Search result: YY 0717-2023 (YY 0717-2009 Older version)
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Dentistry - Root canal sealing materials
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YY 0717-2023
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| YY 0717-2009 | English | 344 |
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Dental root canal sealing materials
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YY 0717-2009
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| Standard ID | YY 0717-2023 (YY0717-2023) | | Description (Translated English) | Dentistry - Root canal sealing materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 15,199 | | Date of Issue | 2023-09-05 | | Date of Implementation | 2026-09-15 | | Older Standard (superseded by this standard) | YY 0717-2009 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the performance requirements and test methods for dental root canal sealing materials used to permanently seal tooth root canals. This standard applies to the following root canal sealing materials, which can be cured in a humid or moisture-free environment, can be used in conjunction with a root canal filling tip or can be used alone without a root canal filling tip, and can be filled in a forward direction. (i.e. root canal filling from the crown of the tooth). |
YY 0717-2023. Dental root canal sealing materials
ICS 11.060.10
CCSC33
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0717-2009
Dental root canal sealing materials
(ISO 6876.2012,MOD)
Published on 2023-09-05
Implemented on 2026-09-15
Released by the State Drug Administration
Table of contents
PrefaceⅠ
Introduction III
1 range 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Requirements 2
5 Sampling 3
6 Test environment and sample preparation 3
7 Test method 3
8 Packaging, labeling and information provided by the manufacturer7
Reference 9
Preface
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces YY 0717-2009 "Dental Root Canal Sealing Materials". Compared with YY 0717-2009, except for structural adjustment and editing
In addition to the modifications, the main technical changes are as follows.
--- "Non-curing dental root canal sealing materials are not applicable to this standard." has been deleted from the scope (see Chapter 1 of the.2009 edition);
---Added the terms "root canal sealing material" (see 3.1) and "root canal filling material" (see 3.2);
---The test procedures for fluidity, working time and solubility have been changed, and the limits have been redefined (see 4.3.1, 4.3.2,
4.3.5, 4.3.1, 4.3.2, 4.3.6 of the.2009 version);
---Change the liquidity indicator to "≥17mm" (see 4.3.1,.2009 version of 4.3.1);
---Deleted the note about constant weight in the solubility step (see 7.7.3 of the.2009 version);
--- Move the description of biological hazards and ingredients claimed to have therapeutic effects from the requirements to the introduction (see Introduction, 4.2 of the.2009 version);
--- Added requirements for microbial limits (see 4.2.1);
---Changed the requirements for dimensional changes after curing (see 4.3.7, 4.3.5 of the.2009 version);
---Change part of the X-ray radiolucidity testing steps to "Test in accordance with YY/T 1646", retaining the sample preparation and structure
Results (see 7.8,.2009 version of 7.8).
This document has been modified to adopt ISO 6876.2012 "Dental Root Canal Sealing Materials".
The technical differences between this document and ISO 6876.2012 and their reasons are as follows.
---Write the sterility instructions in the introduction into the text requirements (see 4.2.2), and specify the test method (see 7.2.2);
---Replaced ISO 3696 (see 7.7.1.6) with normatively cited GB/T 6682 to adapt to my country's technical conditions and increase operability
work nature;
---Replaced ISO 1942 (see Chapter 3) with normatively quoted GB/T 9937 to adapt to my country's technical conditions and increase operability.
work nature;
---Replaced ISO 6873 (see 7.5.1.3) with normatively cited YY 0462 to adapt to my country's technical conditions and increase operability
work nature;
---Added YY/T 1646 (see 7.8) and Pharmacopoeia of the People's Republic of China 2020 Edition (see 7.2) as normative references
document;
---Removed ISO 3665;
---Change 4.2 "Microbiological hazards" to "Microorganisms and sterility" (see 4.2);
---Added 4.2.1 microbial limits;
---Added 4.3.7 Dimensional changes after curing, and specified 7.9 test method, because this indicator measures the material filling into the root canal body
The cumulative changes have an impact on the prognosis of treatment;
---Remove 4.4, 4.5, and 4.6 from the 4 requirements and change them to 5 and 6, and adjust the subsequent serial numbers accordingly, because 4.4, 4.5, and 4.6 are taken
Samples, test conditions and specimen preparation are not performance requirements;
---Added 7.3.1.4 balance, accuracy 0.0001g;
---7.7.3 and 7.7.4 add the description and expression of material disintegration to correspond to the requirements of 4.3.5;
---Change part of the 7.8
Judgment of results.
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99).
The previous versions of the documents replaced by this document are as follows.
---First released in.2009 as YY 0717-2009;
---This is the first revision.
introduction
This document does not include qualitative and quantitative test methods used to demonstrate that materials do not present unacceptable biological risks, such as the assessment of such biological
Risks can be referred to ISO 10993-1 and ISO 7405.
If the manufacturer claims that the product has therapeutic effects, the purity and sterility of the relevant ingredients must comply with the Pharmacopoeia of the People's Republic of China or appropriate
relevant laws and regulations.
Dental root canal sealing materials
1 Scope
This document specifies the performance requirements and test methods for dental root canal sealing materials used to permanently seal tooth root canals.
This document is applicable to the following root canal sealing materials, which can be cured in a humid or non-humid environment and can be used with or without root canal filling tips.
A root canal sealing material used alone in conjunction with a root canal filling tip and for forward filling (i.e. root canal filling from the crown of the tooth).
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 6682 Analytical laboratory water specifications and test methods (GB/T 6682-2008, ISO 3696.1987, MOD)
GB/T 9937 Dental terminology (GB/T 9937-2020, ISO 1942.2009, MOD)
YY 0462 Dental plaster products (YY 0462-2018, ISO 6873.2013, MOD)
YY/T 1646 Test method for X-ray radiopacity of dental materials (YY/T 1646-2019, ISO 13116.
2014,IDT)
ISO 8601 (all parts) Date and time format (Dateandtimeformat)
Note. GB/T 7408-2005 Data element and exchange format information exchange date and time representation (ISO 8601.2000, IDT)
Pharmacopoeia of the People's Republic of China 2020 Edition Four Parts
3 Terms and definitions
The terms and definitions defined in GB/T 9937 and the following apply to this document.
3.1
A root canal filling material used to permanently seal the pulp chamber of a tooth from which the pulp has been removed.
3.2
Root canal material used to permanently fill the pulp cavity occupied by the original pulp of a tooth.
3.3
mixing time mixing time
During the working time, the time to mix the components evenly.
3.4
working time working time
The time from the start of blending until the closure material can be handled without adversely affecting its properties.
3.5
Curing timesettingtime
Timing starts from the end of mixing until the time required for the sealing material to solidify according to the indicators and conditions described in 7.5.
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YY 0717-2009
Dental root canal sealing materials
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
YY 0717-2009/ISO 6876.2001
Dental root canal filling materials
(ISO 6876.2001, IDT)
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
All technical contents of this standard is mandatory.
This standard is identical with ISO 6876.2001 "dental root canal filling materials."
This standard is based on ISO 6876.2001 re-drafted in order to increase operability standards, made editorial changes.
This standard 6876.2001 major differences and the reasons are as follows.
--- Introduction of the ISO "is not cured dental root canal filling materials used in this standard does not apply to" move range.
--- Normative references in ISO 3696. 1987 to GB/T 6682-2008 "analytical laboratory use - Specification and test
method".
--- 4.2 international standards "if manufacturers claim that product sterility, the manufacturer's responsibility to provide proof of sterility. This standard does not of
Sterility requirements or test methods prescribed, recommended by the already existing national standards. If there are no national standards should be consulted
American, European or Japanese Pharmacopoeia. "Because of the use of pharmacopoeia sterility testing, so the original standards into" If the production plant
He claimed product sterility, the manufacturer's responsibility to provide proof of sterility. This standard does not carry out the provisions of aseptic requirements or test methods,
It is recommended that reference the corresponding national provisions, such as Chinese Pharmacopoeia. "
--- International standards set forth in the dimensional change test test after curing using a flat glass plate, about the size of 25mm × 75mm ×
1mm thick. But taking into account 1mm thick glass in a very easy to clip broken clamping after C-clip, so this standard 7.6.1.2
Increase "or suitable flat stainless steel plate."
--- 7.7.1.7 Add "(silica)," international standards dryer built pentoxide or other suitable desiccant, but other close
Examples of suitable drying agent was not. Silica gel desiccant is commonly used laboratory and technically consistent with the requirements of this test.
--- 7.7.3 added a definition of constant weight --- "constant weight refers to the weight of the two weighing interval 24h is less than 0.002g".
This standard was proposed by the State Food and Drug Administration.
This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment.
This standard is drafted by. State Food and Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Lin Hong, Zhang Yan, Li Yuan, Zhang Dianyun, Sun Zhihui, Bai Wei.
YY 0717-2009/ISO 6876.2001
Dental root canal filling materials
1 Scope
This standard specifies performance requirements and test methods for the permanent closure of the root canal dental root canal filling material. Dental root canal filling material
Material can be in wet or humid environment without curing, can be combined with apical root canal filling tip or use alone. This standard applies only to positive
To fill the root canal filling materials, namely, root canal filling from the tooth crown.
Not curing dental root canal filling materials does not apply to this standard.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
Laboratory use specifications and test methods GB/T 6682-2008 Analysis
ISO 3665.1996 photography dental radiographic film Specification
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
The respective components are homogeneously mixed time, it is part of the working time.
3.2
From the beginning to be able to reconcile the use of closed material and its performance is not adversely affected by time.
3.3
From the end reconcile the start time, the time until the closing press material indicators and conditions described in the 7.4 needed for curing.
Note. The curing time is from the end reconcile time starts counting, because there is time to reconcile the great differences.
4 Requirements
4.1 Composition
7.1 Test press, closed material should not contain visible foreign matter.
When you press manufacturer Manual Using the closed material formed to reconcile the components shall comply with the performance requirements.
4.2 Microbiological Hazards
This standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards when, see
Khao YY/T 0268.
If the manufacturer claims that product sterility, the manufacturer's responsibility to provide proof of sterility. This standard does not aseptic requirements or test methods into
Bank regulations, it is recommended that reference the corresponding national provisions, such as "Chinese Pharmacopoeia."
If the manufacturer claims that the product has a therapeutic effect, the purity and sterility of its components, shall comply with the relevant drug sealer sale country
Code provides, or pharmaceutical product purity and sterility shall comply with national regulations.
YY 0717-2009/ISO 6876.2001
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