1、 (ISO 23409:2011, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 234092014, - 1.092 . 1.22009 . -, . , , 1 - , , ( ), 160 - 5 - , 2 (-)3 , ( 14 2014 . 72-) : ( 3166) 00497 ( 3166) 00497 AMBYKZKGMDRUTJ -4 20 2015 . 382- ISO 234092014 1 2016 .5 ISO 23409:2011 Male
2、 condoms Requirements and test methods for condoms made from synthetic materials ( . - ). ISO/TC 157 - , - (ISO). (en). - 1.52001 ( 3.6). , - , , , . - . (IDT)6 II ISO 234092014 -, - . () . , - - , 2015 -, III ISO 2340920141 .12 13 24 35 36 47 48 49 .510 ( ) .511 612 613 614 , 715 716 .717 9 () .11
3、() , - .12 () .13 D () .14 () 16 F () 17 G () . . 18 () .21 I () .23 J () 26 K () - 30 L () .32 () 34 N () 3536 () .38IV ISO 234092014 ( ) . (), () , () (HIV), , (STI), . STI , , ,.- . . , , , - , , - , , (), . . - , , - (. ISO 14971, 4 8, 9). , -. : , , , , , , , , , , , , - . , , -.- .V ISO 234092
4、014 Male condoms made from synthetic materials.Requirements and test methods1 , , (STI), - .2 . -().ISO 2859-1 Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed byacceptance quality limit (AQL) for lot-by-lot inspection . 1. (AQL) ISO 4074 Natural latex rubber condoms
5、 Requirements and test methods ( - . )ISO/TR 8550 (all parts) Guidance on the selection and usage of acceptance sampling systems forinspection of discrete items in lots - ( )ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a riskmanagement process ( . 1. - )
6、ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity (- . 5. in vitro)ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and skinsensitization(.10.- )ISO 14155 Clinical investigation of medical devices for human subjects Good c
7、linical practice (- . )ISO 14971 Medical devices Application of risk management to medical devices ( -. )ISO 15223 (all parts) Medical devices Symbols to be used with medical device labels, labeling, andinformationtobesupplied.,- ( )ISO 16037 Rubber condoms for clinical trials Measurement of physica
8、l properties ( . )1 ISO 234092014 201607013 :3.1 ; AQL (acceptance quality limit): -, (ISO 2859, 3.1.26.3.2 (male condom): , , - , (STI). (, . .), , .3.3 (consumer package): , , .3.4 (expiry date): , -.3.5 (identification number): , , , , . , - . - , , , - .3.6 (individual container): , -.3.7 (inspection level): . . ISO 2859-1 ( 10.1).3.8 (lot): , , , , , , , , - .3.9 (lot number): , , , .3.10 (lot test): . , .3.11 (non-visible hole): , ,- . .3.12 (sampling plan): , - , ( ), ( ).3.13 (shelf-life): , - , , - . .3.14 (synthetic material): , 100 %- ,
