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YY 0717-2023 English PDF

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Q: Should I purchase the latest version YY 0717-2023?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0717-2023 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.

US$299.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0717-2023: Dentistry - Root canal sealing materials
Status: Valid

YY 0717: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0717-2023	299	Add to Cart	3 days	Dentistry - Root canal sealing materials	Valid
YY 0717-2009	344	Add to Cart	3 days	Dental root canal sealing materials

Similar standards

YY/T 0823 YY/T 0824 YY 0803.1 YY 0271.2 YY 0714.2

Basic data

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: 15,161
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Older Standard (superseded by this standard): YY 0717-2009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 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: Dentistry - Root canal sealing materials

---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 11.060.10 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

PrefaceⅠ Introduction III 1 Scope 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

Foreword

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0717-2023_English be delivered?

Answer: Upon your order, we will start to translate YY 0717-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0717-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0717-2023_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+ countries

Question 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 Sales@ChineseStandard.net. 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 0717-2023?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0717-2023 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.