3 Mechanical performance requirements 8
6 sampling 9
7 Experiment 9
7.1 Overview 9
7.2 Size 9
7.3 Torsion resistance 9
7.4 Flexural performance 9
7.5 Fatigue resistance 10
7.6 Break location 10
8 Product identification, marking and identification 12
9 Packaging 13
10 Label 13
Reference 14
Foreword
YY/T 0803 "Dental Canal Instruments" consists of the following 5 parts.
---Part 1.General requirements and test methods;
---Part 2.Expand the drill;
---Part 3.Pressurizer;
---Part 4.Auxiliary equipment;
---Part 5.Shaping and cleaning equipment.
This part is part 2 of YY/T 0803.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0803.2-2010 "Dental Root Canal Instruments Part 2.Enlarger", and YY/T 0803.2-
Compared with.2010, the main technical changes except for editorial changes are as follows.
---Modified the standard name, "Amplifier" changed to "Expanded drill";
---Modified the content of the scope of Chapter 1 (see Chapter 1, Chapter 1 of the.2010 edition);
--- Added normative reference documents GB/T 9937, YY/T 0466.1 (see Chapter 2);
--- Deleted the normative reference document GB/T 7408 (see Chapter 2 of the.2010 edition);
--- Replace ISO 1797-1 with YY/T 0967.1 which is modified to adopt the international standard (see Chapter 2, 5.1.1, 5.2, 7.2.3, Chapter 2 of the.2010 edition, 4.1.1, 4.2.2, 4.2, 6.2.3);
--- Replace ISO 1797-2 with YY/T 0967.2 which is modified to adopt international standards (see Chapter 2, 5.1.1, 7.2.3, Chapter 2 of the.2010 edition, 4.2.2, 6.2.3);
--- Added classification (see Chapter 4);
---Modified the torsion, bending and fatigue resistance test (see Table 11, Table 11 of the.2010 edition);
---Modified the introduction sequence, figure and table position of various expansion drills in 5.2 (see 5.2, 4.2 in.2010 edition);
---Added the requirements for the material of the rod or handle (see 5.1.1);
---Modified the overview of the size, marking and number of cutting edges (see 5.2.1, 4.2.3.1 of the.2010 edition);
--- Modify the tolerance of l1 (see Table 1, Table 3, Table 5, Table 7 and Table 9,.2010 edition of Table 1, Table 3, Table 5, Table 7 and Table 9);
---Modified the tolerances of d2 and d3 in Table 3, the range of l2 of the nominal specification 105 in Table 3, the range of l4 in Table 4, the tolerance of d3 in Table 5, the tolerance of d2 in Table 7 (see 5.2, 4.2 of the.2010 edition);
---Modified "torsional strength" to "torsional performance", modified "bending strength" to "bending performance", and modified "fatigue strength" to
"Fatigue resistance" (see 5.3.1, 5.3.2, 5.3.3, 7.3, 7.4, 7.5, 4.3.1, 4.3.2, 4.3.3, 6.3, 6.4, 6.5 of the.2010 edition);
---Revised the sampling number (see Chapter 6, Chapter 5 of the.2010 edition);
--- Modified "twist in a clockwise direction" to "twist in its working direction" (see 7.3, 6.3 of the.2010 edition).
This section adopts the redrafting method to modify and adopt ISO 3630-2.2013 "Dental root canal instruments Part 2.Expanded drill".
The technical differences between this part and ISO 3630-2.2013 and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace ISO 1942 (all parts) with GB/T 9937 (all parts). The degree of consistency between the parts of the two standards is as follows.
● GB/T 9937.1-2008 Oral Vocabulary Part 1.Basic and clinical terms (ISO 1942-1.1989, IDT);
● GB/T 9937.2-2008 Dental Vocabulary Part 2.Dental Materials (ISO 1942-2.1989, IDT);
● GB/T 9937.3-2008 Dental Vocabulary Part 3.Dental Devices (ISO 1942-3.1989, IDT);
● GB/T 9937.4-2005 Dental Terminology Part 4.Dental Equipment (ISO 1942-4.1989, IDT);
● GB/T 9937.5-2008 Oral Vocabulary Part 5.Terms related to testing (ISO 1942-5.1989, IDT).
● Replace ISO 15223-1 with YY/T 0466.1 equivalent to the international standard (see Chapter 10);
● Replace ISO 3630-1.2008 with YY 0803.1-2010 equivalent to the international standard (see Chapter 1, 3.1, 5.1.1,
5.2.1, 7.1, 7.3, 7.4, Chapter 9, Chapter 10);
● Replace ISO 1797-1 (see Chapter 2, 5.1.1, 5.2, 7.2.3) with YY/T 0967.1 which is modified to adopt international standards;
● Replace ISO 1797-2 with YY/T 0967.2 which is modified to adopt international standards (see Chapter 2, 5.1.1, 7.2.3);
---Modified the "expansion drill clockwise twist" in 7.3 to "turn according to the working direction of the expansion drill", the working direction of the expansion drill is different
It is always clockwise. The torsion resistance test is to test the torsion resistance of the expander drill during use, so it is more appropriate to twist according to the working direction of the expander drill.
This section has made the following editorial changes.
--- Modify the "Figure 1-4" of 5.3.4 to "Figure 1-3 and Figure 5";
--- Amend 7.2.2 "Table 1, Table 3 and Table 9" to "Table 5, Table 7 and Table 9", "Figure 1, Figure 2 and Figure 5" to "Figure 3, Figure 4 and Figure 5";
--- Modify "Figure 1, Figure 2 and Figure 3" in 7.5 to "Figure 1, Figure 3 and Figure 5";
--- Modify "Figure 1-4" in 7.6 to "Figure 1-3 and Figure 5";
--- Modify the tolerance "-0.05,0" of d2 in Table 5 to "0, 0.05", communicate with the ISO standard drafting team, and confirm it as an editorial error;
--- Modify the "maximum torque mN·m" of the bending test in Table 11 to "deflection angle (°)", communicate with the ISO standard drafting team, and confirm it as an editorial error;
---Added "see Figure 6" in 7.3, deleted "see Figure 6" in 7.5, Figure 6 shows the clamping position of torsion resistance, 7.5 fatigue resistance
The performance does not need to clamp the working part of the sample, communicate with the ISO standard drafting team, and confirm it as an editorial error;
--- Modified "Record the maximum torque value in mN·m" in 7.4 to "Record the permanent angular offset value", which is consistent with the ISO standard
The quasi-drafting team communicated and confirmed it as an editorial error.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Dental Materials and Equipment Standardization Technical Committee Dental Equipment and Equipment Subcommittee (SAC/TC99 SC1).
Drafting organizations of this section. Guangdong Medical Device Quality Supervision and Inspection Institute, Shenzhen Suhang Technology Development Co., Ltd.
The main drafters of this section. Huang Minju, Li Jiyan, Huang Yuzhe, Tang Zhi, Wang Yiye, Wang Zhong.
The previous releases of the standards replaced by this part are.
---YY/T 0803.2-2010.
Introduction
This section includes the main features of the "enlarged drill" in dental root canal treatment instruments (hand and machine). These dental appliances
Prepare root canals to prepare for follow-up treatment. In dentistry, these instruments can also be called root canal instruments.
This section specifies the expansion drill in root canal instruments. The expanding drill is used to open the crown of the root canal and expand the mouth of the root canal.
This section does not specify the relevant requirements for the biological performance of the product. It is recommended that the biological evaluation of the product be carried out in accordance with GB/T 16886.1 and YY/T 0268.
It should be noted that. YY/T 0873.5 specifies a 15-digit digital code to identify all types of dental rotary instruments.
Root canal instruments in dentistry. Part 2.Expanded drill
1 Scope
This part of YY/T 0803 stipulates that there is no in YY 0803.1-2010, YY 0803.3, YY/T 0803.4, YY/T 0803.5
The specific requirements of the expansion drill mentioned. This part also specifies the size, marking, product identification, safety precautions, labels and packaging of the expanded drill.
Include specific requirements for instructions for use.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)]
YY/T 0466.1 Medical devices are used for medical device labeling, marking and information symbols. Part 1.General requirements
(YY/T 0466.1-2016,ISO 15223-1.2012,IDT)
YY 0803.1-2010 Dental root canal instruments Part 1.General requirements and test methods (ISO 3630-1.2008, IDT)
YY/T 0967.1 Rotary dental instrument rod Part 1.Metal rod (YY/T 0967.1-2015, ISO 1797-1.1992, MOD)
YY/T 0967.2 Dental rotating instrument rod Part 2.Plastic rod (YY/T 0967.2-2015, ISO 1797-2..1992, MOD)
3 Terms, definitions and symbols
3.1 Terms and definitions
The following terms and definitions defined in GB/T 9937 and YY 0803.1-2010 apply to this document.
3.1.1
Expand drill
A hand or machine root canal instrument used to open and expand the root canal opening from the crown of the root canal to enter the root canal channel.
Note. Expanding drill is also called expander.
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