中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2013年
4期
53-55
,共3页
眼用粘弹剂%光谱透过率%紫外区%可见区%近红外区
眼用粘彈劑%光譜透過率%紫外區%可見區%近紅外區
안용점탄제%광보투과솔%자외구%가견구%근홍외구
ophthalmic viscosurgical devices%spectral transmit ance%ultraviolet region%visible region%near infrared region
内容:为了明确眼用粘弹剂在注册检验时光谱透过率的评价方法,本文通过大量试验,对300~1100nm范围内的光谱透过率进行研究.结果发现,在整个波长范围内其光谱透过率没有规律,但大多产品到了紫外区就产生了一定的吸收,光谱透过率急剧下降,而在非紫外区则没有明显吸收,所以从不同的区域分别界定光谱透过率指标,即分为紫外区、可见区、近红外区分别进行界定是比较合理,同时也是比较可行的.本文为该类产品在注册检验时提供一定思路,同时也为产品的多样性制定出一个客观的检测指标提供一定的参考.
內容:為瞭明確眼用粘彈劑在註冊檢驗時光譜透過率的評價方法,本文通過大量試驗,對300~1100nm範圍內的光譜透過率進行研究.結果髮現,在整箇波長範圍內其光譜透過率沒有規律,但大多產品到瞭紫外區就產生瞭一定的吸收,光譜透過率急劇下降,而在非紫外區則沒有明顯吸收,所以從不同的區域分彆界定光譜透過率指標,即分為紫外區、可見區、近紅外區分彆進行界定是比較閤理,同時也是比較可行的.本文為該類產品在註冊檢驗時提供一定思路,同時也為產品的多樣性製定齣一箇客觀的檢測指標提供一定的參攷.
내용:위료명학안용점탄제재주책검험시광보투과솔적평개방법,본문통과대량시험,대300~1100nm범위내적광보투과솔진행연구.결과발현,재정개파장범위내기광보투과솔몰유규률,단대다산품도료자외구취산생료일정적흡수,광보투과솔급극하강,이재비자외구칙몰유명현흡수,소이종불동적구역분별계정광보투과솔지표,즉분위자외구、가견구、근홍외구분별진행계정시비교합리,동시야시비교가행적.본문위해류산품재주책검험시제공일정사로,동시야위산품적다양성제정출일개객관적검측지표제공일정적삼고.
To make clear the evaluation method of the spectral transmit ance of the ophthalmic viscosurgical devices in registration test, and the spectral transmit ance is researched in the wavelength range between 300nm and 1100nm by lots of experiments. The results are found that the spectral transmit ance is no law in the whole wavelength range, but many products produced certain absorption in ultraviolet region, and the spectral transmit ance sharp decline, however there is no obvious absorption except for the ultraviolet region, so the standard requirements of the spectral transmit ance are respectively limited in the different regions, such as ultraviolet region, visible region, and near infrared region. It is more reasonable and feasible, which can provide some ideas in registration test, and also can provide certain reference in establishing an objective detection requirement of diversity products.
