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YY 0493-2011Dentistry—Elastomeric impression materials (English PDF)

牙科学 弹性体印模材料

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY 0493-2011 is the English-translated version of 牙科学 弹性体印模材料.

YY 0493-2011 is the Chinese standard "Dentistry—Elastomeric impression materials". Its scope clause reads: This standard specifies requirements for characteristics and properties and test methods for evaluating elastomeric dental impression materials.

Its clauses include terms and definitions; classification; biocompatibility advisory; requirements for characteristics and properties.

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Document preview — YY 0493-2011

National Standard of the People's Republic of China

Replacing
YY 0493-2004

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

Contents

  • Foreword II
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 Classification
  • 5 Biocompatibility advisory
  • 6 Requirements for characteristics and properties
  • 6.1 Component colours
  • 6.2 Mixing time (hand-spatulated or hand-kneaded mixtures)
  • 6.3 Working time (Types 1, 2 and 3 only)
  • 6.4 Consistency
  • 6.5 Detail reproduction
  • 6.6 Linear dimensional change
  • 6.7 Compatibility with gypsum
  • 6.8 Elastic recovery
  • 6.9 Strain-in-compression
  • 7 Sampling
  • 8 Test methods - General
  • 8.1 Laboratory conditions
  • 8.2 Apparatus function verification
  • 8.3 Material manipulation and specimen preparation
  • 8.4 Pass/fail determinations
  • 8.5 Expression of test results
  • 9 Test methods - Specific
  • 9.1 Mixing-time test
  • 9.2 Consistency test
  • 9.3 Working-time test
  • 9.4 Detail reproduction test
  • 9.5 Linear dimensional change test
  • 9.6 Test for compatibility with gypsum
  • 9.7 Elastic recovery test
  • 9.8 Strain-in-compression test
  • 10 Requirements for information in manufacturer's instructions
  • 10.1 General
  • 10.2 Identifying information
  • 10.3 Instructions for use
  • 11 Requirements for packaging and labelling
  • 11.1 Packaging requirements
  • 11.2 Labelling requirements
  • Annex A (Informative) Working-time test apparatus components - Possible sources
  • Bibliography
  • Forew
  • .detail td {

1 Scope

This standard specifies requirements for characteristics and properties and test methods for evaluating elastomeric dental impression materials.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 1942 Dentistry - Vocabulary

ISO 6873:1998 Dental gypsum products

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.

3.1 consistency

degree of firmness with which particles of a material, prepared for use, cohere so as to allow the material to flow, or resist flow, as required to achieve the purpose for which it is intended

3.2 elastic recovery test

(elastic impression materials) method of determining whether the materials possess the elastic properties required to recover adequately after deformation occurring when the materials, used for forming impressions, are removed from the mouth

Note: The terms "compression set", "permanent deformation", and "recovery from deformation" are deprecated here.

3.3 extrusion mixing

method by which two or more material components are extruded from their separate immediate containers through a special mixing tip, from which the components emerge as a homogeneous mixture

3.4 hand mixing

method of mixing the components of a material by means of manual kneading or spatulation

3.5 immediate container

container which is in direct contact with a material or a component thereof

Note: An immediate container may be an unlabelled container protected by a more durable labelled outer package component such as a can, carton or drum. If it is strong enough to protect its contents without outer package, an immediate container can also serve as a primary container on which labelling shall be required.

3.6 mixing time

time, measured from first contact between different components of a material being mixed, required to achieve a homogeneous mixture when the components are mixed according to the manufacturer’s instructions

Note: The time of first contact between extrusion-mixed material components is defined as the time when the material components can be seen entering into the mixing nozzle.

3.7 outer package

wrapping or carton, which may be required by law or a standard to bear specified labelling, used to cover one or more immediate or primary containers in preparation for retail marketing

3.8 primary container

retail marketing packaging component, such as a bottle, carton, drum, jar, and tube, which may be required by law or a standard to bear specified labelling

Note: A primary container may also be an immediate container.

3.9 strain-in-compression test

(elastic impression materials) method of measuring the flexibility/stiffness property ranges of materials so as to determine whether the set materials, when formed as impressions a) can be removed from the mouth without injury to impressed oral tissues, and b) will have adequate stiffness, in the more flexible portions of impressions, to resist deformation when model-forming products are poured against them

3.10 working time

period of time, beginning with the commencement of mixing and ending before the material being mixed has begun to exhibit elastic properties that will prevent the material from being manipulated as required to form an impression or a mould having the desired surface detail and dimensional characteristics

4 Classification

Materials are classified according to consistencies determined immediately after completion of mixing according to the manufacturer’s instructions (10.3):

——Type 0: Putty consistency;

——Type 1: Heavy-bodied consistency;

——Type 2: Medium-bodied consistency;

——Type 3: Light-bodied consistency.

5 Biocompatibility advisory

Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this standard. It is recommended that, in assessing possible biological or toxicological hazards, reference be made to YY/T 0268 and GB/T 16886.1 (see Bibliography).

6 Requirements for characteristics and properties

6.1 Component colours

Different components intended for use in the same mixture shall be supplied in contrasting colours to provide a means of determining when the components have been thoroughly mixed.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 26 pages — is available in the English PDF.

Similar standards

Editions of YY 0493

EditionTitleRevisionStatus
YY 0493-2011Dentistry—Elastomeric impression materialscurrent editionCurrent
YY 0493-2004Dentistry—Elastomeric impression materialsprevious editionSuperseded

This page sells the current edition, YY 0493-2011. Earlier editions are listed for reference only.

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