1 Scope
This standard specifies the basic parameters, product composition, technical requirements, test method as well as the mark, label and packaging requirements of Q-switched Nd: YAG laser ophthalmic system.
This standard is applicable to Q-switched Nd: YAG laser ophthalmic system (hereinafter referred to as system). The system is used for the incision and excision of anterior segment tissue through the photolysis/photoinduced blasting action of laser pulse with wavelength of 1064nm on human tissue to achieve the therapeutic aim.
2 Normative References
The following standards contain provisions which, through reference in this standard, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, all parties coming to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods (ISO 780:1997, MOD)
GB 7247.1-2001 Safety of Laser Products - Part 1: Equipment Classification, Requirements and User's Guide (idt IEC 60825-1:1993)
GB 9706.1-2007 Medical Electrical Equipment - Part 1: General Requirements for Safety (IEC 60601-1:1988, IDT)
GB 9706.20-2000 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment (idt IEC 60601-2-22:1995)
GB/T 14710-2009 The Environmental Requirement and Test Methods for Medical Electrical Equipment
YY 0065-2007 Ophthalmic Instruments - Slit-lamp Microscopes
3 Product Composition and Basic Parameters
3.1 Compositions of system:
a) Q-switched Nd: YAG laser;
b) Power supply and control system;
Foreword I
1 Scope
2 Normative References
3 Product Composition and Basic Parameters
4 Requirements
5 Test Method
6 Inspection Rules
7 Mark, Label and Operating Instructions
8 Packaging, Transportation and Storage
