YY 0460-2009Ultrasonics dental descaler equipment (English PDF)

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.

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.

4 Requirements