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YY/T 1280-2015Dentistry—Denture adhesives (English PDF)

牙科学 义齿黏附剂

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 1280-2015 is the English-translated version of 牙科学 义齿黏附剂.

YY/T 1280-2015 is the Chinese pharmaceutical industry standard for denture adhesives, as used by those who wear a removable partial or complete denture.

It classifies these products and sets the requirements for them, the test methods and the instructions that are to be supplied with them, covering the consistency and the adhesive strength, the retention over time in a moist environment, the solubility and the substances released, the biological requirements and the labelling. Issued on 2 March 2015, it has applied since 1 January 2016.

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Document preview — YY/T 1280-2015

National Standard of the People's Republic of China

ICS
11.060.10
Classification
C 33

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions GB/T 9937 defined by the following

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)].

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

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

Non-water-soluble paste Denture Adhesive.

Category 4 In this standard, Denture Adhesive is divided into the following types.

a) Type 1. gum type.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

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