YY/T 0624-2016 English PDF

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YY/T 0624-2016: Dentistry--Elastomeric auxiliaries for use in orthodontics
Status: Valid

YY/T 0624: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0624-2016	184	Add to Cart	3 days	Dentistry--Elastomeric auxiliaries for use in orthodontics	Valid
YY 0624-2008	279	Add to Cart	3 days	Dentistry. Orthodontic products. Orthodontic elastomeric auxiliaries	Obsolete

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Basic data

Standard ID: YY/T 0624-2016 (YY/T0624-2016)
Description (Translated English): Dentistry--Elastomeric auxiliaries 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: 10,171
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Older Standard (superseded by this standard): YY 0624-2008
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 0624-2016: Dentistry--Elastomeric auxiliaries 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 - Elastomeric auxiliaries for use in orthodontics ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0624-2008 Dental Orthodontic Elastomer Attachment (ISO 21606..2007, IDT) 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 0624-2008 "Orthodontic elastomer accessories for dental orthodontic products". Compared with YY 0624-2008, the main technical changes of this standard are as follows. --- Standard name changed from "orthodontic orthodontic elastomer annex" to "dental orthodontic elastomer attachment". --- Added normative reference documents. - Terminology and definition of the removal of elastomers and orthodontic elastic tubes; increased pitch, test length, initial deformation tensile force, 24h residual The definition of the tensile and tensile limits. --- Added 4.1 General requirements. --- 4.2 size and 4.3 mechanical performance requirements no longer limit the detection value should be consistent with the percentage of the manufacturer's specified value, but directly Foot. "should be within the scope of the production plant." --- remove the YY 0624-2008 4.3 appearance requirements. --- Deleted 4.4 Biocompatibility requirements in YY 0624-2008, only in the ISO introduction. "This standard does not contain the relevant production Qualitative and quantitative requirements for biology hazards, but recommended in the evaluation of possible biological hazards, see GB/T 16886.1 "Biological evaluation of medical devices Part 1. Evaluation and testing in risk management" and YY/T 0268 "Dentistry Oral Medical Device Biology Evaluation Unit 1. Evaluation and Test ". " --- According to ISO 21606..2007, the initial deformation tensile force, 24 hours residual tensile force, the tensile limit of the test steps. - In accordance with ISO 21606..2007, Chapter 7 "Marking, Labeling and Packaging" was redrafted. --- Added reference. This standard uses the translation method equivalent to ISO 21606..2007 "dental orthodontic elastomer attachment". And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows. GB/T 6682-2008 Analytical laboratory water specifications and test methods (ISO 3696. 1987, MOD) --- GB/T 7408-2005 Data element and exchange format Information exchange date and time representation (ISO 8601..2000, IDT) --- GB/T 9937 (all parts) Oral vocabulary (all parts) (ISO 1942, IDT) 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 main drafting unit of this standard. the State Food and Drug Administration Beida Medical Device Quality Supervision and Inspection Center, Minnesota Mining System (Shanghai) International Trade Co., Ltd., Beijing Medical Device Testing Institute. The main drafters of this standard. Zheng Gang, Li Yuan, Han Jie, Shen Danlin, Zhang Zhengpu, Sun Zhihui. This standard replaced the previous version of the standard release. --- YY 0624-2008.

Introduction

Difficult to orthodox elastomer accessories for effective comparison and development. This standard does not contain qualitative and quantitative requirements for the biological hazards of the product, but it is recommended that in assessing possible biological hazards, see GB/T 16886.1 "Biological evaluation of medical devices Part 1. Evaluation and testing in risk management" and YY/T 0268 "Dentistry Biology Evaluation of Oral Medical Devices Part 1. Evaluation and Testing ". Dental Orthodontic Elastomer Attachment

1 Scope

This standard applies to all orthodontic elastomeric attachments which, in the mouth or outside the mouth, cooperate with a fixed or active appliance for orthodontic treatment use. Elastic accessories include. orthodontic elastic traction ring, elastic band, rubber chain, elastic ring, elastic line and ligation ring and so on.

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 3696. 1987 Analysis of laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specifica- tionandtestmethods) ISO 8601 data element and exchange format information exchange date and time representation (Dataelementsandinterchange formats-informationinterchange-Representationofdatesandtimes)

3 terms and definitions

ISO 1942 (all parts) and the following terms and definitions apply to this document. 3.1 Orthodontic elastic traction To force the mouth of the mouth and the mouth of the elastic ring. 3.2 Orthodontic line of orthodonticthread An elastic line (which may be hollow) with a constant cross section. 3.3 Orthodontic elastic rubber chain orthodonticelastomericchain A resilient, interconnected elastic or porous elastic band attached to the tooth. 3.4 Orthodontic elasticity ligation An annular elastomer for fixing the orthodontic wire to the orthodontic device. 3.5 Orthodontic elasticity of the teeth An elastic ring for expanding the gap between adjacent teeth. 3.6 Circle distance linklength The distance between the center of the two rings of the orthodontic elastic rubber chain. see picture 1. ......

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