1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) ISO 8009 2013 (ISO 8009:2004, IDT) ISO 80092013 II , 1.092 . 1.22009 . , . , , , 1 - ( ), 160 , 4 2 3 , ( 28 2013 . 58-) : ( 3166) 00497 ( 3166) 00497 AZ AM BY KG MD - RU TJ UZ 4 ISO 8009:2004 Mechanical contraceptives R
2、eusable natural and silicone rubber contraceptive diaphragms Requirements and tests ( . . ). ISO/TC 157 (ISO). (en). 1.52001 (. 3.6). , , , , . . (IDT) 5 28 2013 . 759- ISO 80092013 01 2015 . 6 ISO 80092013 III , . () . , , 2014 , ISO 80092013 IV . , , ISO 9000, ISO 13485 ISO 14386. (AQL), , . (AQL)
3、 . , . . . ISO 8009 2013 1 Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. General requirements and tests 2015 01 01 1 1 , . . , , . 2 . . ISO 188:2011 Rubber, vulcanized or thermoplastic Accelerated ageing and heat resistance tests ( . ) ISO 463:2006 Geomet
4、rical product specification (GPS) Dimensional measuring equipment Design and metrological characteristics of mechanical dial gauges (GPS). . ISO 2859-1:1999 Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection .
5、 1. (AQL) ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxity ( . 5. in vitro) ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delaedtype hypersensitivity ( . 10. ) 3 : 3.1 (lot, batch): , , , , , , , . , . . .
6、ISO 80092013 2 4 ISO 2858-1. ISO 2859-1. , . 5 : ) 1 ; b) 2 ( ); c) 3 . 6 , , . ISO 10993-5 , , . , . ISO 10993-10 , , . , , , . ISO 10993-5 ISO 10993-10 . 7 7.1 . . 7.2 , . 7.3 . 7.4 , . 7.5 , . ISO 80092013 3 8. 8.1 55; 60; 65; 70; 75; 80; 85; 90; 95 100 . A 4%. -, 2 . 13 . . 8.2 B 0,20 . 9 - 9.1
7、C , 13 , , 1. D 13 , 1. 9.2 C 13 , 1. D 13 , 1. 1 - , Ma, 15 11 7 7 - , %, 650 500 350 350 10 - ( - 1 2) 10.1 13 E 1- 1000- 55% 85% . ISO 80092013 4 , 1000- -, 90% , . 1000- . 1000- , - F, 20. , ISO 9000 , - . . 10.2 F - 20. ISO 2859-1 1, . F AQL 1,0%. 11 . ISO 2859-1 1, . (AQL) 0,4% : a) ; b) ; c) ; d) ; e) ; f) . G (AQL) 1,0%. 12 H. 13 , 13.1 13.1.1 , , . 13.1.2 - , . . 13.2 13.2.1 , : ) ; b) , . ISO 80092013 5 13.2.2 , : ) ; b) ; ) , ; d) ( ), , . -
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