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YY 0711-2009: Dental absorbent points
Status: Obsolete
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Dental absorbent points
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YY 0711-2009
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Basic data | Standard ID | YY 0711-2009 (YY0711-2009) | | Description (Translated English) | Dental absorbent points | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 13,188 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | Quoted Standard | ISO 6360-1-1985 | | Adopted Standard | ISO 7551-1996, IDT | | Regulation (derived from) | Industry standard filing Notice 2009 No. 9 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard provides for the root canal treatment process unmedicated dental absorbent paper points and performance requirements and test methods. The performance requirements for sterilization by way of the production plant using sterilized dental absorbent paper after the first tip. Dental absorbent paper points including standard absorbent paper points and conical absorbent paper points. This standard does not specify a sterile and/or possible biological hazards performance requirements or test methods. | YY 0711-2009: Dental absorbent points---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 absorbent points
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
YY 0711-2009/ISO 7551.1996
Dental absorbent paper points
(ISO 7551.1996, IDT)
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
All technical contents of this standard is mandatory.
This standard is identical with ISO 7551.1996 "Dental absorbent paper points."
This standard is based on ISO 7551.1996 re-drafted in order to increase operability standards, made editorial changes, and they are
It relates to the terms of the margin identified by a single vertical line.
The main differences between the standard and the international standard and the reasons are as follows.
--- Delete references to normative documents ISO 3630-1.1992, the increase in Appendix A, which direct reference to international standards for content.
--- International standard original 4.1 "ISO 3630-1.1992 6.2" to "Appendix A".
--- International Standard Test Method description "If the manufacturer claims that the unopened package is sterile, the manufacturer shall provide 4.5
The statement confirmed that the test method shall be in accordance with local national standards. Without this national standard, the test should be consistent with the United States or
European Pharmacopoeia "is replaced by" if the manufacturer claims that the unopened package is sterile, the plant used to demonstrate the use of sterile statement
The inspection method should comply with Chinese pharmacopoeia sterility test method. "
--- 6.1 Add. "non-sterile samples."
--- Delete the original standard "Appendix A (informative)" was changed to "Reference" and the corresponding international standard to our standards.
--- Increase in Appendix A, the ISO 3630-1. 6.2 Content 1992 direct reference to the contents of this standard, to increase maneuverability.
Appendix A of this standard is a normative appendix.
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 is drafted by. State Food and Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Lin Hong, Li Yuan, Zhang Yan, Sun Zhihui, Bai Wei.
YY 0711-2009/ISO 7551.1996
Introduction
This standard specifies dental absorbent paper points size and YY 0495-2004 "root canal filling tip" in the corresponding root canal filling tip foot
Consistent inches.
This standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards when, see
Khao YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing."
Dental absorbent paper points in root canal therapy for drying the root canal or to the administration of the canal. Therefore, the need to use dental absorbent paper points excellent
Quality moisture absorption material. They close texture, to form a smooth surface without burrs. To insert the prepared root canal, dental absorbent paper points
You must have a certain rigidity, and sufficient standing upright circular cross section.
YY 0711-2009/ISO 7551.1996
Dental absorbent paper points
1 Scope
This standard specifies performance requirements and test methods for drug-free during root canal treatment of dental absorbent paper points.
The performance requirements apply to dental sterilization sterilization absorbent paper points used by the plant once after. Dental absorbent paper points including standard
Absorbent paper points and conical absorbent paper points.
This standard sterility test methods and performance requirements or/or possible biological hazards Not regulated.
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.
ISO 6360-1. 1985 Dental rotary instruments - digital coding system - Part 1. General characteristics
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Complete dental absorbent paper points.
3.2
Dental absorbent paper points of the narrow end.
3.3
The minimum package of dental absorbent paper points of sales, including a plurality of paper or one or a plurality of tip sizes.
3.4
Having a standard size and standard taper (length change in diameter per mm 0.02mm) paper tip.
3.5
Production plant to a predetermined size and taper of the tip paper.
4 Requirements
4.1 standard absorbent paper points size requirements
Standard absorbent paper points should be sized in accordance with Table 1 and Figure 1. In the range of a predetermined size allows different shapes and designs.
Test should refer to Appendix A of the provisions, and in accordance with this standard 6.2 and 6.3.
The tip of the tip of the paper should be rounded, conical or rounded shape. Neck should be a continuous cylindrical or conical, or both. Size should meet
Specified in Table 1 together.
4.2 cone absorbent paper points size requirements
4.2.1 Overview
The size of the cone-shaped absorbent paper points should meet the requirements of Figures 1 and 2. In the range of a predetermined size allows different shapes and designs.
YY 0711-2009/ISO 7551.1996
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