Standard No.:	YY 0307-2011
English Name:	Nd:YAG laser medical instrument with continuous wave(CW)
Chinese Name:	连续波掺钕钇铝石榴石激光治疗机
Chinese Classification:	C41    Medical ultrasound, laser, high-frequency instrument and equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.60 11.040.60    Therapy equipment 11.040.60
Issued by:	China Food and Drug Administration
Issued on:	2011-12-31
Implemented on:	2013-6-1
Status:	to be superseded
Superseded by:	YY 0307-2022 Laser therapeutic equipment-Nd: YAG Laser Equipment
Superseded on:	2025-6-1
Language:	English
File Format:	PDF
Word Count:	7000 words
Price(USD):	170.0
Delivery:	via email in 1 business day

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