KS P ISO 22794-2009 Dentistry－Implantable materials for bone filling and augmentation in oral and maxillofacial surgery－Contents of a technical file《牙科学 口腔和上颌面外科中骨填充物和增加物用植入材料 技术文档.pdf

《KS P ISO 22794-2009 Dentistry－Implantable materials for bone filling and augmentation in oral and maxillofacial surgery－Contents of a technical file《牙科学 口腔和上颌面外科中骨填充物和增加物用植入材料 技术文档.pdf》由会员分享，可在线阅读，更多相关《KS P ISO 22794-2009 Dentistry－Implantable materials for bone filling and augmentation in oral and maxillofacial surgery－Contents of a technical file《牙科学 口腔和上颌面外科中骨填充物和增加物用植入材料 技术文档.pdf（16页珍藏版）》请在麦多课文档分享上搜索。

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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

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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

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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