YY/T 0162.1-2009Medical ultrasound equipment class series - Part 1: B-mode ultrasound diagnostic equipment (English PDF)

Foreword

YY/T 0162 "series of medical ultrasound equipment grade" intends publishing into parts, each part will be divided according to different products. Current plan Post the following components.

--- The first part 1. B-type ultrasonic diagnostic equipment; Other parts are under consideration. This section YY/T Section 10162 of.

This section instead of YY/T 0162.1-1994 "grade series of medical ultrasound equipment The first part. B type ultrasonic diagnostic equipment." Section compared with YY/T 0162.1-1994 The main changes are as follows.

--- According to the current development of technology to improve some of the technical requirements of the indicators;

--- The "functional requirements" to "should have the conditions";

--- Added two terminology, the "all-digital (type)" and "Dynamic Range";

--- Adds an informative annex, the "all-digital ultrasound diagnostic equipment";

--- Re-division of the frequency band. Appendix A of this section is informative appendix.

This part of the standardization of medical ultrasound equipment for medical appliances National Standardization Technical Committee Technical Committee (SAC/TC10/SC2) Centralized.

This section drafted by. State Food and Drug Administration of Hubei Medical Device Quality Supervision and Inspection Center.

1 Scope

YY/T 0162 provisions of this part of the performance of B-type ultrasonic diagnostic equipment grade division method and apparatus of various grades and should be a Conditions equipment.

This section applies to the nominal frequency of not more than B-type ultrasonic diagnostic equipment within the 15MHz range as B-mode ultrasound diagnosis within this range Equipment divided grade reference.

This section does not apply to professional ophthalmic ultrasound diagnostic equipment and intravascular ultrasound diagnostic equipment.

2 Normative references

The following documents contain provisions which, through reference YY/T 0162 and become part of the provisions of this section. For dated references, All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

GB 10152-2009 B-type ultrasonic diagnostic equipment

3 Terms and Definitions

The following terms and definitions apply YY/T 0162 to the present section.