YY/T 0844-2011 Laser therapeutic equipment—Pulsed carbon dioxide laser treating instrument
YY/T 0844-2011 Laser therapeutic equipment—Pulsed carbon dioxide laser treating instrument
Basic Information
Scope
This standard specifies the basic parameters, product composition, technical requirements, test methods, and marking labels, packaging, etc. of pulsed carbon dioxide laser therapy machines. This standard provides technical specifications for manufacturers of pulsed carbon dioxide laser therapy machines to formulate medical device registration product standards.
This standard applies to pulsed carbon dioxide laser therapy machines that only contain a pulsed operation mode and to the pulsed operation parts of carbon dioxide laser therapy machines that simultaneously contain a continuous wave operation mode and a pulsed operation mode (hereinafter referred to as "therapy machines"). In this standard, "pulse" refers to a pulse duration (pulse width) of less than 0.25 s. The therapy machines achieve the purpose of treatment by vaporizing, carbonizing, coagulating, and irradiating human tissues with pulsed lasers of a wavelength of 10.6 μm.
For carbon dioxide laser therapy machines that simultaneously contain a continuous wave operation mode and a pulsed operation mode, the continuous wave operation parts of these machines shall comply with GB 11748, and the pulsed operation parts of these machines shall comply with this standard.