YY 0844-2011: Laser therapeutic equipment. Pulsed carbon dioxide laser treating instrument

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Scope

This standard specifies the basic parameters and product composition,
technical requirements, test methods, Marking labels and packaging of pulsed
carbon dioxide laser treatment instrument. This standard provides technical
specifications for manufacturers of pulsed carbon dioxide laser treatment
instrument to develop medical device registered product standards.
This standard is applicable to the pulsed operation section of the pulsed carbon
dioxide laser treatment instrument containing only a pulsed operation mode
AND the pulsed carbon dioxide laser treatment instrument containing both the
continuous wave operation mode and pulsed operation mode (hereinafter,
simply referred to as the treatment instrument) of a carbon dioxide laser
therapeutic apparatus including both a. The term “pulse” in this standard has
the pulse duration (pulse width) less than 0.25 s. The treatment instrument is,
via the pulse laser of wavelength 10.6 μm, conducting vaporization,
carbonization, coagulation and irradiation against the human tissue, in order to
achieve the purpose of treatment.
As for the pulsed carbon dioxide laser treatment instrument containing both the
continuous wave operation mode and pulsed operation mode, the continuous
wave operation mode shall comply with GB 11748, AND the pulsed operation
mode shall comply with this standard.

Basic Data

Standard ID	YY 0844-2011 (YY0844-2011)
Description (Translated English)	Laser therapeutic equipment. Pulsed carbon dioxide laser treating instrument
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C41
Classification of International Standard	11.040.60
Word Count Estimation	15,130
Date of Issue	2011-12-31
Date of Implementation	2013-06-01
Quoted Standard	GB/T 191; GB 7247.1; GB 9706.1; GB 9706.20; GB/T 14710; GB/T 17736; YY 91057; ISO 11146
Regulation (derived from)	State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the pulsed carbon dioxide laser treatment of the basic parameters and product composition, technical requirements, test methods, and signs labeling, packaging, etc., this standard pulsed carbon dioxide laser treatment for the manufacturer of medical devices registered product standards developed to provide technical specifications. This standard applies only to contain the pulse operation mode and pulsed carbon dioxide laser treatment machine containing both continuous wave operation mode, pulsed operation mode carbon dioxide laser treatment of pulsed operation section. This standard refers to "pulse", the pulse duration (pulse width) is less than 0. 25s. Treatment machine via a wavelength of 10. 6��m pulsed laser on human tissue vaporization, carbonization, freezing and irradiation, to achieve the purpose of treatment.