KS P ISO 14630-2009 Non-active surgical implants－General requirements《非活动外科植入物的通用要求》.pdf

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4、 2： KS P ISO 11607 1, 1： , KS P ISO 14155 1, 1： KS P ISO 14155 2, 2： KS P ISO 17665 1, , 1： , KS X ISO 8601, ISO 10993 7, Biological evaluation of medical devices Part 7： Ethylene oxide sterilization residuals KS P ISO 14630:2009 2 ISO 11135 1, Sterilization of health care products Ethylene oxide Pa

5、rt 1 ： Requirements for development, validation and routine control of a sterilization process for medical devices ISO 13408 1, Aseptic processing of health care products Part 1： General requirements ISO 14160, Sterilization of single use medical devices incorporating materials of animal originValid

6、ation and routine control of sterilization by liquid chemical sterilants ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Med

7、ical devices Application of risk management to medical devices ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 22442 1, Medical devices utilizing animal tissues and their derivatives Part 1： Applicati

8、on of risk management ISO 22442 2, Medical devices utilizing animal tissues and their derivatives Part 2： Controls on sourcing, collection and handling ISO 22442 3, Medical devices utilizing animal tissues and their derivatives Part 3： Validation of the elimination and/or inactivation of viruses and

9、 transmissible spongiform encephalopathy (TSE) agents 3 . 3.1 (coating) 3.2 (implantable state) 3.3 (leakage) . . 3.4 (magnetic resonance environment) MR (MR environment) (magnetic resonance imaging scanner) 3 , 0.50 mT (5 G) ASTM F2503 051), definition 3.1.7 0.50 mT Faraday shield , . , 0.50 mT Far

10、aday shield , . 1) ASTM , ASTM F2503 05 ASTM F2119 01 , ASTM International http:/www.astm.org/ .KS P ISO 14630:2009 3 3.5 (magnetic resonance imaging) MRI (static magnetic field) (time varying magnetic field) ASTM F2119 011), definition 2.1.4 3.6 (non-active surgical implant) 3.7 (safety) KS A ISO/I

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14、135 1 . KS P ISO 11137 1 KS P ISO 11137 2 . KS P ISO 17665 1 . ISO 14160 . ISO 14937 . KS P ISO 14630:2009 7 ISO 13408 1 . 9.3 9.3.1 , . (11. ). 9.3.2 , ISO 17664 . . 9.4 KS P ISO 10993 1 . ISO 10993 7 . 10 10.1 , ( , ) , . 1 EN 60068 2 27, EN 60068 2 32 EN 60068 2 47 (A.2 ). 2 . . 10.2 “ (STERILE)”

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16、00 2498 “LOT”, “SN”, d) , e) , 2 KS S ISO 7000 2499 “ (STERILE)” , KS S ISO 7000 2500, KS S ISO 7000 2501, KS S ISO 7000 2502 KS S ISO 7000 2503 “ ” KS P ISO 14630:2009 9 f) , , 3 KS S ISO 7000 2609 “ ” g) , “ ” 4 KS S ISO 7000 2607 “ ” h) 5 KS S ISO 7000 1051 “ ” i) / j) k) 11.3 , . a) , b) c) (： ), d) , e) 4. f) ( ) , g) , h) i) 1 KS S ISO 7000 2499 “ (STERILE)” , KS S ISO 7000 2500, KS S ISO 7000 2501, ISO 7000 2502 KS S ISO 7000 2503 “ ” j) , , k) 2 , , l) , m) 3 KS S ISO 7000 1051 “ ” n) / KS P ISO 14630:2009 10 o) (： )