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YY 0271.1-2016 English PDF

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YY 0271.1-2016: Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
Status: Valid

YY 0271.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0271.1-2016English499 Add to Cart 4 days [Need to translate] Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements Valid YY 0271.1-2016
YY 0271.1-2009English839 Add to Cart 4 days [Need to translate] Dentistry-Water-based cements. Part 1: Power/liquid acid-base cements Obsolete YY 0271.1-2009
YY 0271-1995English519 Add to Cart 4 days [Need to translate] Dental water-based cements Obsolete YY 0271-1995

PDF similar to YY 0271.1-2016


Standard similar to YY 0271.1-2016

YY 0270.1   YY 0304   YY/T 0268   YY 0271.2   YY 0272   YY/T 0273   

Basic data

Standard ID YY 0271.1-2016 (YY0271.1-2016)
Description (Translated English) Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 25,235
Date of Issue 2009-06-16
Date of Implementation 2018-06-01
Adopted Standard ISO 9917-1-2007, MOD
Regulation (derived from) State Food and Drug Administration Notice 2016 (No. 129)
Issuing agency(ies) State Food and Drug Administration
Summary This section specifies the technical requirements and test methods for use as permanent cement, bottom/lining and repair of dental powder/liquid acid base. This part of YY 0271 is also suitable for hand-blended water-based cements or mechanically tuned capsules. This section sets limits for each performance as it is intended for use as a cement, bottom or lining or repair material. This part does not apply to resin-modified water-based cements.

YY 0271.1-2016: Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements

---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 - Water-based cements - Part 1. Powder/liquid acid-base cements ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0271.1-2009 Dental water - based cement Part 1. powder/liquid acid base cement Part 1. Powder/liquidacid-basecements (ISO 9917-1..2007. MOD) 2016-07-29 released 2018-06-01 implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Category 1 5 material 2 6 Sample preparation 2 7 sampling 3 8 requirements 3 9 Packaging, identification and information provided by the manufacturer 4 Appendix A (informative) Chemical composition and application of dental cements 6 Appendix B (normative) Test for net cure time 7 Appendix C (normative) Test of film thickness (only for cementing cements) 8 Appendix D (normative) Test for compressive strength 10 Appendix E (normative appendix) Test of acid etching 12 Appendix F (informative) Test of optical properties (optical properties) (only for the repair of polyalkenylate glass cements) 15 Appendix G (normative) Test for optical properties (color) (only for polyacrylate glass cements for repair) 16 Appendix H (Normative Appendix) Test for Acid Soluble Arsenic Content and Lead Content Appendix I (normative appendix) X-ray resistance test 18 Reference 20

Foreword

The technical content of this standard is mandatory. YY 0271 "Dental Water-based Water Pavilion" consists of two parts. - Part 1. powder/liquid acid and alkali; - Part 2. Resin modified. This part is part 1 of YY 0271. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section replaces YY 0271.1-2009 "Dental Water-based Cementing Part 1. Powder/Acid-Base Alkaline". The main technical changes in this section and YY 0271.1-2009 are as follows. --- increase the X-ray resistance of the test and requirements; - the requirements of the manual reconcile the requirements of the requirements of the cement and the cements of the cement factory, --- increase the opacity of the test and requirements; --- increase the color of the test and requirements; - arsenic content test method based on the "by the People's Republic of China Pharmacopoeia (2005 edition) in the method" to "in accordance with the ISO 2590 method (Arbitration Act) or by the People's Republic of China Pharmacopoeia (2010 edition) method of testing arsenic content "; - laboratory analysis of water, from "deionized water or distilled water" to ISO 9917-1..2007 ISO 3696. 1987, Level 3 water; --- Added reference. This part of the modified use of ISO 9917-1..2007 "dental water-based cement Pavilion Part 1. powder/liquid acid alkali cement." The main differences between this section and ISO 9917-1..2007. - delete 8.5a in ISO 9917-1..2007) and its contents; - Appendix F is split into Appendix F and Appendix G, Appendix F becomes informative, and the serial numbers of the appendix are extended in sequence; The test method of arsenic content has increased the content of the method according to the method of the Pharmacopoeia of the People's Republic of China (2010 edition). In this part of the normative reference to the international documents have a consistent correspondence between the following documents. Analysis of laboratory water specifications and test methods (ISO 3696. 1987, MOD); GB/T 6682-2008; Determination of color stability of dental materials (ISO 7491..2000, IDT) YY/T 0631-2008. 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 is headed by the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99). This part of the drafting unit. the State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center, Shanghai Second Medical Zhangjiang Biomaterials Materials Co., Ltd., Wuhan University School of Stomatology oral medicine materials plant. The main drafters of this section. Zhang Dianyun, Zheng Gang, Jiang Lan, Zhang Guoqing, Xia Jun, Yuan Shenpo This part of the replacement of the previous version of the standard release. YY 0271-1995, YY 0271.1-2009.

Introduction

This section does not contain qualitative and quantitative requirements for the assessment of biological hazards. When evaluating possible biological or toxicological hazards, Use ISO 7405 and ISO 10993-1. Dental water - based cement Part 1. powder/liquid acid base cement

1 Scope

This part of YY 0271 specifies the technical requirements for permanent cementing, bottoms/lining and repair of dental powder/liquid acid base And test methods. This part of YY 0271 is also suitable for hand-blended water-based cements or mechanically tuned capsules. This section sets limits for each performance as it is intended for use as a cement, bottom or lining or repair material. Headquarters Points do not apply to resin-modified water-based cement.

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. ISO 2590 General method for the determination of arsenic content Diethyldithiocarbamate photometric method (Generalmethodforthe determinationofarsenic-silverdiethyldithiocarbamatephotometricmrthod) ISO 3665..1996 Photography-Intra-oraldentalra- diographicfilm-Specification ISO 3696 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specification andtestmethods) ISO 7491 Determination of color stability of dental materials (Dentalmaterials-Determination ofcolourstability)

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Reconciliation time The components meet the part of the time required for adequate mixing. 3.2 Working hours A period of time from the time of reconciliation (if required), during which time the engine can be operated and has no adverse effect on its performance. 3.3 Net cure time netsettingtime The time required for the end of the self-tuning time to reach the material in accordance with the parameters and conditions specified in Appendix A. Note. Based on the purpose of this part of YY 0271, taking into account the different mixing time difference between the different cement, the net curing time is from the end of the reconciliation time Timing.

4 classification

4.1 Chemical classification The chemical composition of dental cement and its application is given in Appendix A. For the purposes of this section, dental fittings are based on chemical composition

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