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YY/T 1659-2019General technical requirements for intravascular ultrasound(IVUS) diagnostic equipment (English PDF)

血管内超声诊断设备通用技术要求

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Issued by

National Medical Products Administration of the People's Republic of China

Level / Type

Industry · Recommended

Issue date

July 24, 2019

Implementation date

August 1, 2020

Scope

YY/T 1659-2019 is the English-translated version of 血管内超声诊断设备通用技术要求.

YY/T 1659-2019 is the Chinese standard "General technical requirements for intravascular ultrasound(IVUS) diagnostic equipment". Its scope clause reads: This standard specifies the requirements and test methods for intravascular ultrasound diagnostic equipment (hereinafter referred to as equipment).

This standard applies to ultrasound diagnostic equipment for intravascular imaging with acoustic operating frequencies of 60 MHz and below. Note. Ultrasonic transducer assemblies for use in human blood vessels can typically be imaged over a 360° range.

This standard does not consider all possible complex appearances of the transducer And shape, the test method of the parameters is taken as an example of 360° cylindrical imaging.

If necessary, the user of this standard can use the basic method described in the standard to be more complicated. Design to apply. Its clauses include terms and definitions.

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Document preview — YY/T 1659-2019

National Standard of the People's Republic of China

ICS: 11.040.55
Classification: C 41

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and definitions
3.

1 Scope

This standard specifies the requirements and test methods for intravascular ultrasound diagnostic equipment (hereinafter referred to as equipment).

This standard applies to ultrasound diagnostic equipment for intravascular imaging with acoustic operating frequencies of 60 MHz and below.

Note. Ultrasonic transducer assemblies for use in human blood vessels can typically be imaged over a 360° range. This standard does not consider all possible complex appearances of the transducer

And shape, the test method of the parameters is taken as an example of 360° cylindrical imaging. If necessary, the user of this standard can use the basic method described in the standard to be more complicated.

Design to apply.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.

Pieces. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.9 Medical electrical equipment - Part 2-37. Particular requirements for safety of ultrasonic diagnostic and monitoring equipment

GB/T 14710 Medical electrical requirements and test methods

YY 0285.1 Intravascular catheters - Sterile catheters - Part 1 . General requirements

YY/T 1420 Medical Ultrasound Equipment Environmental Requirements and Test Methods

3 Terms and definitions

The following terms and definitions as defined in GB 9706.1, GB 9706.9 and YY 0285.1 apply to this document.

3.1 Intravascular ultrasound diagnostic equipment

For medical examination of intravascular ultrasound, medical electronics consisting of a host and a mating ultrasound transducer assembly intervening in the human blood vessels device.

3.2 Test piece testobject

An ultrasonic echo imaging performance detecting device composed of one or more sets of target structures.

3.3 Imaging radius

A longitudinal linear target group that can be clearly imaged in the test piece or between the farthest target line in the target and the geometric central axis of the ultrasonic transducer assembly distance.

Note. The unit is millimeter (mm).

3.4 Retraction direction resolution

The minimum distance between the two target lines of the two clear echo signals can be displayed when the transducer is retracted radially along the catheter.

Note. The unit is millimeter (mm).

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.9

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