1、 15223-2 2013 , , . 2 , ISO 15223-2:2010 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validation (IDT) 2014 15223-2:2013 II 1 , 4 2 436 3 8 2013 . 1489- 4 15223-2:2010 . , , . 2. , (ISO 15223-2:2010
2、 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validation) , 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 15223-2-2013 III 15223 , , . , . , . , . . , , , . , , . 15223-1 , , . , 15223-1, . /T
3、 210 . , , , , , , . , , . , , , . , , , . , , , . , , . , . , , . , 15223-1. , . / 210, , , , , 15223-1 : - ; - ; - , , . , , , , 15223-1 . 15223-1-2013 1 . , , 2 , Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2. Symbol development,
4、 selection and validation 20150101 1 , , 15223-1. , , 15223-1, . , , , , 4 10, , , . , , . 2 : 9186-1:2007 . . 1. 15223-1 . , , . 1. 80416-2 , . 2. 80416-1:2008 , . 1. , 1 , , , . , , (). , , , , , . , , , , . 3 . 15223-2-2013 2 3.1 (appropriateness ranking test): . 3.2 (associative strength test):
5、 3.3 (characteristic information): . 3.4 (comprehension test): , 9186-1, 3.1. 3.5 (description): , , . 80416-1, 3.2. 3.6 (symbol concept): , , . 3.7 (symbol original): , 80416-1 . 80416-1, 3.8. 3.8 , (symbol used in medical device labelling): () / , . , , , , - . 3.9 (title): , . 80416-1, 3.9. 3.10
6、 (target group): , , , , , , , , ( ). 3.11 (usability): , , , . 10. 4 4.1 : ) ; b) :- , () (), () ; - . 4.2 , . , . 15223-1. 15223-2-2013 3 4.3 , , . , , . . 15223-1. , /T 210, , 15223-1, . 5 15223-1 5.1 , /T 210 15223-1, , , . , 15223-1, 3 / 210 : symbolsinfoaami.org. . 1 , , , 1. 2 3 / 145 1, 3 6. 3 , 3 / 210 ( , 5.2), , . 5.2
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