1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 22794 KS P ISO 22794:2009 2009 10 27 http:/www.kats.go.krKS P ISO 22794:2009 : ( ) ( ) () ( ) : () ( ) () () () () KS P ISO 22794:2009 : (http:/www.standard.go.kr) ： ：2009 10 27 2009-0653 ： ： ( 02-509-7266) (http:/www.kats.go.kr). 10 5 , . KS P ISO
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3、e 2007 1 ISO 22794, Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file , . 1 . ( 90 %) . , , . , , . 2 . . ( ) . KS P ISO 1942, KS P ISO 10993 1, 1： KS P ISO 10993 17, 17： KS P ISO 11135, KS P ISO 11137( ), KS P ISO 11607,
4、 KS P ISO 14155, KS P ISO 15223, , ISO 11134, Sterilization of health care products Requirements for validation and routine controlIndustrial moist heat sterilization ISO 13408 1, Aseptic processing of health care products Part 1： General requirements ISO 14937, Sterilization of health care products
5、 General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical KS P ISO 22794:2009 2 devices ISO 14971, Medical deives Application of risk management to medical devices EN 1041, 3 KS P ISO 1942 . 3.1 (bioco
6、mpatibility) a) b) 3.2 (biomaterial) a) , , , b) , / . 3.3 (filling) . 3.4 (augmentation) , 3.5 (resorption) / 3.6 (medicinal product) 4 , , . , , , , , ( ) . . KS P ISO 22794:2009 3 5 5.1 . , ( .) , . 5.2 , . X (XRD), (FTIR) / (DSC) , 100 % . ( , Ca/P, Ca/S) / / / ( , C/O/N), . International Center
7、 for Diffraction Data/Joint Committee on Powder Diffraction Standards(ICDD/JCPDS) . . 15, 16, 17, 18, 19 . 5.3 ( , , , / ) . . . ( , ) . . ( ) , . KS P ISO 22794:2009 4 5.4 , , . . . . ( / ) . . . ( , ) . . . . 5.5 5.5.1 KS P ISO 14971 . , KS P ISO 10993 1 / . . . , . , . 5.5.2 KS P ISO 22794:2009 5
8、 , . pH / . . ： . KS P ISO 10993 1 . a) / b) . ： ( , , , , , / ) . . 5.5.3 . . a) / b) . . KS P ISO 14155 . . KS P ISO 22794:2009 6 5.6 / . , . . 5.7 , / (TSE) . “ ” . ( , ) . 20, 21, 22, 23, 24, 25 . 5.8 5.8.1 10 6 . . . (EO) KS P ISO 11135 , KS P ISO 11137 , KS P ISO 11134 , ISO 14937 . , . 5.8.2
9、 . , (5.10.1 ). , ISO 13408 1 . 5.8.3 KS P ISO 10993 17 . 5.9 5.9.1 , . , ( , , ) KS P ISO 22794:2009 7 . 5.9.2 . , . KS P ISO 11607 . 5.10 5.10.1 . EN 1041 . KS P ISO 15223 . . 5.10.2 / . 5.10.3 . ( ) ( ) , KS P ISO 22794:2009 8 1 ISO 10993 2, Biological evaluation of medical devices Part 2： Anima
10、l welfare requirements 2 KS P ISO 10993 3, 3： , , 3 KS P ISO 10993 4, 4： 4 KS P ISO 10993 5, 5： 5 KS P ISO 10993 6, 6： 6 ISO 10993 7, Biological evaluation of medical devices Part 7 ： Ethylene oxide sterilization residuals 7 KS P ISO 10993 9, 9： 8 KS P ISO 10993 10, 10： 9 KS P ISO 10993 11, 11： 10 K
11、S P ISO 10993 12, 12： 11 ISO 14160, Sterilization of single-use medical devices incorporating materials of animal originValidation and routine control of sterilization by liquid chemical sterilants 12 KS P ISO TR 14283, 13 KS P ISO 14630, 14 EN 980, Graphical symbols for use in the labelling of medi
12、cal devices 15 ASTM F1088, REV A Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation 16 ASTM F1185, Standard Specification for Composition of Hydroxylapatite for Surgical Implants 17 United States Pharmacopoeia(USP) National Formulary(NF), Official Monograph for Calcium Su
13、lfate 18 KS P ISO 13779 1, 1： 19 U.S. Food and Drug Administration Class II Special Controls Guidance document： Dental Bone Grafting Material Devices 20 WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies： Report of a WHO consultation, Geneva, Switzerland, 23 26 March 1999
14、 WHO/CDS/CSR/APH/2000.3 (http:/www.who.int/csr/resources/publications/bse/whocdscsraph2003.pdf) 21 Guidance for FDA Reviewers and Industry： Medical Devices Containing Materials Derived from Animal Sources(Except for In Vitro Diagnostic Devices). US Department of Health and Human Services, Food and
15、Drug Administration, Center for Devices and Radiological Health, November 6, 1998 22 Guidelines for Infection Control in Dental Health-Care Settings 2003： US Department of Health and Human Services, Centers for Disease Control; MMWR Recommendations and ReportsDecember 19, 2003, Volume 52, No. RR 17
16、23 ISO 22442 1, Medical devices utilizing animal tissues and their derivatives Part 1： Application of risk management 24 ISO 22442 2, Medical devices utilizing animal tissues and their derivatives Part 2： Controls on sourcing, collection and handling 25 ISO 22442 3, Medical devices utilizing animal
17、tissues and their derivatives Part 3： Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy(TSE) agents 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ Korean Agency for Technology and Standards http:/www.kats.go.kr KS P ISO 22794:2009KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgeryContents of a technical file ICS 11.060.15
