|
US$459.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0803.1-2022: Dentistry - Endodontic instrument - Part 1: General requirements
Status: Valid YY/T 0803.1: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0803.1-2022 | English | 459 |
Add to Cart
|
4 days [Need to translate]
|
Dentistry - Endodontic instrument - Part 1: General requirements
| Valid |
YY/T 0803.1-2022
|
| YY 0803.1-2010 | English | 260 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Dentistry. Root-canal instruments. Part 1: General requirements and test methods
| Obsolete |
YY 0803.1-2010
|
PDF similar to YY/T 0803.1-2022
Basic data | Standard ID | YY/T 0803.1-2022 (YY/T0803.1-2022) | | Description (Translated English) | Dentistry - Endodontic instrument - Part 1: General requirements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 22,293 | | Issuing agency(ies) | State Drug Administration | YY/T 0803.1-2022: Dentistry - Endodontic instrument - Part 1: General requirements---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 instrument - Part 1.General requirements
ICS 11.060.20
CCSC33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0803.1-2010
Dental root canal instruments
Part 1.General Requirements
(ISO 3630-1.2019, MOD)
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface I
Introduction III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Category 3
5 Requirements 3
6 Sampling 11
7 Test methods 11
8 Identification, marking and identification 15
9 packs of 16
10 Instructions for use 16
11 Tags 16
Reference 17
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document is part 1 of YY/T 0803 "Dental root canal instruments". YY/T 0803 has issued the following parts.
--- Part 1.General requirements;
--- Part 2.Expanding drills;
--- Part 3.Pressurizers;
--- Part 4.Assistive devices;
--- Part 5.Forming and cleaning instruments.
This document replaces YY 0803.1-2010 "Dental root canal instruments - Part 1.General requirements and test methods". and
Compared with YY 0803.1-2010, in addition to structural adjustment and editorial changes, the main technical changes are as follows.
--- Delete the definitions of flexible devices and guiding devices (3.1.8 and 3.1.9 of the.2010 edition);
--- Added the definition of connecting rod (see 3.1.10);
--- Changed the symbol (see 3.2, 3.2 of the.2010 edition);
--- Change "Type 3.Shaped instruments" to "Type 3.Non-tapered instruments" (see Chapter 4 and 5.4, Chapter 4 and 5.4 of the.2010 edition);
--- Change "Type 4.Non-tapered instruments" to "Type 4.Non-single-tapered instruments" (see Chapters 4 and 5.5, Chapter 4 and.2010 Edition)
5.5);
--- Change "Type 5.Non-single taper instruments" to "Type 5.Shaped instruments" (see Chapter 4 and 5.6, Chapter 4 and 5.6 of the.2010 edition);
--- Added the schematic diagram of non-single taper instruments (see Figure 4);
--- Changed the requirements for handles and rods (see 5.8.3, 5.8.3 of the.2010 edition);
--- Added a schematic diagram of the rod size (see Figure 6);
--- Added the tolerance list of rod dimensions (see Table 2);
--- Changed the reliability of the handle and rod (see 5.9.3, 5.9.3 of the.2010 edition);
--- Deleted chemical properties (5.10 of the.2010 edition);
--- Increased tolerance to repeated treatment (see 5.10 and 7.7);
--- Changed sampling (see Chapter 6, Chapter 6 of the.2010 edition);
--- Changed the calculation of taper (see 7.3.4, 7.3.4 of the.2010 edition);
--- Changed "Chuck with soft brass jaws" to "Chuck with jaws" (see 7.4.2.2 and Figure 7, 7.4.2.1.3 and Figure 5 of the.2010 edition);
--- Change "clockwise direction" to "device working direction" (see 7.4.3, 7.4.3 of the.2010 edition);
--- Change "tighten the operating part, leaving 3mm outside" to "tighten the operating part within 1mm from the handle or rod" (see
7.6.4.1, 7.6.4.1 of the.2010 edition);
--- Deleted the heat effect of corrosion test and sterilization (7.7 and 7.8 of the.2010 edition);
--- Added the identification symbol of double cutting edge (diamond) and double helix type H file (see Figure 10);
--- Deleted the manufacturer's applicable instructions f) (see Chapter 10 of the.2010 edition);
--- Change "whether the device is used alone" to "whether the device is single-use" (see Chapter 11, Chapter 11 of the.2010 edition).
This document uses the redrafting method to modify and adopt ISO 3630-1.2019 "Dental root canal instruments - Part 1.General requirements".
The technical differences between this document and ISO 3630-1.2019 and their reasons are as follows.
--- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and facilitate this article.
According to the implementation of the document, the adjustment situation is mainly reflected in Chapter 2 "Normative Reference Documents", and the specific adjustment is as follows.
● Replace ISO 8601 with GB/T 7408 which is equivalent to adopting international standards;
● Replace ISO 1942 with GB/T 9937 which has been modified to adopt international standards;
● Replace ISO 15223-1 with YY/T 0466.1 which is equivalent to adopting international standards;
● Replacing ISO 17664 with YY/T 0802 which has been modified to adopt international standards;
● Replacing ISO 1797 with YY/T 0967 which has been modified to adopt international standards;
● Replacing ISO 3630-2 with YY/T 0803.2 which has been modified to adopt international standards;
● Replacing ISO 3630-3 with YY 0803.3 modified to adopt international standards;
● Replacing ISO 3630-4 with YY/T 0803.4 which has been modified to adopt international standards;
● Replacing ISO 3630-5 with YY/T 0803.5 which has been modified to adopt international standards;
---Added "If the length of the working part is less than 16mm, the taper is the difference between the second diameter and d3 divided by the working part minus
An example of taper calculation when the value of 4mm is obtained" and the working part is less than 16mm, which helps to understand the terms of the document more accurately
(see 7.3.4);
--- Changed "Root canal instruments should be packaged as a unit or a single package" in Chapter 9 to "Root canal instruments should be packaged as a unit or
"Single package", packaging should not be mandatory.
This standard has made the following editorial changes.
--- Deleted the description of the index number 3 in Figure 8, and the mark in the figure has explained that "3" indicates the distance (see Note in Figure 8).
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is approved by the Dental Equipment and Equipment Sub-Technical Committee of the National Standardization Technical Committee for Oral Materials and Devices (SAC/TC99/
SC1) focal point.
This document is drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Shenzhen Suhang Technology Development Co., Ltd., Mani (Beijing) Trade
Easy Co., Ltd.
The main drafters of this document. Huang Minju, Li Jiyan, Zhou Liangbin, Wang Zhong, Shen Lisi, Li Menghan, Cheng Juan, Zeng Zhixiong.
The previous versions of the standards replaced by this document are as follows.
---YY 0803.1-2010.
Introduction
This document presents general requirements and test methods for endodontic instruments. YY/T 0803 series of standards specify various fields of root canal instruments
The specific requirements and test methods for this document consist of 5 parts.
--- Part 1.General requirements. The purpose is to specify root canal instruments for root canal treatment (e.g. expanding drills, presses, aids)
General Requirements and Test Methods and Numerical Coding Systems
--- Part 2.Expanded drill. The purpose is to specify the specific requirements for root canal enlargement drills.
--- Part 3.Compressor. The purpose is to specify the specific requirements for root canal compressors.
--- Part 4.Assistive devices. The purpose is to specify specific requirements for root canal aids.
--- Part 5.Forming and cleaning instruments. The purpose is to specify specific requirements for root canal shaping and cleaning instruments.
For the nickel-titanium alloy, which is widely used in the manufacture of root canal instruments, its safe application requires sufficient expertise. This document is not intended to provide
Any information on the specific application of nitinol materials in endodontic instruments.
The specifications of the root canal filling tip (cone) specified in YY/T 0495 and the specifications of root canal instruments specified in the YY/T 0803 series of standards
Corresponding.
Dental root canal instruments
Part 1.General Requirements
1 Scope
This document specifies the general rules for root canal instruments used for root canal treatment (e.g. expanding drills, presses, auxiliary instruments, shaping and cleaning instruments)
Requirements and test methods and digital coding systems.
This document also specifies general specification marking, color coding, packaging and identification symbols.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 7408 Data Element and Interchange Format Information Exchange Date and Time Representation (GB/T 7408-2005, ISO 8601.
2000, IDT)
GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD)
YY/T 0466.1-2016 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements
Seek (ISO 15223-1.2012, IDT)
YY/T 0802 Treatment of medical devices Information provided by medical device manufacturers (YY/T 0802-2020, ISO 17664.
2017, MOD)
YY/T 0803.2 Dental root canal instruments - Part 2.Enlarging drills (YY/T 0803.2-2020, ISO 3630-2.2013,
MOD)
YY 0803.3 Dental Root Canal Instruments Part 3.Compressors (YY 0803.3-2016, ISO 3630-3.1994, MOD)
YY/T 0803.4 Dental root canal instruments - Part 4.Assistive instruments (YY/T 0803.4-2015, ISO 3630-4.2009,
MOD)
YY/T 0803.5 Dental root canal instruments - Part 5.Forming and cleaning instruments (YY/T 0803.5-2016, ISO 3630-5.
2011, IDT)
YY/T 0967 Rods for rotating and reciprocating instruments in dentistry (YY/T 0967-2022, ISO 1797.2017, MOD)
ting-Specifications)
3 Terms and Definitions
The terms and definitions defined in GB/T 9937 and the following apply to this document.
3.1 Terms and Definitions
3.1.1
root canal instrument endodonticinstrument
Dental instruments for probing, shaping, cleaning and filling of root canals.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0803.1-2022_English be delivered?Answer: Upon your order, we will start to translate YY/T 0803.1-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 0803.1-2022_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0803.1-2022_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. Question 5: Should I purchase the latest version YY/T 0803.1-2022?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0803.1-2022 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
|