ディスポーザブル医材の放射線滅菌線量の検討(I) : ディスポーザブル注射筒・注射針のBioburdenの調査および滅菌線量の算出

概要

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The bioburden and dose setting for radiation sterilization of disposable syringe and needle were examined, and the following results were obtained.1. The initial counts of organisms were observed on about 8,000 syringes and 1,500 needles. The maximum counts were 9 per syringe and 8 per needle. It was found that 75% of the syringes and 56% of the needles were not contaiminated by organisms.2. The D-value for these devices contaminated by organisms was measured. B. cereus indicated the highest radioresistance and its D-value was 0.20 Mrad.3. The radioresistance of B. pumilus (ATCC 27142) carried on various parts of them was measured. The diference in these radioresistances was not found.4. Sterility dose for these devices was obtained to be 1.12 Mrad by using the formula, SD=D×log (No/N). When the method mentioned in Appendix B of AAMI guideline was used, the sterility dose was 1.2-1.5 Mrad for the syringe and 1.3-1.6 Mrad for the needle.From the above results, it is fonud that 10^<-6> sterility assurance is obtained in less than 2.0 Mrad for the both of them.
日本医療機器学会の論文
1983-10-01