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YY/T 0803.3-2016: Dentistry-Root-canal instruments --Part 3: Codensers
Status: Valid YY/T 0803.3: Evolution and historical versions
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Dentistry-Root-canal instruments --Part 3: Codensers
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Basic data | Standard ID | YY/T 0803.3-2016 (YY/T0803.3-2016) | | Description (Translated English) | Dentistry-Root-canal instruments --Part 3: Codensers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 13,130 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2018-01-01 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements and test methods for vertical and lateral presses used for compacting root canal filling materials. In addition to standard specifications, tapered specifications are also included. This type of tapered gauge is determined by the degree of taper that varies with the size of the instrument. | YY/T 0803.3-2016: Dentistry-Root-canal instruments --Part 3: Codensers---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.
ICS 11:060:20
C33
Pharmaceutical Industry Standard of the People's Republic of China
YY 0803:3-2016
Dentistry endodontic instruments part 3 : pressurizers
Dentistry-Root-canalinstruments-Part 3:Condensers
(ISO 3630-3:1994Dentalroot-canalinstruments-
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:
2016-01-26 release:2018-01-01 implementation
Issued by China Food and Drug Administration
foreword
All technical content of this section is mandatory:
"Dentistry Endodontic Instruments" consists of the following 4 parts:
---Part 1: General requirements and test methods (YY 0803:1);
--- Part 2: Amplifier (YY/T 0803:2);
--- Part 3: Pressurizer (YY 0803:3);
--- Part 4: Auxiliary devices (YY/T 0803:4);
--- Part 5: Forming and cleaning (YY/T 0803:5):
This part is part 3:
This section is drafted in accordance with the rules given in GB/T 1:1-2009:
This part is modified to adopt ISO 3630-3:1994 "Dental endodontic instruments - Part 3: Pressurizers, vertical pressers and lateral pressurizers
Device": The main differences between this part and ISO 3630-3:1994 are as follows:
--- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments
Centrally reflected in Chapter 2 "Normative References", the specific adjustments are as follows:
● Use YY 0803:1-2010 "Dental endodontic instruments Part 1: General requirements and test methods" (ISO 3630-1:
2008, IDT) to replace ISO 3630-1:1992 "Dental rotary instruments Part 1: Root canal files, expanders, barbed pulp extraction
Needles, rasps, paste feeders, probes and cotton twists";
● Replace ISO 6360-1:1985 "Dental
Digital coding system for rotating instruments - Part 1: General characteristics";
--- Split ISO 3630-3:1994 Figure 3 into Figure 3 and Figure 4;
--- The taper mark is represented by a percentage:
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 prepared by the Dental Equipment and Instruments Sub-Technical Committee of the National Dental Materials and Instruments Standardization Technical Committee (SAC/TC99/
SC1) proposed:
This part is prepared by the Dental Equipment and Instruments Sub-Technical Committee of the National Dental Materials and Instruments Standardization Technical Committee (SAC/TC99/
SC1) centralized:
This part is drafted by: State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shenzhen Suhang Technology Development
Ltd:
The main drafters of this section: Lu Wenjuan, Wang Zhong, Li Danrong, Yuan Qin:
YY 0803:3-2016
Introduction
YY 0803 covers the important features of hand-held endodontic instruments for root canal preparation:
In addition to special instruments, YY 0803:1 contains the general characteristics, requirements and test methods of all types of endodontic instruments:
It is worth noting that YY/T 0873 "Digital Coding System for Dental Rotary Instruments" provides a set of digital coding system, which stipulates
15 digits used to distinguish various types of dental rotary instruments:
YY 0803:3-2016
Dentistry endodontic instruments part 3 : pressurizers
1 Scope
This part of YY 0803 specifies the requirements and test methods for vertical pressers and lateral pressers used for compacting root canal filling materials:
In addition to standard specifications, tapered specifications are also included: This type of tapered gauge is determined by the degree of taper that varies with the size of the instrument:
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 9937:3-2008 Oral Vocabulary Part 3: Dental Devices (ISO 1942-3:1989, IDT)
YY 0803:1-2010 Dental endodontic instruments Part 1: General requirements and test methods (ISO 3630-1:2008, IDT)
YY/T 0873 (all parts) Digital coding system for dental rotary instruments [ISO 6360 (all parts), IDT]
3 Terms and Definitions
The terms and definitions defined in GB/T 9937:3 and the following terms and definitions apply to this document:
3:1
root canal filling pressurizer root-canalfilingcondenser
The working part is cylindrical or conical, and the cross section is a hand-held instrument: For vertical and/or lateral compaction of root canal filling material: add
Pressers are usually divided into vertical pressers and side pressers:
Note: Hand-held devices include finger-held devices and hand-held devices:
3:2
root canal filling vertical presser root-canalfilingplugger
The working part is cylindrical or conical, the cross-section is circular, and the end surface is a hand-held instrument with a flat surface: Primarily used for vertically compacted root canal fillings
Material:
3:3
root canal filling lateral pressure device root-canalfilingspreader
The working part is conical, the section is circular, and the end is a pointed hand-held instrument: Mainly used for lateral compaction of root canal filling materials:
4 requirements
4:1 Materials
The operating parts of the device shall be made of corrosion-resistant materials: The type of material and the method of treatment are specified by the manufacturer:
The handle or rod shall be plastic material or other corrosion-resistant material, the material shall be selected by the manufacturer:
4:2 Dimensional requirements for standard vertical pressers and standard side pressers
4:2:1 General
Dimensions are in millimeters:
YY 0803:3-2016
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