GOST IEC 60601-1-8-2011 Medical electrical equipment Part 1-8 General requirements for safety General requirements tests and guidance for alarm systems in medical electrical equipm.pdf

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1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 1-8 , (IEC 60601-1-8:2003, IDT) 2013 IEC 60601-1-8 2011 IEC 60601-1-82011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 . ) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU 5 13 2011 . 1326- IEC 60601-1-820

2、11 1 2013 . 4 IEC 60601-1-8:2003 Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ( . 1-8. . . , ). . (IDT). 60601-1-82007 6 ( ) . , .

3、C, 2013 , IEC 60601-1-82011 III IEC 60601-1-8:2003 . 1-8. . . , (IEC 60601-1-8:2003 Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems1),

4、 62 62 3 121 . IEC 60601-1 () (). . , . . , , . , . , . . , , 1) . , 1.0, 1.1 1.2 , 1 1 2. IEC 60601-1-82011 IV . , , . IEC 60601-1 . 1. .1) : ISO 9703-1 . 1. ISO 9703-2 . 2. ISO 9703-3 . 3. , . , , , , 201; , ., aaa), bbb) . : - , , , , ; - ; - , 2 , , . . , , *. 1) 1 1997 . 60000. , IEC 601-1 IEC

5、60601-1. IEC 60601-1-82011 1 1-8 , Medical electrical equipment. Part 1-8. General requirements for safety. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical 2013-01-01 . 1* 1.201 . . 1.202 , . , , . IEC 60601-1-82011 2 . IEC 60513:1994

6、 4. : - , , - , - , - . 1.203 1.203.1 IEC 60601-1 IEC 60601-1-8 IEC 60601-1 . IEC 60601-1 , , : - IEC 60601-1; - IEC 60601-1-8; - . 1.203.2 . 1.203.3 . . ( ). IEC 60601-1-82011 3IEC 60417-DB:2000-101) Graphical symbols for use on equipment ( , ) IEC 60601-1:1998 Medical electrical equipment Part 1:

7、General requirements for safety ( . 1. ) IEC 60601-1-1:2000 Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: safety requirements for medical electrical systems ( . 1-1. . . ) IEC 60601-1-6:2004 Medical electrical equipment - Part 1-6: General requirements f

8、or safety - Collateral standard: Usability ( . 1-6. . . ) IEC 60651:19792)Sound level meters ( ) ISO 3744:1994 Acoustics Dermination of sound power levels of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane (. . ) ISO 7000:1989 Graphical symb

9、ols for use on equipment Index and synopsis ( , . ) 2 3). 1)DB - - . 2) ( 1.2), IEC 60651 (1997) 1 (1993) 2 (2000). 3). . IEC 60601-1-82011 4 . 2.201* (ALARM CONDITION): , . 1 , . . 2 , . . 2.202* (ALARM CONDITION DELAY): , , . , , . , , . 2.203* (ALARM LIMIT): , . 2.204 (ALARM OFF): , . 2.205* (ALARM PAUSED): , . 2.206 (ALARM PRESET): , , . IEC 60601-1-82011 52.207 (ALARM RESET): , , . 2.208 (ALARM SETTINGS): , ( ): - ; - ; - , . , . 2.209 (ALARM SIGNAL): , ( ) . 2.210* (ALARM SIGNAL GENERATION DELAY):