摘要
从硬件参数标准、临床操作技术标准、信息的临床评价标准等方面,探讨中医类医疗器械脉诊检测装置的规范化。脉动信息采集系统相关标准的建立,为脉诊属性的数字化和量化提供了保障,同一类型的脉诊采集装置(如压力传感性脉诊仪)的相关硬件参数标准和生产流程标准可具有通用性。临床操作技术的规范化,使脉诊检测装置的操作有据可依,诊断设备操作技术标准的确立是该设备临床试验过程中实施质量控制的前提条件。脉诊"位、数、形、势"属性的数字化、量化的实现,基于不同提取技术获得的脉动信息图谱参数的规范是实现技术标准、准确分析脉动信息的关键。脉诊检测临床试验"金标准"脉象和评价标准的选择,保证了其重复稳定性、安全性和有效性。适当的具有中医特色的个性化标准的制定有助于逐步建立中医类诊断性医疗器械的新标准。
To probe into the normalization of medical equipment-pulse detecting installation from the aspects of hardware parameter criterion, clinical operation skills and information evaluation standard in clinic. The construction of pulse information collection system is a guarantee to digitalization and quantization of pulse diagnosis attributes. It can be universal that the relative hardware parameter criterion and production procedure standard of the same＇type of pulse collecting installation （such as pressure sensing equipment of pulse diagnosis）. The normalization of clinical operation skills is the base of the operation of pulse diagnosis equipment, and the establishment of operation criterion of diagnostic equipment is the precondition for quality controlling. The digitalization and quantization of pulse position, rhythm, shape and variance and standardization of pulse information parameters extracted based on different technology are key in realization of technology criterion and exact analysis of pulse information. The selection of pulse golden standard and review criterion in clinical experiment of pulse diagnostic equipment ensures its stability, security and effectiveness. Appropriate individualized criterion with TCM characteristics will be conducive to establish gradually new standard of TCM diagnosis equipments.
出处
《北京中医药大学学报》
CAS
CSCD
北大核心
2011年第12期847-850,共4页
Journal of Beijing University of Traditional Chinese Medicine
基金
国家自然科学基金资助项目(No.30973706)
"十一五"国家科技支撑计划资助项目(No.2007BAI07A23)
"十五"国家科技攻关项目(No.2004BA721A09)
教育部自主选题项目(No.JYB22-XS018)
关键词
脉诊检测装置
脉动信息
数字化
规范化
pulse information
digitization
medical equipment
normalization
