YY 0622-2008Dental resin-based pit and fissure sealants (English PDF)
牙科树脂基窝沟封闭剂
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
April 25, 2008
Implementation date
December 1, 2009
Scope
YY 0622-2008 is the English-translated version of 牙科树脂基窝沟封闭剂.
YY 0622-2008 is the Chinese pharmaceutical industry standard for the dental resin-based pit and fissure sealant, the material with which the fissures of a tooth are closed against decay.
It specifies the performance requirements and the test methods for sealants cured chemically and for those cured by an external energy source, covering the working and setting time, the depth of cure, the flow and the film thickness, the water sorption and solubility, the colour stability and the radiopacity where claimed, and the information supplied with the material. Issued on 25 April 2008, it has applied since 1 December 2009.
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Document preview — YY 0622-2008
National Standard of the People's Republic of China
- ICS
- 11.060.10
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 4 Requirements
Foreword
All technical contents of this standard is mandatory.
This standard is identical with ISO 6874. 1988 "dental resin-based pit and fissure sealants." And ISO 6874. 1988 have been included technical differences Into the body, and they are involved in terms of the margin of a single vertical line identification.
This standard is based on ISO 6874. 1988 re-drafted. This standard and ISO 6874. 1988 The main differences are as follows.
--- Normative references cancel ISO 2014. 1976;
--- "4.4.7 biocompatible" to refer to the appropriate standard of YY/T 0268;
--- 8.2.1 package will "c) sealant main chemical ingredient"; contained drugs and "e) material specification and claims referred to the use of Active ingredient "; move to the manufacturer's instructions and information 8.3 in g) and h);
--- 8.3 the manufacturer's instructions and information added to 1) if the patient indicates the product of some kind of allergy, this product should be used with caution.
Introduction
Prevention of dental caries by pit and fissure sealants effectiveness is now widely accepted. Resin-based material after radical polymerization can prevent pit and fissure tooth Point gap at the formation of dental caries.
This standard does not contain information about product hazards biology qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards, please see
1 Scope
This standard specifies performance requirements and test methods for closing the teeth fissure point gap resin-based material.
This standard applies to chemical and cured by external energy curable resin-based material.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
YY/T 0631-2008 Determination of color stability of dental materials (ISO 7491:2000, IDT)
Category 3 The curable resin-based fissure sealants way will be divided into. Type I. chemical cure; II type. external energy curable.
4 Requirements
4.1 General Performance
Sealers from single or multi-component liquid composition, but also by a liquid and a powder or paste combination, in accordance with the manufacturer's instructions when When reconcile or curing sealants should meet the requirements of 4.2, 4.3 and 4.4.
4.2 Appearance of the components
In accordance with the manufacturer's instructions [8.3c)] operation, inspection (see 7.1), and color consistency of each component sealant should be uniform, no foreign body.
4.3 Curing of sealant
Appearance. sealer after curing in check (see 7.1) shall be the manufacturer's instructions [8.3a)] is consistent description.
4.4 Physical properties
4.4.1 I type sealant working time 7.2 testing, I type sealant working time should not be less than the manufacturer's instructions [8.3d)] indicate the time or not less than 45s, take two Who is greater.
4.4.2 Curing time I type sealant
7.3 test, the curing time I type sealer should be the manufacturer's instructions [8.3d)] indicated the time difference is not more than 30s; not More than 5min.
4.4.5 Depth of cure type II sealants
By 7.6 test, the depth of cure type II sealant should not be less than 1.5mm.
4.4.6 Uncured film thickness
By 7.7 testing, uncured sealant film thickness should be less than 0.1mm.
7.4 Polymerization starting time
Test by polymerization starting time type II sealant should not be less than 25s. Curing time 4.4.4 II type sealant
7.5 Curing time
Test, II type sealant curing time (required for complete cure is exposed to an external energy source so that time) should not exceed manufacturers say SHEET marked time or no more than 60s, whichever is less.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
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