YY/T 1886-2023Dentistry - Pre-capsulated dental amalgam (English PDF)

1 Scope

This document specifies the performance requirements and test methods for amalgam products in capsules, which contain a certain proportion of dental silver alloy powder and

Dental mercury in quantities suitable for making individual dental fillings; specifies dental silver alloy powders and capsules and silver

The performance requirements and test methods of amalgam also specify the requirements for packaging and labeling.

This document applies to dental amalgam products labeled "pre-filled capsules".

This document does not apply to free-flowing silver alloy powder and tablet silver alloy powder in bulk form, nor does it apply to mercury packets and bulk mercury.

This document does not apply to the use of metal alloy powders and liquid alloys to react at ambient temperature to produce solid metal materials for the manufacture of dental restorations.

complex metal material.

This document does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that when evaluating possible biological hazards, refer to

GB/T 16886.1 and YY/T 0268.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references

Only the version corresponding to that date applies to this document. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 1800.2 Product Geometric Specifications (GPS) Linear Dimensional Tolerances ISO Code System Part 2.Standard Tolerance Zones

Code and limit deviation table of holes and shafts (GB/T 1800.2-2020, ISO 286-2.2010, MOD)

GB/T 2893.2 Graphical symbols, safety colors and safety signs - Part 2.Design principles for product safety labels (GB/T 2893.2-2020, ISO 3864-2.2016, MOD)

GB/T 6003.1 Test sieve technical requirements and inspection Part 1.Wire mesh test sieve (GB/T 6003.1-

2012, ISO 3310-1.2000, MOD)

GB/T 9258.1 Particle size analysis of abrasives for coated abrasives Part 1.Particle size composition (GB/T 9258.1-2000,

ISO 6344-1.1998, IDT)

GB/T 9937 Terminology in Dentistry (GB/T 9937-2020, ISO 1942.2009, MOD)

GB/T 18778.2 Product Geometric Quantity Specifications (GPS) Surface Structure Profile Method Surfaces with Composite Machining Features No. 2

Part. Characterization of Height Characteristics by Linearized Support Ratio Curve (GB/T 18778.2-2003, ISO 13565-2.1996, IDT)

YY/T 0466.1-2016 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1.General Requirements

Seek (YY/T 0466.1-2016, ISO 15223-1.2012, IDT)

ISO 7488 Dental amalgamators (Dentalamalgamators)

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