YY/T 1280-2015 English PDF

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YY/T 1280-2015: Dentistry - Denture adhesives
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1280-2015	419	Add to Cart	4 days	Dentistry - Denture adhesives	Valid

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Basic data

Standard ID: YY/T 1280-2015 (YY/T1280-2015)
Description (Translated English): Dentistry - Denture adhesives
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 20,226
Date of Issue: 2015-03-02
Date of Implementation: 2016-01-01
Quoted Standard: GB/T 6682; GB/T 7408; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; GB/T 24404; ISO 7823-2
Adopted Standard: ISO 10873-2010, MOD
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard specifies the denture adhesive agent; also provides a description of the product requirements, test methods, and use of such products to offer. This Standard applies to denture adhesive agent used by the public.

YY/T 1280-2015: Dentistry - Denture adhesives

---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.Denture adhesives ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Dentistry Denture Adhesive (ISO 10873.2010, MOD) Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This revised standard adopts ISO 10873.2010 "Dentistry Denture Adhesive." This standard and ISO 10873.2010 major differences and the reasons are as follows. --- Increase cited the "People's Republic of China Pharmacopoeia" (2010 version) (see Appendix A, Appendix B); --- Increased references GB/T 24404-2009 (see A.3); --- Delete ISO 10873. 5.1.3 in terms of content and microbial 2010, is amended as 5.1.3 microbiological criteria; --- Table 1 increased microbial indicator; --- Added "5.1.5 heavy metal content," the technical specifications; --- Added Appendix A (normative) "microbial limits test methods"; --- Added Appendix B (normative) "heavy metal limits test methods"; --- The ISO 10873.2010 in the "requirements of Table 1" to "2 - Test methods and requirements for table correspondence table." Information on normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, adjust the set As reflected in Chapter 2, "Normative references", the specific adjustments are as follows. ● laboratory use - Specification and test methods (GB/T 6682-2008, ISO 3696. 1987, MOD) GB/T 6682 analysis; ● GB/T 7408 Data elements and interchange formats - Information interchange the date and time notation (GB/T 7408-2005, ISO 8601. 2000, IDT); ● GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)]. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Standardization Technical Committee materials and oral appliances and equipment (SAC/TC99) centralized. This standard was drafted. North State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Nisshin Dental Materials (Kunshan) Ltd., Sichuan biomaterials and medical devices products inspection center. The main drafters of this standard. Lin Hong, Xu Yongxiang Shen Xi Wei, Deng Xiang Xu Zhengguo, Zhang Dianyun. Dentistry Denture Adhesive

1 Scope

This standard Denture Adhesive removable partial denture wearers use are classified; at the same time provides the product requirements, test methods And instructions for using these products offer. This standard applies to Denture Adhesive public use, not including dental soft lining material prescription or professional dentists use. This standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards, the see ISO 7405 and ISO 10993-1.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 6682 analytical laboratory use specifications and test methods (GB/T 6682-2008, ISO 3696. 1987, MOD) GB/T 7408 Data elements and interchange formats - Information interchange the date and time notation (GB/T 7408-2005, ISO 8601. 2000, IDT) GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)] GB/T 24404 cosmetics aerobic mesophilic bacteria detection and counting People's Republic of China Pharmacopoeia (2010 edition) ISO 7823-2 plastic polymethyl methacrylate plate type, dimensions and characteristics - Part 2. squeeze plate [Plastics-Poly (Methylmethacrylate) sheets-Types, dimensionsandcharacteristics-Part 2. Extrudedsheets]

3 Terms and Definitions

GB/T 9937 defined by the following terms and definitions apply to this document. 3.1 Denture Adhesive dentureadhesives Removable denture placed concave (tissue surface) for the temporary improvement (dentures) and soft tissue support the retention of dental products. 3.2 Gum type gluetype A water-soluble polymer adhesive component in powder, paste, sheet or strip of Denture Adhesive. 3.3 Liner type linertype Non-water-soluble paste Denture Adhesive. Category 4 In this standard, Denture Adhesive is divided into the following types. a) Type 1. gum type. ......

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