YY 0897-2013 in English
SUPERSEDEDRadio-frequency ablation equipment for ear,nose and throat
- Issued on:2013-10-21
- Implemented on:2014-10-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$214.00
本标准适用于包括相关附件在内,预期利用耳鼻喉射频消融电极将频率为200kHz~5MHz的射频能量传递到耳鼻喉部位的粘膜下靶组织,对其进行消融治疗的耳鼻喉射频消融设备。
本标准不适用于高频电灼设备。
Scope
This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation and storage of ENT radiofrequency ablation equipment. This standard applies to ENT radiofrequency ablation equipment (hereinafter referred to as equipment) as defined in 3.1. This standard does not apply to high-frequency electrocautery equipment.

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