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YY/T 1886-2023 English PDF

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YY/T 1886-2023: Forest certification in China - Audit directive on bamboo management certification
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YY/T 1886-2023English589 Add to Cart 5 days [Need to translate] Forest certification in China - Audit directive on bamboo management certification Valid YY/T 1886-2023

PDF similar to YY/T 1886-2023


Standard similar to YY/T 1886-2023

LY/T 2407   GB/T 30762   

Basic data

Standard ID YY/T 1886-2023 (YY/T1886-2023)
Description (Translated English) Forest certification in China - Audit directive on bamboo management certification
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard B64
Classification of International Standard 11.060.10
Word Count Estimation 28,286
Date of Issue 2023-01-13
Date of Implementation 2024-01-15
Issuing agency(ies) State Drug Administration
Summary This standard 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 an amount suitable for making a single dental filling; Performance requirements and test methods for dental silver alloy powders and capsules and silver amalgam, as well as requirements for packaging and labeling. This standard applies to dental amalgam products labeled "pre-filled capsules". This standard does not apply to free-flowing silver alloy powder and silver alloy powder in tablets in bulk form, nor does it apply to mercury packets and bulk mercury. This standard does not apply to metal materials used to make dental restorations that use metal alloy powders and liquid alloys to react at ambient temperature to form solid metal materials. This standard does not contain qualitative and quantitative requirements for possible biological hazards

YY/T 1886-2023: Forest certification in China - Audit directive on bamboo management certification


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ICS 11.060.10 CCSC33 Pharmaceutical Industry Standard of the People's Republic of China Dental Amalgam in Capsules (ISO 20749.2017, MOD) Released on 2023-01-13 2024-01-15 Implementation Released by the State Drug Administration

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" drafting. This document is modified to adopt ISO 20749.2017 "Silver Amalgam in Capsules in Dentistry". The technical differences between this document and ISO 20749.2017 and their reasons are as follows. ---In "Properties of dental amalgam", change "1h minimum compressive strength 100MPa" to "1h minimum compressive strength 80MPa" (see 4.7), to adapt to the actual situation of existing products in our country; ---In "Mass loss of capsules during blending" put "average mass loss of dental mercury and dental silver alloy powder in 15 capsules (mixed according to manufacturer's instructions) not to exceed 0.5 mg" changed to "dental mercury and dental silver alloy in 5 capsules The average mass loss of the powder (reconciled according to the manufacturer's instructions) shall not exceed 0.5 mg" (see 4.4) to better protect The environment and the health of testing personnel. Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee on Dental Materials and Devices (SAC/TC99). This document is drafted by. Peking University School of Stomatology Dental Medical Device Inspection Center, Shanghai Medical Devices Co., Ltd. Dental Materials Material factory. The main drafters of this document. Yuan Shenpo, Lin Hong, Sun Zhihui, Du Zumin, Bai Wei, Zhang Dianyun.

Introduction

This document applies only to dental silver alloy powder and dental mercury in capsules of a certain quality, dental silver alloy powder and dental mercury in individual capsules. Dental amalgam prepared with Komermal is sufficient for the restoration of individual small or medium-sized restorations of individual teeth. Dental silver alloy powder and dental mercury are essential components of dental amalgam restorative materials. This document has been prepared in accordance with the United Nations Environment Programme's Minamata Convention on Mercury. The objective of the Minamata Convention on Mercury is to adopt Reduce anthropogenic mercury pollution by restricting the use of mercury, mercury-containing products, and materials that release mercury during use. In this convention, dental amalgamation Gold is classified as a "mercury-added product", for which the parties to the agreement should take two or more measures from List IX. One of them is "Dental Silver Amalgam restricted to use in encapsulated form". In some countries, the term "encapsulated" is interpreted only as pre-encapsulated form. Since the signing of the Minamata Convention on Mercury in Countries that allow the use of prepackaged products are able to adopt standards for dental amalgam. Although this document is formulated based on YY/T 1026, major technical requirements have been changed. In addition, YY 0715 middle rubber The requirements of the package are also incorporated into this document, and the products to which this document applies are considered as a whole. This document and the specific technical requirements of YY/T 1026 Change as follows. --- This document is only applicable to pre-capsulated dental amalgam products. --- This document makes requirements for the pollution-free capsules and packaging. --- This document deletes the requirements for foreign matter in dental silver alloy powder. --- This document increases the requirements for the mass loss of capsules during the blending process. --- This document replaces the requirements for the quality of dental mercury and silver alloy powder before blending with the requirements for the output of amalgam in capsules. --- This document has fundamentally changed the requirements for consistency in the ratio of dental mercury to silver alloy powder in capsules. changed to Determination of the effect of changes in this ratio on performance is used instead of weighing mercury and silver alloy powders. --- This document introduces the requirements for capsules and makes technical revisions to it. This document makes no changes to the requirements not related to packaging, which are. --- Chemical composition and purity requirements of silver alloy powder; --- Properties of amalgam; ---The properties of silver amalgam after mixing and before curing. Like YY/T 1026, this document takes corrosion resistance requirements into consideration. However, there is consensus that the available data are not sufficient for this paper Corrosion resistance requirements are set in this version of the component. Requirements for corrosion resistance will be developed and incorporated at the earliest possible date. It is recommended to evaluate dental Refer to YY/T 0515 for the corrosion resistance of silver amalgam products. Dental Amalgam in Capsules

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. 3.1 dental silver alloy powder dentalamalgamaloy Fine powder, mainly composed of silver, tin and copper, mixed with dental mercury (3.2) to form dental amalgam.

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