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

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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 . .

4、, 1 , , , . , , (). , , , , , . , , , , . 3 : 3.1 (delivery system): , , . 3.2 (dynamic viscosity): , . 1 , . 2 . 3 . 4 . 3.3 (interfacial tension): , . (/). 3.4 (kinematic viscosity): . (2 /). 550382012 3 3.5 (non-solid implants): , , . 3.6 (surface tension): , , . (/). 3.7 (vapour pressure): , . (

5、 . .) (35 2) C. 3.8 (ocular endotamponades): , , / , , , . , , , , , . 3.9 (density): . 3.10 - (chain-length distribution): . - , , , . 3.11 () (historical or nonconcurrent control): , . 4 4.1 4.1.1 14630. : - ; - ; - . 4.1.2 , , . 4.2 4.2.1 4.2.1.1 14630. 4.2.1.2 , , , , . . , / . 4.2.2 . , . 550382012 4 , , , , , . , . . . 4.2.3 . , , , . , , , . . , . 4.2.4 . . 4.2.5

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