GOST R 55038-2012 Ophthalmic optics Ophthalmic implants Ocular endotamponades General safety requirements《眼科光学 眼科植入物 眼球内压塞 通用安全要求》.pdf

1、 55038 2012 ( 16672:2003) ISO 16672:2003 Ophthalmic implants Ocular endotamponades (MOD) 550382012 II 1 7 296 , 4 2 3 01 2012 . 685- 4 16672:2003 . (ISO 16672:2003 Ophthalmic implants Ocular endotamponades) : - . 1.5 2004 ( 3.5); - . ; - , ; - , ; - , . , . , 5 1.02012 ( 8). ( 1 ) , . () . , (gost.r

2、u) , 2015 , 550382012 ( 16672:2003) 1 . Ophthalmic optics. Ophthalmic implants. Ocular endotamponades. General safety requirements 2014 07 01 1 ( ) , . . , , , , , . 2 : 10993-12009 . . 1. 10993-22009 . . 2. 10993-32009 . . 3. , 10993-52009 . . 5. : in vitro 10993-62009 . . 6. 10993-72009 . . 7. 109

3、93-102009 . . 10. 111342000 . . 111352000 . 13408-12011 . 1. 14155-12008 . 1. 14155-22008 . 2. 550382012 2 146302011 . 149712009 . 15223-12010 . , , . 1. 5114898 . , , - , 516092000 . . 524582005 ( 11979-7:2001) . . 7. ISO 11137-12011 . . , ISO 11137-22011 . . 2. ISO 116072011 , . ISO 134852011 . .

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