YY 0844-2011 (English Version) PDF

Scope: This standard specifies the basic parameters and product composition, technical requirements, test methods, 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 product standards for medical device registration. This standard applies to the pulse operation part of the pulse carbon dioxide laser therapy machine that only contains pulse operation mode and the carbon dioxide laser therapy machine that contains both continuous wave operation mode and pulse operation mode (hereinafter referred to as the treatment machine). The "pulse" referred to in this standard has a pulse duration (pulse width) less than 0.25s. The treatment machine achieves the purpose of treatment by vaporizing, carbonizing, coagulating and irradiating human tissue with a pulse laser with a wavelength of 10.6 μm. For carbon dioxide laser therapy machines that contain both continuous operation and pulse operation, the continuously operated part should comply with GB 11748, and the pulsed operation part should comply with this standard.

YY 0844-2011 Referenced Document

GB 7247.1 Safety of laser products.Part 1:Equipment classification and requirements*， 2012-12-31 Update
GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*， 2020-04-09 Update
GB 9706.20 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
GB/T 17736 Testing method of main parameters for laser protective eyewear
GB/T 191 Packaging.Pictorial marking for handling of goods
ISO 11146 Laser and laser-related equipment - Test methods for laser beam parameters - Beam widths, divergence angle and beam propagation factor
YY 91057 General specifications for medical foot switch

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