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YY 1027-2018Dentistry—Hydrocolloid impression materials (English PDF)

牙科学水胶体印模材料

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

June 14, 2018

Implementation date

July 1, 2019

Scope

YY 1027-2018 is the English-translated version of 牙科学水胶体印模材料.

YY 1027-2018 is the Chinese standard "Dentistry—Hydrocolloid impression materials". Its scope clause reads: This standard specifies the performance requirements and test methods for elastic aqueous agar and alginate hydrocolloid dental impression materials in order to determine their ability Whether the expected quality of use is achieved.

At the same time, the requirements for the instruction manual and label are specified. This standard applies to elastic aqueous agar and alginate hydrocolloid dental impression materials.

Note. This standard does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended to evaluate the potential biological hazards of hydrocolloid impression materials. Refer to ISO 10993 and ISO 7405. Its clauses include terms and definitions.

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Document preview — YY 1027-2018

National Standard of the People's Republic of China

ICS: 11.060.10
Classification: C 33
Replacing: YY 1027-2001, YY 0494-2004

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

Foreword
1 Scope
2 Normative references
3 Terms and Definitions
4 Classification of agar water colloid impression materials
5 Requirements---Features and Performance
6 pre-test treatment
7 Test method
8 Labels and Instructions for Use
Appendix A (Normative Appendix) Schematic diagram of equipment and accessories for testing
Appendix B (informative) Preparation of an optional sample holding method for the tear resistance test

1 Scope

This standard specifies the performance requirements and test methods for elastic aqueous agar and alginate hydrocolloid dental impression materials in order to determine their ability

Whether the expected quality of use is achieved. At the same time, the requirements for the instruction manual and label are specified.

This standard applies to elastic aqueous agar and alginate hydrocolloid dental impression materials.

Refer to ISO 10993 and ISO 7405.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.

Pieces. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696.1987, MOD)

GB/T 9937.1-2008 Oral vocabulary Part 1. Basic and clinical terms (ISO 1942-1.1989, IDT)

GB/T 9937.2-2008 Oral vocabulary Part 2. Oral materials (ISO 1942-2.1989, IDT)

GB/T 9937.3-2008 Oral vocabulary Part 3. Oral devices (ISO 1942-3.1989, IDT)

GB/T 9937.4-2005 Dental terminology - Part 4. Dental equipment (ISO 1942-4.1989, IDT)

GB/T 9937.5-2008 Oral vocabulary Part 5. Terminology related to testing (ISO 1942-5.1989, IDT)

YY 0462-2018 Dental Gypsum Products (ISO 6873.2013, MOD)

3 Terms and definitions

GB/T 9937.1-2008, GB/T 9937.2-2008, GB/T 9937.3-2008, GB/T 9937.4-2005, GB/T 9937.5-

The following terms and definitions defined in.2008 apply to this document.

3.1 Bonding

The viscous properties of the reversible and irreversible stamp components in the impression material, resulting in the formation of individual components that require separate interactions

A uniform impression system to achieve the desired elasticity and effective impression, and can be successfully removed from the mouth.

3.2 Large packaging container

Labeled sales or direct packaging containers containing bulk granules, liquids, powders or other loose materials, usually in packs

The amount required for more than one oral clinical treatment or laboratory operation.

3.3 Reversible/irreversible impression material bonding system

The low consistency agar material is first injected around the selected tooth and can be passed through the irreversible alginate impression material during impression molding.

An impression system that is used under pressure bonding.

3.4 Sales package

A unit of sale that contains the package and its contents at the time of retail sale to the end user or consumer.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 38 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 9937.1-2008 · GB/T 9937.3-2008 · GB/T 9937.4-2005

Similar standards

YY/T 0493-2022|YY/T 1818-2022|YY 0710-2025|YY 0717-2023|YY 1042-2023|YY 0714.2-2016

Editions of YY 1027

Edition	Title	Revision	Status
YY 1027-2018	Dentistry—Hydrocolloid impression materials	current edition	Current
YY 1027-2001	Dentistry—Hydrocolloid impression materials	previous edition	Superseded

This page sells the current edition, YY 1027-2018. Earlier editions are listed for reference only.

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