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Database: 189759 (19 Oct 2025)
YY 0284-2004 English PDF
YY 0284: Evolution and historical versions
Standard ID
Contents [version]
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Standard Title (Description)
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YY 0284-2004
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The general specification of He-Ne laser medical instrument for ILIB
Obsolete
YY 0284-2004
YY 0284-1996
English
439
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4 days [Need to translate]
The general specification of He-Ne laser medical instrument for ILIB
Obsolete
YY 0284-1996
PDF similar to YY 0284-2004
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Basic data
Standard ID
YY 0284-2004 (YY0284-2004)
Description (Translated English)
The general specification of He-Ne laser medical instrument for ILIB
Sector / Industry
Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard
C41
Classification of International Standard
11.040.50
Word Count Estimation
29,285
Date of Issue
2004-03-23
Date of Implementation
2005-01-01
Older Standard (superseded by this standard)
YY 0284-1996
Quoted Standard
GB/T 191-2000; GB/T 2828-1987; GB/T 2829-2002; GB 7247.1-2001; GB 9706.1-1995; GB 9706.20-2000; GB/T 14233.1-1998; GB/T 14233.2-1993; GB/T 14710-1993; YY 91055-1999; YY 0076-1992; YY/T 0193-1994
Regulation (derived from)
SFDA [2004] No. 86
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the He-Ne laser intravascular irradiation therapy instrument (hereinafter referred to internally illuminated instrument) of the definition, classification, requirements, test methods, sampling and marking, labeling, and packaging requirements. This standard applies to a wavelength of 632. 8nm continuous wave, low-power helium-neon laser internally illuminated instrument. The instrument used for intravascular laser irradiation for the treatment of blood circulation. Intravascular irradiation with helium-neon laser multifunction features illuminated instrument should also refer to the use of this standard. For other sources of internally illuminated instrument, in case no specific standard, this standard can be used as one of its security requirements applicable guidelines, but does not include the special requirements of the instrument.