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YY 0460-2009: Ultrasonics dental descaler equipment
Status: Obsolete YY 0460: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0460-2009 | English | 279 |
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Ultrasonics dental descaler equipment
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YY 0460-2009
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| YY 0460-2003 | English | 879 |
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PDF similar to YY 0460-2009
Basic data | Standard ID | YY 0460-2009 (YY0460-2009) | | Description (Translated English) | Ultrasonics dental descaler equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 7,782 | | Date of Issue | 2009-11-15 | | Date of Implementation | 2010-12-01 | | Older Standard (superseded by this standard) | YY 0460-2003 | | Quoted Standard | GB 9706.1-2007; GB/T 14710; YY/T 0751-2009 | | Regulation (derived from) | Industry standard filing Notice 2010 No. 2 (No. 122 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the ultrasonic scaler equipment terminology and definitions, requirements, test methods and inspection rules. This standard applies to 18kHz ~ 60kHz frequency range, from the ultrasonic transducer to generate a continuous or quasi- continuous wave ultrasonic energy ultrasonic teeth cleaning device (hereinafter referred to as the instrument). | YY 0460-2009: Ultrasonics dental descaler equipment---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.
Ultrasonics dental descaler equipment
ICS 11.060.20
C41
People's Republic of China pharmaceutical industry standards
Replacing YY 0460-2003
Ultrasonic scaler equipment
Posted 2009-11-15
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
4.5,4.9 and 4.10 of this standard is recommended requirements, the rest is mandatory.
This standard replaces YY 0460-2003 "ultrasonic scaler equipment."
This standard YY 0460-2003 compared to major changes are as follows.
a) delete the original standard Chapter 4, "symbol";
b) In Chapter 4, "Requirements", increasing the main vibrating tip manufacturer's published offset tip vibration frequency and half biasing force three indicators
The measured data with a predetermined deviation, an increase of instrument functional requirements;
c) simplify the exposition of the test method, the main performance test method of the present standard of a direct reference YY/T 0751-2009
(IEC 61205) "ultrasonic scaler device output characteristic measurement and disclosure";
d) simplifying the Chapter 7, "Inspection Rules" in the factory contents inspection;
e) delete the original standard Chapter 8 "signs and instructions for use";
f) Remove the original standard test used to describe the principle of the method and the informative Appendix A, Appendix B and Appendix D;
g) fully implement common safety standard GB 9706.1-2007, delete the original standard normative appendix C.
This standard by the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2)
Centralized.
This standard was drafted. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Wang Zhijian, busy Ashmore.
This standard was first released in June 2003.
Ultrasonic scaler equipment
1 Scope
This standard specifies the terms and definitions ultrasonic teeth cleaning equipment, requirements, test methods and inspection rules.
This standard applies in the 18kHz ~ 60kHz frequency range, by an ultrasonic transducer generates a continuous or quasi-continuous wave Doppler energy ultra
Acoustic teeth cleaning device (hereinafter referred to as the instrument).
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.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB/T 14710 medical electrical environmental requirements and test methods
YY/T 0751-2009 Ultrasonic Scaling Device Measurement and publish output characteristics (IEC 612051. 1988, IDT)
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Tip must be in contact with the slides, the applied force, so that the tip of the main vibrating 0.15N ± 0.02N offset falling under the conditions of contact force
50% lower.
3.2
In the role of the head from the tip of no more than 1mm from the point of maximum amplitude in the direction of the peak to peak displacement of the application head.
3.3
Effect tip of the fundamental frequency of vibration.
4 Requirements
4.1 main vibrating tip offset
Manufacturers should publish the main vibrating tip offset value in the random file.
Deviation published with the measured values should be within a range of ± 50% of or compliance with the manufacturer's specifications.
4.2 tip vibration frequency
Manufacturers should publish numerical tip vibration frequency in a random file.
Deviation published with the measured values should be within a range of ± 10% of or compliance with the manufacturer's specifications.
4.3 Semi-biasing force
Manufacturers shall publish half biasing force values in a random file.
Deviation published with the measured values should be within a range of ± 50% of or compliance with the manufacturer's specifications.
4.4 The main vibrating tip offset adjustment
Main vibrating tip offset should be adjusted, the adjustment range can be reduced to 50% of maximum.
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