YY/T 0625-2016Dentistry—Wires for use in orthodontics (English PDF)

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 °C" requirements, Changed to "austenite transition end temperature should be accurate to 1 °C".

--- 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).

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 document. 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.