April 6, 2018
Medical device labeling
Today we speak about some easy but necessary rules in Russia - labeling, marking of medical devices must comply with in order to medical device could be registered in Russian Federation.
Should be noticed, that all the labeling rules (except the electrotechnical symbols) are regulated by 3 standards: GOST R 50444, GOST R ISO 15223 and GOST 14192. The last one regulates cargo labeling.
In other words, medical device labeling must contain applicable symbols from these standards. Below you can se useful table, containing necessary symbols with it’s documental references.
Table 1. – Necessary symbols for medical device labeling.
| All devices | |||
| # | Symbol | Description | Source standard |
| Manufacturing | |||
| 1. |  |
Manufacturer | GOST R 50444, GOST R ISO 15223, GOST 14192 |
| 2. |  |
Manufacturing date (month and year) | GOST R 50444, GOST R ISO 15223, GOST 14192 |
| 3. | Model | Device model | GOST R 50444, GOST R ISO 15223, GOST 14192 |
| 4. |  |
Lot number | GOST R 50444, GOST R ISO 15223, GOST 14192 |
| 5. |  |
Reference number | GOST R 50444, GOST R ISO 15223 |
| 6. |  |
Serial number | GOST R 50444, GOST R ISO 15223, GOST 14192 |
| 7. |  |
Use before (month and year) | GOST R ISO 15223 |
| Sterility | |||
| 8. |  |
Sterile | GOST R 50444, GOST R ISO 15223 |
| 9. |  |
Steriled by aseptic process | GOST R 50444, GOST R ISO 15223 |
| 10. |  |
Steriled by ethylene oxide | GOST R 50444, GOST R ISO 15223 |
| 11. |  |
Steriled by irradiation | GOST R 50444, GOST R ISO 15223 |
| 12. |  |
Steriled by steam or heat | GOST R 50444, GOST R ISO 15223 |
| 13. |  |
Don’t sterilize twice | GOST R ISO 15223 |
| 14. |  |
Non sterile | GOST R ISO 15223 |
| 15. |  |
Don’t use if package is damaged | GOST R ISO 15223 |
| 16. |  |
Contains sterile liquid | GOST R ISO 15223 |
| Storage | |||
| 17. |  |
Fragile, take care | GOST R ISO 15223, GOST 14192 |
| 18. |  |
Protect against sun light | GOST R ISO 15223, GOST 14192 |
| 19. |  |
Protect against heat and radioactive irradiation | GOST R ISO 15223 |
| 20. |  |
Protect against moisture | GOST R ISO 15223 |
| 21. |  |
Low limit of temperature range | GOST R ISO 15223 |
| 22. |  |
High limit of temperature range | GOST R ISO 15223 |
| 23. |  |
Temperature range | GOST R ISO 15223, GOST 14192 |
| 24. |  |
Humidity range | GOST R ISO 15223 |
| 25. |  |
Pressure range | GOST R ISO 15223 |
| Safety use | |||
| 26. |  |
Bio hazard | GOST R ISO 15223 |
| 27. |  |
Don’t use twice | GOST R ISO 15223 |
| 28. |  |
Refer the instruction | GOST R ISO 15223 |
| 29. |  |
Careful! Refer the instruction | GOST R ISO 15223 |
| 30. |  |
Contains natural latex | GOST R ISO 15223 |
| IVD devices | |||
| 31. |  |
In vitro device | GOST R ISO 15223 |
| 32. |  |
Control material | GOST R ISO 15223 |
| 33. |  |
Negative control material | GOST R ISO 15223 |
| 34. |  |
Positive control material | GOST R ISO 15223 |
| 35. |  |
Enough for N tests | GOST R ISO 15223 |
| 36. |  |
For functional characteristics evaluation only | GOST R ISO 15223 |
| Infusion/transfusion devices | |||
| 37. |  |
Sample place | GOST R ISO 15223 |
| 38. |  |
Contains liquid | GOST R ISO 15223 |
| 39. |  |
Apyrogenous
(ALSO NECESSARY FOR IMPLANTABLE DEVICES!) |
GOST R 50444, GOST R ISO 15223 |
| 40. | Нетоксично | Non-toxic | GOST R 50444, GOST R ISO 15223 |
| 41. |  |
Number of drops in 1 ml of liquid | GOST R ISO 15223 |
| 42. |  |
Filter for liquids with defined size of pores | GOST R ISO 15223 |
| 43. |  |
One directional valve | GOST R ISO 15223 |
| Other | |||
| 44. |  |
Patient number | GOST R ISO 15223 |
Necessary symbols for transportation boxes - in table 2.
Table 2. –Necessary symbols for transportation boxes
| # | Symbol | Description | Source standard |
| 1. |  |
Fragile, take care | GOST 14192 |
| 2. |  |
Protect against sun light | GOST 14192 |
| 3. |  |
Protect against radioactive irradiation | GOST 14192 |
| 4. |  |
Protect against moisture | GOST 14192 |
| 5. |  |
Protect against irradiation | GOST 14192 |
| 6. |  |
This side up | GOST 14192 |
| 7. |  |
Don’t stockpile | GOST 14192 |
| 8. |  |
Maximal mass of upper boxes in stack | GOST 14192 |
| 9. |  |
Maximal number of upper boxes in stack | GOST 14192 |
We hope, that this information will help you to make correct marking for state registration of your device.
