This Standard specifies the purpose of environment test, test items, environment group, transport test, adaptability to power supply, standard test conditions, special situations, test procedures, test sequence, test requirements and test methods of medical X-ray equipment. This Standard is to evaluate the adaptability of equipment under various working environments and stimulation of storage and transport environment.
Basic Data
Standard ID
YY/T 0291-2007 (YY/T0291-2007)
Description (Translated English)
Environmental requirements and test methods for medical X-ray equipment
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C43
Classification of International Standard
11.040.50
Word Count Estimation
10,188
Date of Issue
2007-01-31
Date of Implementation
2008-01-01
Older Standard (superseded by this standard)
YY/T 0291-1997
Quoted Standard
GB 9706.1-1995; GB 9706.3-2000; GB/T 14710-1993
Regulation (derived from)
Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the medical X-ray equipment (hereinafter referred to as the device) Environmental testing purposes, pilot projects, environmental groups, transportation test, ability to adapt to the power, the benchmark test conditions, special cases, test procedures, test sequence, the test requirements and test methods. This standard applies to assess the work environment in a variety of devices and analog storage, transport environment adaptability.
