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YY/T 1420-2016Environmental requirement and test methods for medical ultrasonic equipment (English PDF)

医用超声设备环境要求及试验方法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1420-2016 is the English-translated version of 医用超声设备环境要求及试验方法.

YY/T 1420-2016 is the Chinese pharmaceutical industry standard that sets the particular environmental test requirements and methods for medical ultrasound equipment and systems: the climatic and mechanical conditions the equipment must withstand in transport, storage and use, the severity of each test and the checks of function and appearance that follow, so that the suitability of the equipment for the declared conditions can be judged. Issued on 26 January 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1420-2016

National Standard of the People's Republic of China

ICS: 11.040.50
Classification: C 41

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

Preface
1 Scope
2 normative reference document
3 Terms and definitions
4 Requirements
Appendix A (informative) Example of a B-type Ultrasonic Diagnostic Equipment Environmental Test Requirements
Appendix B (informative) Recommended environmental test grouping and testing project Reference

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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)

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

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

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

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment

GB 9760.1-2007

Cited by

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YY/T 0109-2024|YY/T 0865.1-2024|YY/T 0299-2022|YY/T 0642-2022|YY/T 1427-2016|GB 9706.205-2020

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