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YY/T 1420-2016 English PDF

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YY/T 1420-2016: Environmental requirement and test methods for medical ultrasonic equipment
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Basic data

Standard ID YY/T 1420-2016 (YY/T1420-2016)
Description (Translated English) Environmental requirement and test methods for medical ultrasonic equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C41
Classification of International Standard 11.040.50
Word Count Estimation 10,141
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB 9760.1-2007; GB/T 14710-2009
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the special test requirements and test methods for environmental testing of medical ultrasound equipment (systems) (hereinafter referred to as equipment or systems). The purpose of this standard is to evaluate the adaptability of equipment or systems under specified environmental conditions for a variety of tests. This standard applies to all medical ultrasound equipment (systems).

YY/T 1420-2016: Environmental requirement and test methods for medical ultrasonic equipment

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Environmental requirements and test methods for medical ultrasonic equipment ICS 11.040.50 C41 People's Republic of China Pharmaceutical Industry Standard Environmental requirements and test methods for medical ultrasound equipment 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Requirements 1 Appendix A (informative) Example of a B-type Ultrasonic Diagnostic Equipment Environmental Test Requirements 4 Appendix B (informative) Recommended environmental test grouping and testing project 5 Reference 7

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Standardization Technical Committee of medical ultrasound equipment standardization sub-technical committee (SAC/TC10/SC2) Go back. The main drafting of this standard. the State Food and Drug Administration Hubei Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Jiang Shilin, Wang Zhijian, Wu Chengzhi, Fu Haitao. Environmental requirements and test methods for medical ultrasound equipment

1 Scope

This standard specifies the special test requirements and test methods for environmental testing of medical ultrasound equipment (systems) (hereinafter referred to as equipment or systems). The purpose of this standard is to evaluate the suitability of equipment or systems under specified environmental conditions for different tests. This standard applies to all medical ultrasound equipment (systems).

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Medical electrical equipment - Part 1. General requirements for safety GB 9706.1-2007 Environmental requirements and test methods for medical appliances GB/T 14710-2009

3 terms and definitions

The following definitions and definitions as defined in GB/T 14710-2009 apply to this document. 3.1 Medical ultrasound equipment (system) medicalultrasonicequipment (system) Produce ultrasound and its role in the human body, or the process and its effect has a supporting role in medical equipment. 3.2 Liquid crystal display liquidcrystalmodule Using a liquid crystal screen as a display part of the display. The liquid crystal display in this standard includes a touch screen. Note. rewrite 3.3 in SJ/T 11292-2003. 3.3 Touch screen touchscreen Also known as "touch screen" "touch panel", is a receiver can receive input signal such as inductive liquid crystal display device, when touched the screen The on-screen tactile feedback system can drive a variety of corresponding devices according to a pre-program.

4 requirements

4.1 General All applicable environmental requirements and test methods in GB/T 14710-2009 apply to medical ultrasound equipment, however GB/T 14710-2009 in Chapter 7 of the part of the requirements of the specific provisions and some special parts, you can use this standard. This standard The quasi-terms are recommended and do not contain all possible test states, GB/T 14710-2009 and this standard are not specified Or special test status, the manufacturer may specify. Appendix A is an example of the environmental test requirements for a B-type ultrasound diagnostic device. 4.2 Environmental test grouping The grouping of environmental tests is generally specified by the manufacturer. Table B.1 in Appendix B lists the recommended environment for some categories of medical ultrasound equipment

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