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Dentistry--Endodontic instruments--Part 5: Shaping and cleaning instruments
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YY/T 0803.5-2016
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Basic data Standard ID | YY/T 0803.5-2016 (YY/T0803.5-2016) | Description (Translated English) | Dentistry--Endodontic instruments--Part 5: Shaping and cleaning instruments | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C33 | Word Count Estimation | 11,172 | Date of Issue | 2016-07-29 | Date of Implementation | 2017-06-01 | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | Issuing agency(ies) | State Food and Drug Administration |
YY/T 0803.5-2016: Dentistry--Endodontic instruments--Part 5: Shaping and cleaning instruments---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 5. Shaping and cleaning instruments
ICS 11.060.20
C33
People's Republic of China Pharmaceutical Industry Standard
Dental root canal instruments
Part 5. Forming and cleaning equipment
Part 5. Shapingandcleaninginstruments
(ISO 3630-5..2011, IDT)
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface I
Introduction II
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
Category 1
5 request 1
6 sampling 6
7 Test 6
8 name, identification and identification
9 Packing 6
10 Instructions for use 6
11 tags 6
Reference 7
Foreword
YY/T 0803 "dental root canal instrument" standard consists of the following five parts.
- Part 1. General requirements and test methods;
- Part 2. Amplifier;
- Part 3. Presses;
- Part 4. Auxiliary equipment;
- Part 5. Forming and cleaning equipment.
This part is part 5 of YY/T 0803.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part uses the translation method equivalent to ISO 3630-5..2011 "Dentistry Root canal equipment Part 5. Forming and cleaning equipment"
(English version).
In this part of the normative reference to the international documents have a consistent correspondence between the following documents.
GB/T 9937 (all parts) oral vocabulary [(ISO 1942 (all parts)].
This section makes the following editorial changes.
--- Some editing formats have been modified in accordance with GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part of the National Dental Material and Equipment Standardization Technical Committee of Dental Equipment and Instruments Subcommittee (SAC/TC99
SC1).
This part of the drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Shenzhen speed technology development
Limited company.
The main drafters of this part. Li Weisong, Liu Zhongyou, Huang Yanhong, Wang Zhong.
Introduction
This section does not include specific qualitative and quantitative indicators to avoid biological hazards. On possible biology or toxicology
Hazardous Related Suggestions Reference GB/T 16886.1 (ISO 10993-1) and YY/T 0268 (ISO 7405).
It should be noted that YY/T 0873 provides a set of digital coding system, provides a 15-bit coded number, used to distinguish between various types
Of the dental rotating device.
Dental root canal instruments
Part 5. Forming and cleaning equipment
1 Scope
This part is suitable for root cannula forming in hand or electric, for root canal operation and not included in YY 0803.1 ~ YY 0803.4
And cleaning equipment, this part of the specification size, logo, product design, safety indicators, labeling and packaging requirements and testing methods.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
YY 0803.1-2010 Dentistry Root canal equipment - Part 1. General requirements and test methods (ISO 3630-1..2008, IDT)
ISO 1942 Dentistry-Vocabulary
3 terms and definitions
The terms and definitions given in ISO 1942 and YY 0803.1-2010 apply to this document.
4 classification
According to YY 0803.1-2010 in Chapter 4, root canal forming and cleaning equipment is divided into five categories.
5 request
5.1 Materials
Root canal forming and cleaning equipment working parts, rod and handle material specified by the manufacturer, should be consistent with YY 0803.1-2010 5.7
Claim.
5.2 Dimensions
5.2.1 Overview
The nominal diameter and taper of the root canal forming and cleaning apparatus shall comply with the requirements of Chapter 5 of YY 0803.1-2010.
Type 2, Type 3, Type 4, and Type 5 The diameter of the identification diameter shall not exceed 50% of the difference between the adjacent two dimensions.
5.2.2 Diameter
Root canal forming and cleaning equipment diameter should be consistent with the relevant provisions of YY 0803.1-2010.
5.2.3 Length
Root canal forming and cleaning equipment length should be consistent with the relevant provisions of YY 0803.1-2010, according to YY 0803.1-2010 7.3
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