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医用激光设备注册检验常见性能指标及测试标准

2023-11-22 09:46:33
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测试要求
序号测试对象参数指标
1,激光器激光波长;
2,激光模式;
3,激光脉冲/脉冲串持续时间;
4,激光脉冲/脉冲串重复频率;
5,激光终端输出最大脉冲功率;
6,激光终端输出最大平均功率;
7,脉冲能量及对应脉冲持续时间;
8,激光终端脉冲能量;
9,治疗端面光斑尺寸;
10,激光终端输出功率/能量密度;
11,终端发散角或会聚角;
12,激光能量不稳定度;
13,激光能量复现性;
14,瞄准系统激光波长和功率;
15,防护镜光密度和透光率;
16,光纤外观和尺寸;
17,最大传输功率或能量;
18,发散角;
19,光纤传输效率;
 20,抗拉强度;
 21,最小弯曲工作半径;
 22,弯曲疲劳性;
 23,非平切光纤要求;
 24,外接应用端要求;
测试标准
序号标准编号标准名称(中文)标准名称(英文)
1,GB/T 11748 -2023 二氧化碳激光治疗机Carbon dioxide laser treating
instrument
2,GB/T 12257 -2023 氦氖激光治疗机通用技术条件General specification of He -
Ne laser medical equipment
3,YY 0789 -2010 Q 开关 Nd:YAG 激光眼科治疗机Q-Switched Nd.YAG laser
ophthalmic system
4,YY 0307 -2022激光治疗设备  掺钕钇铝石榴石激光治疗机Laser therapeutic equipment -
Nd:YAG Laser Equipment
5,YY/T 0844 -2011 激光治疗设备  脉冲二氧化碳激光治疗机Laser therapeutic equipment -
Pulsed carbon dioxide laser
treating instrument
6,YY 0845 -2011 激光治疗设备  半导体激光光动力治疗机Laser therapeutic equipment -
Diode laser equipment for
photodynamic therapy
7,YY 0846 -2011 激光治疗设备  掺钬钇铝石榴石激光治疗机Laser therapeutic equipment -
Ho:YAG laser equipment
8,YY 0983 -2016 激光治疗设备  红宝石激光治

疗机
Laser Therapy Equipment
Ruby Laser Therapy Machine
9,YY 1289 -2022 激光治疗设备  眼科激光光凝仪Laser Therapy Equipment
Ophthalmic Laser
Photocoagulator
10,YY 1300 -2016 激光治疗设备  脉冲掺钕钇铝石榴石激光治疗机Laser Therapy Equipment
Pulsed Nd-doped Yttrium
Aluminum Garnet Laser
Therapy Machine
11,YY 1301 -2016 激光治疗设备  铒激光治疗机Laser treatment equipment
Erbium laser treatment
machine
12,YY 1475 -2016 激光治疗设备  Q 开关掺钕钇铝石榴石激光治疗机Laser therapy equipment Q -
switched neodymium -doped
yttrium aluminum garnet laser
therapy machine
13,YY/T 0758 -2021 医用激光光纤通用要求General requirements for
medical laser fiber



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