KS P 1600-2007 General guideline of safety test for the cell based therapeutic substances《细胞基础治疗的安全性试验一般通用标准》.pdf

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2、3 5 3 6 4 6.1 .4 6.2 (cells) .5 6.3 .6 6.4 6 7 .6 7.1 .6 7.2 6 8 .7 8.1 .7 8.2 .7 8.3 7 8.4 .7 9 .7 9.1 , 7 9.2 , 7 10 .8 10.1 .8 10.2 8 10.3 8 10.4 8 11 (risk management) 8 12 .8 12.1 .9 12.2 .9 13 9 KS P 1600： 2007 ii 13.1 .9 13.2 .9 13.3 9 13.4 .9 KS P 1600： 2007 iii . 05 “ ” , . ( ) 4 ( ) 16 2(

3、) (06.10.16, 2006 0543 ) , 06 12 07 6 4 . ( ) 4 ( ) 18 ( ) (07.08.16) (07.08.23, ) (07.08.31, 2007 0592 ) . KS P 1600： 2007 (2012 ) General guideline of safety test for the cell based therapeutic substances 1 . 1 . 2 . , . 2 . . ( ) . KS A 9000_2001, KS P ISO 10993 1, 1： KS P ISO 14630, ISO 10993 7：

4、 1995, Biological evaluation of medical devices Part 7： Ethylene oxide sterilization residuals ISO 11607 1： 2006, Packaging for terminally sterilized medical devices Part 1： Requirements for materials, sterile barrier systems and packaging systems ISO 11607 2： 2006, Packaging for terminally steriliz

5、ed medical devices Part 2： Validation requirements for forming, sealing and assembly processes ISO 13485 ： 2003, Medical devices Quality management systems Requirements for regulatory purposes ISO 14155 1： 2003, Clinical investigation of medical devices for human subjects Part 1： General requirement

6、s ISO 14155 2： 2003, Clinical investigation of medical devices for human subjects Part 2： Clinical investigation plans ISO 14971： 2000, Medical devices Application of risk management to medical devices ISO/FDIS 22442 1, Medical devices utilizing animal tissues and their derivatives Part 1： Applicati

7、on of risk management ISO/FDIS 22442 2, Medical devices utilizing animal tissues and their derivatives Part 2： Controls on KS P 1600： 2007 2 sourcing, collection and handling 3 3.1 (cell-based therapeutics) , , , , . , . 3.2 (autogeneic autologous) , , . 3.3 (allogeneic) (species) , , . 3.4 (xenogen

8、eic) , , . 3.5 , , . 3.6 (therapeutic cell) , , , , 3.7 (tissue engineered medical product) , , , . , . 3.8 (artificial tissue structural components) , , , , (scaffold) 3.9 (scaffold) , , , KS P 1600： 2007 3 3.10 (good manufacturing practice) 3.11 (good tissue practice) , . 3.12 (good clinical pract

9、ice) 4 . . , 5 5.1 . a) , , , , , b) c) , , d) (transformation), , e) (6. ), , . (aging) (6. 7. ) f) (6. 7. ) g) , (6. 7. ) KS P 1600： 2007 4 h) i) j) (6. 7. ) k) (13. ) l) , (7. ) m) ( ) (7. ) n) o) , (6. 13. ) (MRI) . p) , , q) r) s) t) u) , . 7. . 5.2 (GTP) , , , (GMP) . 6 6.1 , , , . , , , , . ,

10、 KS P 1600： 2007 5 . 1 . , . a) KS P ISO 10993 1 b) (GCP) ISO 22442 1( ), ISO 22442 2( , ) ISO 22442 3( / TSE ) . . 2 , , (GTP) (GMP) . 3 . 6.2 (cells) 6.2.1 (donner cell selection) . 1 . . . . , (hamydia), (septicaemia) (bacteraemia), (pyasmia), (toxemia) , , , (spongiform encephalopathy) ISO 22442

11、 2 . 2 (GTP) . KS P 1600： 2007 6 6.2.2 (intact cells) ( / / ), ( ), ( , , ) ( , , ) . 6.3 . 1 KS P ISO 10993 1 . 2 . 6.4 (GMP) . 7 7.1 (GMP) , . 1 (GMP) ISO 13485 . . , , 2 (GMP) ISO 13485 , (GTP) . . 7.2 . KS P 1600： 2007 7 . , ISO/TC215 . (GTP) , , . (GMP) . 8 8.1 . , . . ( , , X , , , ) . 8.2 ISO

12、/TC198 . 8.3 KS P ISO 10993 1( ) . ISO 10993 7 . . 8.4 , ISO 22442 3 . 9 9.1 , , ( , , ). , . , . . , . 9.2 , KS P 1600： 2007 8 , , “ ” . 10 10.1 . , . . 10.2 , / . 10.3 . (batch) ( ) . 10.4 , (： “ ” “ ”). . 11 (risk management) . . . , ISO 14971 ISO 22442 1 . 12 KS P 1600： 2007 9 12.1 ISO 10993 . 1

13、2.2 . 13 13.1 , . . ISO 14971 (GCP) , . 13.2 ISO 14971 . a) b) 13.3 , ISO 14155 1 ISO 14155 2 (GCP) . 13.4 . (end point analysis) . 153787 1 145 3(16) (02)26240114 (02)26240148 http:/ KS P 1600： 2007KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS General guideline of safety test for the cell based therapeutic substances ICS 11.040.40 Korean Agency for Technology and Standards http:/www.kats.go.kr