GOST R ISO 15223-1-2014 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements《医疗器械 用于医疗器械标签、 标记和提供信息的符号.pdf

1、 15223-1 2014 , , 1 ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements (IDT) 2015 15223-12014 II 1 ( ) , 4 2 436 - 3 04 2014 . 499- 4 15223-1:2012 -. , , - . 1. (ISO 15223-1:2012, Medical devices Symbo

2、ls to be used with medical device labels, labelling, and information to be supplied Part 1: Gen-eral requirements) - - , - 5 15223-12010 1.02012 ( 8). ( 1 ) , - . () - - . , (gost.ru) , 2015 -, - 15223-12014 III 1 . 1 2 . 1 3 . 1 4 2 4.1 , 2 4.2 . 2 4.3 3 5 . 3 () 24 () 28 () 29 .30 15223-12014 IV ,

3、 , . . - , . , . , . - , , , . , , , , . - , . , , - /T 210 . 15223-2 . , , - . : - ; - , , , ; - , ; - , , - , , - , , ; - , , . 15223-1:2007 980:2008, , . - , 15223-1 980, . - , , - - . 15223-12014 1 , , 1 Medical devices. Symbols to be used with medical device labels, labelling, and information t

4、o be supplied. Part 1. General requirements 20150601 1 , - , - . , - . , , , , , . , () . - , . 2 . 7000 , . (ISO 7000, Graphical symbols for use on equipment Index and synopsis) 8601 . (ISO 8601, Data elements and inter-change formats Information interchange Representation of dates and times) 14971

5、 . (ISO 14971, Medical devices Application of risk management to medical devices) 15223-2 . , , . 2. , (ISO 15223-2, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 2: Symbol development, selection and validation) 3 14971, - : 15223-12014

6、2 3.1 (characteristic information): . 3.2 (description): , - , . 3.3 (label): , , - . GHTF/SG1/N43:2005. 3.4 (labeling): , , - , . 1 , - . 2 , - , , . 3.5 , (symbol used in medical device labelling): () / - , . , -, , , - . 3.6 (title): , . 80416-1:2008, 3.9. 4 4.1 , , , 15223-2 . , , . 4.2 , , - ,

7、, , 1. , 7000, -, 7000, , , () - . 1 () - () , , 7000 60417. , - ( ), GIF PDF . - . - , - . , . 15223-12014 3 2 - , 1, -. , . - B. , - , . 3 . 14971. . - , , , . , -, , 8601. 4.3 , . , , . . 5 , , , , - , 1. , - . 1 -. , , . -, , . . 1, , - 70005.15.1.1 -, - - 90/385/EEC, 93/42/EEC98/79/EC-, , (. - ,- - ).98/79 ,