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YY 0622-2008: Dental resin-based pit and fissure sealants
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0622-2008 | English | 194 |
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Dental resin-based pit and fissure sealants
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YY 0622-2008
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Basic data | Standard ID | YY 0622-2008 (YY0622-2008) | | Description (Translated English) | Dental resin-based pit and fissure sealants | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 10,191 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-12-01 | | Quoted Standard | YY/T 0631-2008 | | Adopted Standard | ISO 6874-1988, IDT | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard provides for the closure of dental resin-based fissure point gap material performance requirements and test methods. This standard applies to chemical curing and by external energy curable resin based materials. | YY 0622-2008: Dental resin-based pit and fissure sealants---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.
Dental resin-based pit and fissure sealants
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
YY 0622-2008/ISO 6874. 1988
Dental resin-based fissure sealants
(ISO 6874. 1988, IDT)
Posted 2008-04-25
2009-12-01 implementation
State Food and Drug Administration issued
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.
This standard was proposed by the State Food and Drug Administration.
This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment.
This standard by the State Food and Drug Administration Peking University Medical Device Quality Supervision and Testing Center is responsible for drafting.
The main drafters of this standard. Lin Hong, Zhang Yan, Sun Zhihui, a Liu Zheng Gang.
YY 0622-2008/ISO 6874. 1988
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
YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing."
YY 0622-2008/ISO 6874. 1988
Dental resin-based fissure sealants
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.
4.4.3 Type Ⅱ sensitivity to ambient light blocking agent
7.4 Test by polymerization starting time type Ⅱ sealant should not be less than 25s.
Curing time 4.4.4 Ⅱ type sealant
7.5 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.
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.
YY 0622-2008/ISO 6874. 1988
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