April 23, 2018
Labeling of active medical devices
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. |  |
AC current | GOST R IEC 60601-1 |
| 3. |  |
DC current | GOST R IEC 60601-1 |
| 4. |  |
AC and DC current in the same time | GOST R IEC 60601-1 |
| 5. |  |
3 phase alternating current | GOST R IEC 60601-1 |
| 6. |  |
3 phase alternating current with ground | GOST R IEC 60601-1 |
| 7. |  |
Protective ground | GOST R IEC 60601-1 |
| 8. |  |
Ground | GOST R IEC 60601-1 |
| 9. |  |
Equipotential earthing | GOST R IEC 60601-1 |
| 10. |  |
Electrical safety class II | GOST R IEC 60601-1 |
| 11. |  |
Careful! Refer the User Manual | GOST R IEC 60601-1 |
| 12. |  |
Refer the User Manual | GOST R IEC 60601-1 |
| 13. |  |
Status “ON” | GOST R IEC 60601-1 |
| 14. |  |
Status “OFF” | GOST R IEC 60601-1 |
| 15. |  |
Switcher “ON/OFF” with fixing state | GOST R IEC 60601-1 |
| 16. |  |
Button with “OFF” state in unpressed condition | GOST R IEC 60601-1 |
| 17. |  |
State “ON” power of device part | GOST R IEC 60601-1 |
| 18. |  |
State “OFF” power of device part | GOST R IEC 60601-1 |
| 19. |  |
Emergency stop | GOST R IEC 60601-1 |
| 20. |  |
Type B applied part | GOST R IEC 60601-1 |
| 21. |  |
Type BF applied part | GOST R IEC 60601-1 |
| 22. |  |
Type CF applied part | GOST R IEC 60601-1 |
| 23. |  |
AP category device | GOST R IEC 60601-1 |
| 24. |  |
APG category device | GOST R IEC 60601-1 |
| 25. |  |
Dangerous voltage | GOST R IEC 60601-1 |
| 26. |  |
Type B applied part with protection against defibrillator discharge | GOST R IEC 60601-1 |
| 27. |  |
Type BF applied part with protection against defibrillator discharge | GOST R IEC 60601-1 |
| 28. |  |
Type CF applied part with protection against defibrillator discharge | GOST R IEC 60601-1 |
| 29. |  |
Don’t use twice | GOST R IEC 60601-1 |
| 30. |  |
Safety symbols template | GOST R IEC 60601-1 |
| 31. |  |
Common precaution symbol | GOST R IEC 60601-1 |
| 32. |  |
Caution! High Voltage! | GOST R IEC 60601-1 |
| 33. |  |
Common prohibition symbol | GOST R IEC 60601-1 |
| 34. |  |
Don’t push | GOST R IEC 60601-1 |
| 35. |  |
Don’t seat | GOST R IEC 60601-1 |
| 36. |  |
Don’t tread on surface | GOST R IEC 60601-1 |
| 37. |  |
Template for symbols of necessary actions | GOST R IEC 60601-1 |
| 38. |  |
Common symbol of necessary actions | GOST R IEC 60601-1 |
| 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.
