"Biological evaluation" CNS Standards List| Hydrochloric acid | Pins Adjustable | Method Test | High Speed | Testing Standard | Method Test | Polyacrylonitrile Spun | Method Test | |
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CNS 14393-20
2020 Edition Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices 醫療器æ生物性評估ï¼ç¬¬ï¼’ï¼éƒ¨ï¼šé†«ç™‚器æå…疫毒ç†å¸è©¦é©—之原ç†èˆ‡æ–¹æ³• |
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CNS 14393-7
2018 Edition Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals 醫療器æ生物性評估ï¼ç¬¬ï¼—部：環氧乙烷滅èŒä¹‹æ®˜ç•™ç‰© |
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CNS 14393-1
2018 Edition Biological evaluation of medical devices – Part 1：Evaluation and testing 醫療器æ生物性評估ï¼ç¬¬ä¸€éƒ¨åˆ†ï¼šè©•ä¼°èˆ‡è©¦é©— |
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CNS 15153
2018 Edition Biological evaluation of medicaldevices - Part 17 : Establishment of allowable limits for leachable substances 醫療器æ生物性評估ï¼ç¬¬ï¼‘７部：å¯æº¶å‡ºç‰©è³ªå®¹å¿é™é‡ä¹‹å»ºç«‹ |
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CNS 14393-5
2018 Edition Biological evaluation of medical devices – Part 5：Tests for in vitro cytotoxicity 醫療器æ生物性評估 ï¼ç¬¬äº”部分：體外細胞毒性試驗 |
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CNS 14393-13
2018 Edition Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 醫療器æ生物性評估ï¼ç¬¬ï¼‘３部：èšåˆç‰©é†«ç™‚器æé™è§£ç”¢ç‰©ä¹‹é‘‘別åŠå®šé‡ |
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CNS 14393-9
2018 Edition Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 醫療器æ生物性評估ï¼ç¬¬ï¼™éƒ¨ï¼šæ½›åœ¨é™è§£ç”¢ç‰©ä¹‹é‘‘別åŠå®šé‡åˆ†æžæž¶æ§‹ |
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CNS 14393-6
2018 Edition Biological evaluation of medical devices - Part 6：Tests for local effects after implantation 醫療器æ生物性評估ï¼ç¬¬å…部分:æ¤å…¥å¾Œçš„局部效應測試 |
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CNS 14393-3
2018 Edition Biological evaluation of medical devices – Part 3：Tests for genotoxicity, carcinogenicity and reproductive toxicity 醫療器æ生物性評估ï¼ç¬¬ä¸‰éƒ¨åˆ†ï¼šåŸºå› 毒性ã€è‡´ç™Œæ€§èˆ‡ç”Ÿæ®–毒性之試驗 |
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CNS 14393-8
2018 Edition Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests 醫療器æ生物性評估ï¼ç¬¬ï¼˜éƒ¨ï¼šç”Ÿç‰©æ¸¬è©¦ç”¨åƒè€ƒæ料之é¸æ“‡åŠè³‡æ ¼èªå®š |
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CNS 15155
2018 Edition Biological evaluation of medical devices - Part 19 : Physico-chemical, morphological and topographical characterization of materials 醫療器æ生物性評估ï¼ç¬¬ï¼‘９部：æ料之物ç†åŒ–å¸ã€å½¢æ…‹åŠæ‹“æ’²å¸çš„ç‰¹æ€§åˆ†æž |
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CNS 14393-4
2018 Edition Biological evaluation of medical devices – Part 4：Selection of tests for interactions with blood 醫療器æ生物性評估ï¼ç¬¬å››éƒ¨åˆ†ï¼šè¡€æ¶²æŽ¥è§¸ç‰¹æ€§æ¸¬è©¦æ–¹æ³•çš„é¸æ“‡ |
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CNS 14393-2
2018 Edition Biological evaluation of medical devices — Part 2：Animal welfare requirements 醫療器æ生物性評估ï¼ç¬¬äºŒéƒ¨åˆ†ï¼šå‹•ç‰©ç¦åˆ©ä¹‹è¦å®š |
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CNS 14393-12
2018 Edition Biological evaluation of medical devices - Part 12: Sample preparation and reference materials 醫療器æ生物性評估ï¼ç¬¬ï¼‘２部：樣å“製備åŠåƒè€ƒææ–™ |
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CNS 15154
2018 Edition Biological evaluation of medical devices - Part 18 : Chemical characterization of materials 醫療器æ生物性評估ï¼ç¬¬ï¼‘８部：æ料之化å¸ç‰¹æ€§ |
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CNS 14393-14
2018 Edition Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics 醫療器æ生物性評估ï¼ç¬¬ï¼‘４部：陶瓷é™è§£ç”¢ç‰©ä¹‹é‘‘別åŠå®šé‡ |
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CNS 14393-15
2018 Edition Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys 醫療器æ生物性評估ï¼ç¬¬ï¼‘５部：金屬åŠåˆé‡‘之é™è§£ç”¢ç‰©çš„鑑別åŠå®šé‡ |
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CNS 14393-10
2018 Edition Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity 醫療器æ生物性評估ï¼ç¬¬ï¼‘ï¼éƒ¨ï¼šåˆºæ¿€æ€§åŠå»¶é²åž‹éŽæ•æ€§æ¸¬è©¦ |
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CNS 14393-16
2018 Edition Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables 醫療器æç”Ÿç‰©æ€§è©•ä¼°ï¼ ç¬¬ï¼‘ï¼–éƒ¨ï¼šé™è§£ç”¢ç‰©èˆ‡å¯æº¶å‡ºç‰©æ¯’性動力å¸ä¹‹ç ”究è¨è¨ˆ |
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CNS 13643
2018 Edition Biological evaluation of Dental Materials 牙科æ料之生物評估 |
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CNS 14393-11
2018 Edition Biological evaluation of medical devices - Part 11: Tests for systemic toxicity 醫療器æ生物性評估ï¼ç¬¬ï¼‘１部：全身毒性測試 |
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