YY/T 1026-2019Dentistry—Dental amalgam (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 1026-2009 "dental mercury and silver alloy powder", compared with YY 1026-2009, except editorial changes The main technical changes are as follows.

--- Modify the standard name to indicate the content and requirements contained in the standard.

--- This standard no longer applies to bulk packaging of dental mercury (bulk mercury). By limiting the supply of dental mercury to meet the requirements of this standard, Often concerned with the environmental impact of the sale of large packages of mercury (applied) is limited.

---Because the large package of dental mercury has been removed from the scope of this standard, oil, water and impurity particles have been removed accordingly.

Pollution of mercury and purity of mercury - two requirements of the free flow method.

--- Revised the dimensional change during hardening and the required value of 24h minimum compressive strength. Dimensional change during hardening The allowable value is changed from -0.10% to 0.20% to -0.10% to 0.15%. 24h minimum compressive strength increased from 300MPa To 350MPa.

--- The regulations for marking and packaging have been revised.

--- Safety warnings and precautions for mercury on external packaging have been revised to meet ISO and GHS requirements. Seeking no longer related to national and regional requirements.

--- This standard removes the corrosion test method specified in the normative appendix. The corrosion test method is included in a new international technical specification.

Fan ISO /T S17988. Dentistry---Test method for corrosion resistance of dental amalgam.

This standard uses the redrafting method to modify the use of ISO 24234:2015 "dental dental amalgam".

The technical differences between this standard and ISO 24234:2015 and their reasons are as follows.

---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments The situation is reflected in Chapter 2, "Regulatory Citations", and the specific adjustments are as follows.

- Replace ISO 3864-2 with GB/T 2893.2 modified to international standards (see 7.2.2);

- Replace ISO 3310-1 with GB/T 6003.1 modified to international standards (see 6.2);

- Replace ISO 6344-1 with GB/T 9258.1 equivalent to the international standard (see 6.5.1, 6.6.2, 6.7.1);

- Replace ISO 1942 with GB/T 9937-2008 equivalent to international standards (see Chapter 3);

- Replace ISO 13565-2 with GB/T 18778.2 equivalent to the international standard (see 6.4.3.2);

- Replace ISO 15223-1 with YY/T 0466.1, which is equivalent to the international standard (see 7.2.2);

- Replace ISO 13897 with YY 0715, which is equivalent to the international standard (see 6.2, 6.4.2, 7.1, 7.2.1, 7.3.1).

---1h minimum compressive strength changed from 100MPa to 80MPa to adapt to the actual situation of existing products in China.

Introduction

Dental silver alloys and dental mercury are the most basic and only two components of dental amalgam restorations. This standard specifies dental Requirements and test methods for silver amalgam alloys (including dental mercury), including requirements and test methods for amalgam after curing, and Packaging labeling requirements.

This standard does not contain qualitative and quantitative requirements for possible biological hazards, but is recommended for evaluation of possible biological hazards.

YY/T 0268 "Clinical Evaluation of Dental Biomedical Devices, Unit 1. Evaluation and Testing".

To enhance the safety protection of dentists and related service personnel, which may result from accidental damage to the packaging during transportation.

Minimize the hazard and impose separate restrictions on the form of dental mercury to be supplied in the form of pre-filled capsules or mercury packs. And limit it The amount of a single package is enough to reconcile once.

This release enhances security alerts related to packaging, labeling and labeling.

A suitable specification for amalgams using silver alloys (eg, high copper-silver alloys) with a copper content (mass fraction) of more than 12% has been considered.

Wai, because there are reports that, in general, the use of high-silver-silver alloy amalgam is more than a traditional silver alloy (low copper-silver alloy).

The resulting restoration has a better long-term preservation rate. However, since some restorations made of low-copper silver alloy have been used with high-copper silver After the gold-made restoration was as durable, this view was denied. In addition, the product should not be changed due to changes in product composition.

The standard requirements become non-conformance, and should be judged based on whether or not they meet the requirements of the indicators that determine their performance.

When this standard is formulated, it is considered that the requirements for corrosion resistance should be included, but the available data is not sufficient to set the requirements for corrosion resistance.

Therefore, the corrosive requirements will be established as early as possible and given as part of the standard. Recommended for amalgam products Refer to ISO /T S17988 for evaluation of the corrosion resistance of other amalgam-related products.

In the first edition of this standard (including the previous ISO 1559), the compression strength of dental amalgam was determined using compressive strength.

Degree test method. In this version, the compression strength test method and compression strength requirements are still used. However, the working group recognized that the teeth Branch silver amalgam is actually a brittle material and should be determined by a suitable test procedure in a way that can simulate clinical applications.

The tensile stress of the fracture. The work done now is not enough to include this test method (including requirements) in this version of the standard. In evaluation At the end, an opinion will be given to increase the use of this method to test the breaking strength. Eventually a technical revision was formed.

1 Scope

This standard specifies the requirements, sampling, test methods, packaging, marking and manufacturer of silver amalgam alloys (including dental mercury). Book.

This standard applies to bulk silver alloys, tablet silver alloys and capsule silver alloys (eg pre-filled capsules).

This standard applies to silver alloys or mercury supplied separately. For dental mercury, it is limited to mercury supplied in mercury or pre-packaged form.

The quality of mercury supplied in both forms is also limited to sufficient and only enough to reconcile once. The quality of dental mercury in a capsule or a mercury pack should be sufficient A homogeneous plastic body is produced, which can be used for a small or medium-sized restoration of a single tooth. This standard does not apply to a single original Mercury in the package that is greater than the above requirements (eg bulk dental mercury). Bulk dental mercury does not meet this standard.

This standard does not apply to the use of metal alloy powders and liquid alloys to cure at ambient temperature to produce dental restorations. material.

Note. Dental mercury should be no less than 99.99% pure, so it is a metal element of high industrial purity, not an alloy.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 2893.2 Graphical symbols - Safety colours and safety signs - Part 2. Design principles for product safety labels (GB/T 2893.2- 2008, ISO 3864-2:2004, MOD)

GB/T 6003.1 Test sieves - Technical requirements and testing - Part 1. Wire woven mesh test sieves (GB/T 6003.1-2012,

ISO 3310-1:2000, MOD)

GB/T 9258.1 Abrasives for coated abrasives - Part 1. Granular composition (GB/T 9258.1-2000,

ISO 6344-1:1998, IDT)

GB/T 9937 oral vocabulary [GB/T 9937-2008 (all parts), ISO 1942. 1989, IDT]

GB/T 18778.2 Geometrical Product Specifications (GPS) Surface structure profile method with composite machining features Part 2. Characterization of height characteristics using linearized support rate curves (GB/T 18778.2-2003, ISO 13565-2:1996, IDT)

YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)

YY 0715 Dental Science Amalgam Capsules (YY 0715-2009, ISO 13897:2003, IDT)

ISO 286-2 Geometrical Product Specifications (GPS) ISO Linear Dimensional Tolerance Code System Part 2. Standards for Holes and Shafts Tolerance level and limit deviation table

ISO 7488 dental amalgamator

3 Terms and definitions

The following terms and definitions as defined in GB/T 9937 apply to this document.