YY/T 0758-2009 (English Version) PDF

Scope: This standard specifies general requirements for therapeutic laser fibers. This standard applies to therapeutic laser fibers. Optical fiber refers to a product that uses optical fiber as the laser propagation medium and uses light energy for treatment. The optical fibers applicable to this standard do not include therapeutic optical fibers with inspection and diagnostic functions. Infrared hollow core waveguide not included. If the optical fiber forms part of the equipment and cannot be removed from the equipment, the equipment must comply with relevant national standards (such as GB 9706.1, GB 9706.20, GB 7247.1, etc.) and refer to this standard. However, if the optical fiber can be removed from the equipment, the removed unit shall comply with the requirements of this standard.

YY/T 0758-2009 Referenced Document

GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
GB 9706.20-2000 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use.Part 1:Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products