YY/T 0915-2015 English PDF

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YY/T 0915-2015: Dentistry. Brackets and tubes for use in orthodontics
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0915-2015	254	Add to Cart	3 days	Dentistry. Brackets and tubes for use in orthodontics	Valid

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Basic data

Standard ID: YY/T 0915-2015 (YY/T0915-2015)
Description (Translated English): Dentistry. Brackets and tubes 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: 13,158
Date of Issue: 2015-03-02
Date of Implementation: 2016-01-01
Quoted Standard: ISO 1942-2009
Adopted Standard: ISO 27020-2010, IDT
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to pipes fixed orthodontic appliance in the brackets and buccal. This Standard specifies the comparison orthodontic brackets and buccal tubes of functional size measurement methods and test method details, and product packaging and labeling information provisions. This Standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards, the reference ISO 10993-1 and 1SO 7405.

YY/T 0915-2015: Dentistry. Brackets and tubes 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.Brackets and tubes for use in orthodontics ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standard Orthodontic brackets and buccal tubes (ISO 27020.2010, IDT) Released on.2015-03-02 2016-01-01 implementation State Food and Drug Administration issued

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the translation method equivalent to ISO 27020.2010 "dental orthodontic brackets and buccal tubes". The documents of our country that have a consistent correspondence with the international documents referenced in this standard are as follows. ---GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)] Please note that some elements of this standard may involve patents. The issuing body of this standard shall not be responsible for identifying these patents. This standard was proposed by the State Food and Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Devices (SAC/TC99). This standard was drafted. State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center, Minnesota Mining Manufacturing (Shanghai) International Trade Co., Ltd., Hangzhou Xinya Dental Materials Co., Ltd. The main drafters of this standard. Zheng Gang, Bai Wei, Han Jie, Zhang Zhengpu, Chen Xianming, Lin Quanhong, Sun Zhihui.

Introduction

Because clinicians often encounter difficulties when comparing orthodontic brackets to buccal tubes using information provided by existing manufacturers, Develop this standard. Orthodontic brackets and buccal tubes

1 Scope

This standard applies to brackets and buccal tubes in orthodontic fixed appliances. This standard specifies the functionality of orthodontic brackets and buccal tubes. The method of size and the details of the test method are specified, and the packaging and labeling information of the product is specified. This standard does not contain qualitative and quantitative requirements for possible biological hazards, but is recommended for evaluation of possible biological hazards. ISO 10993-1 and ISO 7405.

2 Normative references

The following documents are indispensable for the application of this standard. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. ISO 1942 (all parts) Oral vocabulary (Dentistry-Vocabulary)

3 Terms and definitions

The following terms and definitions defined by ISO 1942 apply to this document. 3.1 Torque angle angleoftorque Observed along the long-axis direction of the groove (hole), the torque angle is the point of intersection of the groove (hole) jaw to the intersection of the mid-perpendicular line and the flank surface. The perpendicular line of the tangential basal plane at this point is at an angle to the vertical line of the groove (hole) of the jaw. Note. If this angle is toward the jaw (龈), it is positive (negative). see picture 1. 3.2 Axis inclination angulation Viewed along the cheek, formed by a perpendicular perpendicular to the long axis of the groove (hole) and the jaw line of the bracket/bucket tube intersecting the central axis Angle. Note. This angle is positive (negative) when the jaw is oriented toward the far (near) end of the central axis intersecting the perpendicular perpendicular to the groove (hole). See Figure 2. 3.3 Archwire archwire An orthodontic wire that approximates the shape of the arch. 3.4 Auxiliary bow groove (hole) auxiliaryslot A groove (hole) that is additionally opened on the bracket or buccal tube for inserting the attachment. 3.5 Auxiliary bow groove (hole) size auxiliaryslotdimensions The diameter or representative size of the largest archwire that can pass through the arch (hole). ......

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