1、 KS J 0010 KSKSKSKS SKSKSKS KSKSKS SKSKS KSKS SKS KS , , , , , KS J 0010 : 2007 (2012 ) 2007 10 24 http:/www.kats.go.krKS J 0010：2007 ： ( ) ( ) KT&G ( ) : (http:/www.standard.go.kr) ： ：2002 11 30 ：2007 10 24 ：2012 12 27 ： 20120774 ： ( 02-509-7270) (http:/www.kats.go.kr). 10 5 , . KS J 0010：2007 ii 1
2、 1 2 1 3 .1 4 .2 5 .2 6 3 7 .4 A() 6 i KS J 0010：2007 ii , . , . DNA . 1 . KS J 0010 : 2007 (2012 ) , , , , , Biotechnology Standard practice for preservation by freezing, freeze drying, and low temperature maintenance of bacteria, fungi, protista, viruses, genetic elements, and animal and plant tis
3、sues 1 1.1 , (, ), ( ) () . 1.2 , . 1.3 , , . 2 . 1.4 . . 6. . 2 . . ( ) . 2.1 ASTM E 1564, Guide for Design and Maintenance of LowTemperature Storage Facilities for Maintaining Cryopreserved Biological Materials E 1565, Guide for Inventory Control and Handling of Biological Materials Maintained at
4、Low Temperatures E 1566, Guide for Handling Hazardous Biological Materials in Liquid Nitrogen 3 . KS J 0010：2007 3.1 (cryogenic temperature) 100 3.2 (cryoprotectant) 3.3 (eutectic temperature) 3.4 (freezedrying) 3.5 (freezing) . 3.6 (low temperature preservation) . 3.7 (vitrification) . 4 4.1 , . 34
5、2 , . 5 5.1 (, ) . . 1 2 . . 5.2 35 1 10 . 35 . 35 (, 50 100 /) . () . 4,5 2 KS J 0010：2007 5 10 . , . . 5.3 . . 5.3.1 10 . , . . 5.3.2 (vapor storage liquid nitrogen freezer) , . 150 . . 65.4 . . . . . , . 5.5 . , , , , , . 6 6.1 , . , 2 8 . 6.2 3 KS J 0010：2007 6.2.1 . 40 . . . (molded vial) . 6.
6、2.2 10 mHg(0.01 torr) 20 . 50 mHg(0.05 torr) . . 7 50 mHg . 6.2.3 , (closed system) . (, O 2 ) (backfilling) . 0.22 m , . . 6.2.4 , . , 8 . , . 6.3 , 10 . . 2 8 . . . 96.4 . , , , , , , , , , . 7 7.1 (150 ) . , . . 10 . . . 4 KS J 0010：2007 7.2 , . , . 7.3 , . . . . 7.4 , ( ) . . 7.5 . . , . . OSHA
7、 5 KS J 0010：2007 6 A () 1 AshwoodSmith, M. J., and Grant, E., “Mutation Induction in Bacteria by FreezingDrying”, Cryobiology, Vol 13, 1976, pp. 206213 2 Richardson, J. H., and Barkley, W. E., Biosafety in Microbiological and Biomedical Laboratories, U. S. Department of Health and Human Services,
8、HHS Publication No.(CDC) 938395, U. S. Government Printing Office, Washington DC, 1993 3 Simione, F. P., “Key Issue Relating to the Genetic Stability and Preservation of Cell Banks”, Journal of Parenteral Science and Technology, Vol 46, 1992, pp. 226232 4 Jutte, H. P. M., Heyse, P., Jansen, H. G., B
9、ruining, G. J., and Zeilmarker, G. H., “Vitrification of Mouse Islets of Langerhans：Comparison With a More Conventional Freezing Method”, Cryobiology, Vol 24, 1987, pp.292302 5 Rall, W. F., and Fahy, G. M., “IceFree Cryopreservation of Mouse Embryo at 196 By Vitrification”, Nature(London), Vol 313,
10、1985, pp. 573575 6 Simione, F. P., and Karpinsky, J. Z. “Points to Consider Before Validating a Liquid Nitrogen Freezer”, Validation Practices for Biotechnolgy Products, ASTM STP 1260, James K. Shillenn, Ed., American Society for Testing and Materials, 1996 7 Nail, S. L., “The Effect of Chamber Pres
11、sure on Heat Transfer in the FreezeDrying of Parenteral Solutions”, Journal of the Parenteral Drug Association, Vol 34, 1980 8 Barbaree, J. M., and Sanchez, A., “Cross Contamination During Lyphillization”, Cryobiology, Vol 19, 1982, pp. 443447 9 Barbaree, J. M., and Smith, S., “Loss of Vacuum in Rub
12、ber Stoppered Vials Stored in Liquid Nitrogen Vapor Phase Freezer”, Cryobiology, Vol 18, 1981, pp. 528531 10 Greiff, D., Melton, H., and Rowe, T. W., “On the Sealing of GasFilled Glass Ampoules”, Cryobiology, Vol 12, 1975, pp. 114 , , , , , 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ KS J 00
13、10 ：2007KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Biotechnology Standard practice for preservation by freezing, freeze drying, and low temperature maintenance of bacteria, fungi, protista, viruses, genetic elements, and animal and plant tissues ICS 07.080 Korean Agency for Technology and Standards http:/www.kats.go.kr
