YY/T 0624-2016Dentistry-Elastomeric auxiliaries 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 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) A resilient, interconnected elastic or porous elastic band attached to the tooth.

--- 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)

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 document. 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.