Studies on radiation sterilization of PVC transfusion bags and devices

Fuying He; Baogen Qian; Zhixiong Feng; Pei Li; Zongying Qin; Jiexian Lang; Yao Zhou; Laifeng Jin; Xueran Pang; Yaohua Chen; Lin Lu; Guiying Li

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Studies on radiation sterilization of PVC transfusion bags and devices

更新时间：2022-09-13

- Studies on radiation sterilization of PVC transfusion bags and devices
- Nuclear Techniques Vol. 10, Issue 7, (1987)
- 作者机构：
  
  1.中国科学院上海原子核研究所
  2.上海市中心血站
- 作者简介：
- 基金信息：
- DOI：
  CLC：
- Received：16 January 1987，
  
  Published：1987-07
- 稿件说明：
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Fuying He, Baogen Qian, Zhixiong Feng, et al. Studies on radiation sterilization of PVC transfusion bags and devices[J]. Nuclear techniques, 1987, 10(7): 9-14,60,61.
DOI：

Fuying He, Baogen Qian, Zhixiong Feng, et al. Studies on radiation sterilization of PVC transfusion bags and devices[J]. Nuclear techniques, 1987, 10(7): 9-14,60,61. DOI：

摘要

本文报道采用不同剂量

射线对大肠杆菌、甲型链球菌、卡他球菌、白色念珠菌、杂色曲霉和蜡状芽胞杆菌芽胞的抗辐射敏感性试验，从所制备的辐射生存曲线中获得上述各菌的

值为0.2、0.4、0.35、0.5、0.75和1.3kGy。当上述菌含菌量为10

—10

时，7kGy吸收剂量的灭菌效果达99.9999%以上。经7—10kGy吸收剂量照射后的聚氯乙烯材质在照射后7天和照射后保存2、4、6、8个月后，各项理化性能的指标均符合药典的要求；灭菌后的器材贮存至8个月均无菌无热源；急性毒性试验和临床220例试验的结果证明该消毒工艺安全可靠。

Abstract

The radio-resistance tests for E. Coli

-streptococcus

N-catanhalic

Candida albicans

Aspergillus rersico and Bacillus cureus spores by

-ray under the different doses were reported. From the logarithmic survive curve of irradiation

it was shown that D-values for the above spores were 0.2

0.4

0.35

0.5

0.75 and 1.3 kGy respectively. When the concentrations of spores were 10

—10

and absorbed dose was 7kGy

the efficiency of sterilization reached 99.9999%. The physical and chemical properties of PVC materials irradiated with 7-10kGy accorded with the pharmacopeia standard after the storage of 7 days to 8 months. The materials remained sterile and pyrogen-free after storage as long as 8 months.By the acute toxicity test and 220 cases of clinical test it was proved that this sterilization method was safe and reliable.

关键词

Keywords

references

The United States Pharmacopoeia , 20th ed. , official from July 1 , 1980 . the United States Pharmacopoeial Commission CI 979 .

厚生省药务局审查课，医疗用具制造申请の引（已订版） , 药剂日报社， 1982 , p, 58 。

佐藤健二等，放射线と产业， 24 , 30 （ 1983 ）.

中华人民共和国卫生部药典委员会编，中华人民共和国药典二部，人民出版社，北京， 1977 年。

古桥正吉等，医科器械学， 52 , 14 （ 1982 ）.

田中悟等，医枓器械学， 52 , 1 ， 21 （ 1982 ）.

杨明体，消毒与灭菌， 1 ， 1 ， 42 （ 1984 ）。

沈德林，消毒与灭菌 , 3 ， 42 （ 1986 ）。

佐藤健二等，放射线と产业， 9 , 32 （ 1978 ）.

立石恒夫等，医科器械学， 55 , 6 , 294 （ 1985 ）.

中国科学院和燃烧化学工业部编，塑料检验方法标准汇编，技术标准出版社，北京， 1983 年。

国际原子能机构，技术丛书，第72号， 1961 年。

佐藤健二等，放射线と产业， 19 , 25 （ 1981 ）.

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