Labeling of active medical devices

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In one of the previous articles we discussed necessary symbols, that must contain label of medical devices for state registration in Russia. Today we present symbols, that must contain label of active medical devices. They are presented in the Table 1.

Table 1 – Necessary symbols

Power source parameters
1. Power (I or P) Consuming current or power GOST R 50444
2.  2 AC current GOST R IEC 60601-1
3.  3 DC current GOST R IEC 60601-1
4.  4 AC and DC current in the same time GOST R IEC 60601-1
5.  5 3 phase alternating current GOST R IEC 60601-1
6.  6 3 phase alternating current with ground GOST R IEC 60601-1
7. 7 Protective ground GOST R IEC 60601-1
8.  8 Ground GOST R IEC 60601-1
9. 9 Equipotential earthing GOST R IEC 60601-1
10.  10 Electrical safety class II GOST R IEC 60601-1
11.  11 Careful! Refer the User Manual GOST R IEC 60601-1
12.  12 Refer the User Manual GOST R IEC 60601-1
13.  13 Status “ON” GOST R IEC 60601-1
14.  14 Status “OFF” GOST R IEC 60601-1
15.  15 Switcher “ON/OFF” with fixing state GOST R IEC 60601-1
16.  16 Button with “OFF” state in unpressed condition GOST R IEC 60601-1
17. 17 State “ON” power of device part GOST R IEC 60601-1
18.  18 State “OFF” power of device part GOST R IEC 60601-1
19.  19 Emergency stop GOST R IEC 60601-1
20.  20 Type B applied part GOST R IEC 60601-1
21.  21 Type BF applied part GOST R IEC 60601-1
22.  22 Type CF applied part GOST R IEC 60601-1
23. 23 AP category device GOST R IEC 60601-1
24.  24 APG category device GOST R IEC 60601-1
25.  25 Dangerous voltage GOST R IEC 60601-1
26.  26 Type B applied part with protection against defibrillator discharge GOST R IEC 60601-1
27.  27 Type BF applied part with protection against defibrillator discharge GOST R IEC 60601-1
28.  28 Type CF applied part with protection against defibrillator discharge GOST R IEC 60601-1
29.  29 Don’t use twice GOST R IEC 60601-1
30.  30 Safety symbols template GOST R IEC 60601-1
31.  31 Common precaution symbol GOST R IEC 60601-1
32.  32 Caution! High Voltage! GOST R IEC 60601-1
33.  33 Common prohibition symbol GOST R IEC 60601-1
34.  34 Don’t push GOST R IEC 60601-1
35.  35 Don’t seat GOST R IEC 60601-1
36.  36 Don’t tread on surface GOST R IEC 60601-1
37. 37 Template for symbols of necessary actions GOST R IEC 60601-1
38.  38 Common symbol of necessary actions GOST R IEC 60601-1
39.  39 Refer the User Manual GOST R IEC 60601-1
40. 50/60 Hz Frequency of AC power source GOST R IEC 60601-1

We hope, that this information will be useful for you.

 

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