YY/T 1659-2019 Active Industry standards-Medicine

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

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

Publish Date: 2019-07-24 Implement Date: 2020-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1659-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical ultrasound, laser, and high-frequency instruments and equipment

ICS Name: Diagnostic equipment

Publish Date: 2019-07-24

Implement Date: 2020-08-01

Pages: 9 pages

Scope

This standard specifies the requirements and test methods for intravascular ultrasound diagnostic equipment (hereinafter referred to as the equipment). This standard applies to ultrasound diagnostic equipment for intravascular imaging with an acoustic working frequency of 60 MHz or lower. Note: Ultrasound transducer components used in human blood vessels can typically image within a 360° range. This standard does not consider all possible complex appearances and shapes of transducers. The test methods for parameters are based on 360° cylindrical imaging as an example. If necessary, users of this standard can apply the basic methods described in the standard to more complex designs.

Development Information

Word Count: 16 Thousand words Pages: 9 pages

Referenced Standards

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.9-1997 Medical electrical equipment—Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment GB 9706.9-2008 Medical electrical equipment—Part 2-37:Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY 0285.1-2004 Sterile,single-use intravascular catheters—Part 1:General requirements YY 0285.1-2017 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements YY/T 1420-2016 Environmental requirement and test methods for medical ultrasonic equipment YY 0285.1-1999 Disposable sterile intravascular catheter - Part 1: General requirements

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