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YY/T 0162.1-2009 English PDF

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YY/T 0162.1-2009: Medical ultrasound equipment class series. Part 1: B mode ultrasound disgnostic equipment

YY/T 0162.1: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0162.1-2009English389 Add to Cart 3 days [Need to translate] Medical ultrasound equipment class series. Part 1: B mode ultrasound disgnostic equipment   YY/T 0162.1-2009
YY/T 0162.1-1994English279 Add to Cart 3 days [Need to translate] Class series of medical ultrasonic equipment Part 1: B mode ultrasonic diagnostic equipments Obsolete YY/T 0162.1-1994

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Basic data

Standard ID YY/T 0162.1-2009 (YY/T0162.1-2009)
Description (Translated English) Medical ultrasound equipment class series. Part 1: B mode ultrasound disgnostic equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C41
Classification of International Standard 11.040.55
Word Count Estimation 11,190
Date of Issue 2009-11-25
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY/T 0162.1-1994
Quoted Standard GB 10152-2009
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: B-type ultrasonic diagnostic equipment for each grade division method and device grade performance and should have condition. This standard applies to no more than the nominal frequency range of 15MHz B-type ultrasonic diagnostic equipment, as B-mode ultrasound diagnostic equipment division of grades within this range reference. This standard does not apply to ophthalmology ultrasound diagnostic equipment and intravascular ultrasound diagnostic equipment.

YY/T 0162.1-2009: Medical ultrasound equipment class series. Part 1: B mode ultrasound disgnostic equipment


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Medical ultrasound equipment class series.Part 1. B mode ultrasound disgnostic equipment ICS 11.040.55 C41 People's Republic of China pharmaceutical industry standards Replacing YY/T 0162.1-1994 Grade series of medical ultrasound equipment Part 1. B-type ultrasonic diagnostic equipment Posted 2009-11-15 2010-12-01 implementation State Food and Drug Administration issued

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. The main drafters of this section. Jiang Shilin, Wang Zhijian. This section was first released in May 1994. Grade series of medical ultrasound equipment Part 1. B-type ultrasonic diagnostic equipment

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. 3.1 Two at a predetermined depth in phantom, the scanning plane perpendicular to the axis of the ultrasonic beam direction, can be clearly displayed as two echo signals The minimum distance between the target line. Unit. millimeter (mm). 3.2 At a predetermined depth in phantom, along the axis of the ultrasonic beam can be displayed as the minimum distance between the two target line between the two echo signals. Unit. millimeter (mm). 3.3 Phantom surface acoustic window between the recent, can be clearly imaged phantom target line distance. Unit. millimeter (mm). 3.4 Phantom can be clearly imaged longitudinal linear target group farthest distance between the target and the line between the acoustic window. Unit. millimeter (mm). 3.5 Designer or manufacturer's published operating frequency of the ultrasound system.

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