YY/T 0625-2016 English PDF

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YY/T 0625-2016: Dentistry--Wires for use in orthodontics
Status: Valid

YY/T 0625: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0625-2016	239	Add to Cart	3 days	Dentistry--Wires for use in orthodontics	Valid
YY 0625-2008	319	Add to Cart	3 days	Dentistry. Orthodontic Products: Wires	Obsolete

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Basic data

Standard ID: YY/T 0625-2016 (YY/T0625-2016)
Description (Translated English): Dentistry--Wires for use in orthodontics
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 12,167
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Older Standard (superseded by this standard): YY 0625-2008
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration

YY/T 0625-2016: Dentistry--Wires for use in orthodontics

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Dentistry - Wires for use in orthodontics ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0625-2008 Dental Orthodontics (ISO 15841..2006, MOD) 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0625-2008 "orthodontic products. orthodontic silk", compared with YY 0625-2008, the main technical changes as follows. --- 3.2 in the definition of bending stiffness, the "dimension of MPa". Change to "unit is N/mm". --- To the size of 5.2, the "cross-sectional size should be marked in the size of ± 0.01mm" requirements, with "cross-sectional size should be accurate to 0.01mm ". --- 5.3 Austenite transition in the end of the temperature, the "austenite transition temperature range should be marked to ± 1 ℃" requirements, Changed to "austenite transition end temperature should be accurate to 1 ℃". --- cancel the 5.4 mechanical properties, all on the "measurement accuracy of 1%" requirements. --- In Section 5.4.2, the "permanent flexural deformation rate" is changed to "permanent flexural deformation". - In the 6.4.1 tensile test, the "elastic modulus is determined by measuring the slope of the stress-strain curve straight line segment" with "6.4.2.3.6 The modulus of elasticity is determined by measuring the slope of the force-displacement curve straight line segment. This standard is the main difference between ISO 15841..2006 and ISO 15841..2006 for the revision of the ISO 15841..2006 Dental Orthodontic Wire standard. --- modify Figure 1. --- increase the type of orthodontic bending stiffness curve of the diagram, "Figure 4 bending stiffness curve", and the back of the drawing number extension. --- Modify Figure 4 Bend test curve. --- will be 7.3, "g) for nickel, beryllium products, should contain a warning symbol (including the exclamation point of the triangle) and warning text. 'the The product contains nickel. 'And/or' this product contains beryllium. '. "Changed to." g) There should be a warning to the harmful elements contained in the product The appropriate place should be symbolic way). " And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows. GB/T 228.1-2010 Metallic materials - Tensile testing - Part 1. Room temperature test method (ISO 6892-1..2009, MOD). GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts), IDT]. This document is as follows. (1) The documents of this paper are as follows. GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1..2009, IDT). - YY/T 0268-2008 Dental Oral Medical Device Biological Evaluation Unit 1. Evaluation and Test (ISO /FDIS 7405-2008, NEQ). Please note that some of the contents of this document may involve patents. The issuer of this document shall not be responsible for the identification of such patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99). The drafting of this standard. the State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center, the research and development of new materials shares Co., Ltd., Minnesota Mining Manufacturing (Shanghai) International Trade Co., Ltd., Beijing St. Matt Technology Co., Ltd. The main drafters of this standard. Zheng Gang, Bai Wei, Miao Weidong, Han Jie, Huang Bingmin, Sun Zhihui, Yuan Shenpo. This standard replaced the previous version of the standard release. --- YY 0625-2008.

Introduction

It is difficult to effectively compare the development of orthodontic silk. Dental Orthodontics

1 Scope

This standard specifies the requirements and test methods for the production of orthodontic fibers for fixed and removable orthodontic appliances. This standard applies to preforming Of the orthodontic arch wire, this standard does not apply to springs and other preforms. This standard specifies the physical and mechanical properties of the distorted silk, as well as the corresponding requirements for the corresponding test methods, packaging and identification information. This standard does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended that in assessing possible biological hazards, See ISO 7405 and ISO 10993-1.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. ISO 1942 (all parts) oral vocabulary (Dentistry-Vocabulary) ISO 6892 Metallic materials at room temperature tensile test method (Metalicmaterials-Tensiletestatatambienttemper- ature

3 terms and definitions

ISO 1942 (all parts) and the following terms and definitions apply to this document. 3.1 Austenite - finishtemperature Taf The temperature at which the alloy is converted from the low temperature martensite to the high temperature austenite phase. 3.2 Bending stiffness Sb Increase the load value required for the unit deflection in N/mm (for example, in the case where the deflection of the bending test is proportional to the load, Bending test). 3.3 Descriptor descriptor According to the accepted orthodontic convention, the identification code for the nominal cross-sectional size of the orthodontic silk, expressed as a thousandth of an inch without unit name (For example, 16, 18, 17 x 25, 21 x 21). 3.4 Diagonal diagonal Square wire maximum cross - sectional size. see picture 1. ......

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