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YY/T 0936-2014Particular specifications for urology X-ray equipment (English PDF)

泌尿X射线机专用技术条件

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

June 17, 2014

Implementation date

July 1, 2015

Scope

YY/T 0936-2014 is the English-translated version of 泌尿X射线机专用技术条件.

YY/T 0936-2014 is the Chinese standard "Particular specifications for urology X-ray equipment". Its scope clause reads: This standard specifies the urinary tract X-ray machine (referred to as the urinary machine) terms and definitions, classification and composition requirements and test methods.

This standard applies to the manufacturer's declaration dedicated to diagnostic imaging and minimally invasive surgery of the urinary system of X-ray equipment. Its clauses include terms and definitions.

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Document preview — YY/T 0936-2014

National Standard of the People's Republic of China

ICS: 11.040.50
Classification: C43

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references

1 Scope

This standard specifies the urinary tract X-ray machine (referred to as the urinary machine) terms and definitions, classification and composition requirements and test methods.

This standard applies to the manufacturer's declaration dedicated to diagnostic imaging and minimally invasive surgery of the urinary system of X-ray equipment.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

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

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety

GB 9706.3-2000 Medical electrical equipment - Part 2. High-voltage generator safety device requirements for diagnostic X-ray generator

GB 9706.11-1997 Medical electrical equipment - Part II. diagnostic X-ray source assemblies and X-ray tube assemblies

Claim

GB 9706.12-1997 Medical electrical equipment Part 1. General requirements for safety Collateral standard diagnostic X-ray radiation device.

General requirements for emission protection

GB 9706.14-1997 Medical electrical equipment - Part 2. Safety ancillary equipment requirements for X-ray equipment

GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard medical electrical systems security

Claim

GB/T 10149-1988 X-ray equipment for medical terminology and symbols

GB/T 10151-2008 medical diagnostic X-ray equipment voltage cable plug and socket

YY 0076-1992 metal parts coating technology classification conditions

YY/T 0106-2008 medical diagnostic X-ray machine general technical conditions

YY/T 0291-2007 medical X-ray equipment environmental requirements and test methods

YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests

YY/T 0708-2009 Medical electrical equipment - Part 1-4. General requirements for safety Collateral Standard. Programmable Electrical Medical Systems

3 Terms and Definitions

GB/T 10149-1988 define the following terms and definitions apply to this document.

3.1 Imaging time

Starting from generating X-rays on the screen shows the time required for a normal image.

3.2 Image brightness stability

Refers to the different attenuation phantom case, the image brightness constant automatic control.

3.3 Perspective recovery time

After the device is powered down in perspective, the system can be re-energized to operate the perspective of time.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 32 pages — is available in the English PDF.

Referenced standards

Normative references

GB 9706.3-2000 · GB 9706.11-1997 · GB 9706.14-1997

Similar standards

YY/T 0933|YY/T 0935|YY/T 0890|YY/T 0934

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