1 Scope
This standard specifies the definition, basic parameters, requirements, test methods, sampling, mark, label, packaging, etc. of Nd: YAG laser medical instrument with continuous wave.
This standard is applicable to Nd: YAG laser medical instrument with continuous wave with wavelength of 1064nm (hereinafter referred to as medical instrument). Medical instrument is able to coagulate, vaporize, carbonize and melt tissue.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the reference document (including any amendments) applies.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
GB 7247.1 Safety of Laser Products - Part 1: Equipment Classification, Requirements and User's Guide
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety
GB 9706.19-2000 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment
GB 9706.20 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment
GB/T 14710-2009 The Environmental Requirement and Test Methods for Medical Electrical Equipment
GB/T 17736-1999 Testing Method of Main Parameters for Laser Protective Eyewear
YY/T 0758 General Requirements for Therapeutic Laser Fiber
YY 91057-1999 General Specifications for Medical Foot Switch
ISO 11146 Lasers and Laser-related Equipment - Test Methods for Laser Beam Widths, Divergence Angles and Beam Propagation Ratios
3 Term, Definition and Symbols
3.1 Term and Definition
Foreword I
1 Scope
2 Normative References
3 Term, Definition and Symbols
4 Composition and Basic Parameters
5 Requirements
6 Test Methods
7 Inspection Rules
8 Mark, Label and Operating Instructions
9 Packaging, Transportation and Storage
