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YY/T 0840-2011 English PDF (YY/T0840-2011)

YY/T 0840-2011 English PDF (YY/T0840-2011)

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YY/T 0840-2011: Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance

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Scope

This Standard is applicable to well-type radionuclide calibrators with gas-filled
ionization chambers used in nuclear medicine practice.
The purpose of this Standard is to determine the most important characteristics of the
radionuclide calibrator; and to specify the corresponding test methods; so that
manufacturers may declare the characteristics of their equipment in a standardized
way, and to facilitate the comparison between equipment.

Basic Data

Standard ID YY/T 0840-2011 (YY/T0840-2011)
Description (Translated English) Medical electrical equipment. Radionuclide calibrators. Particular methods for describing performance
Sector / Industry Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C43
Classification of International Standard 11.040.50
Word Count Estimation 12,135
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard GB/T 17857-1999; GB/T 24247-2009
Adopted Standard IEC 61303-1994, MOD
Regulation (derived from) State Food and Drug Administration Notice No. 106 of 2011
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to the use of nuclear medicine practice with a well-type ionization chamber inflatable radionuclide calibrator. This standard applies to determine radionuclide calibrator most important features and provides the corresponding test methods to enable manufacturers to use standardized way declare that their device characteristics, and to facilitate comparison between the devices.


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