Medical device labeling

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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.  1 Manufacturer GOST R 50444, GOST R ISO 15223, GOST 14192
2.  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. 4 Lot number GOST R 50444, GOST R ISO 15223, GOST 14192
5.  5 Reference number GOST R 50444, GOST R ISO 15223
6. 6 Serial number GOST R 50444, GOST R ISO 15223, GOST 14192
7.  7 Use before (month and year) GOST R ISO 15223
Sterility
8.  8 Sterile GOST R 50444, GOST R ISO 15223
9.  9 Steriled by aseptic process GOST R 50444, GOST R ISO 15223
10.  10 Steriled by ethylene oxide GOST R 50444, GOST R ISO 15223
11.  11 Steriled by irradiation GOST R 50444, GOST R ISO 15223
12.  12 Steriled by steam or heat GOST R 50444, GOST R ISO 15223
13.  13 Don’t sterilize twice GOST R ISO 15223
14.  14 Non sterile GOST R ISO 15223
15.  15 Don’t use if package is damaged GOST R ISO 15223
16.  16 Contains sterile liquid GOST R ISO 15223
Storage
17.  17 Fragile, take care GOST R ISO 15223, GOST 14192
18.  18 Protect against sun light GOST R ISO 15223, GOST 14192
19.  19 Protect against heat and radioactive irradiation GOST R ISO 15223
20.  20 Protect against moisture GOST R ISO 15223
21.  21 Low limit of temperature range GOST R ISO 15223
22.  22 High limit of temperature range GOST R ISO 15223
23.  23 Temperature range GOST R ISO 15223, GOST 14192
24.  24 Humidity range GOST R ISO 15223
25.  25 Pressure range GOST R ISO 15223
Safety use
26.  26 Bio hazard GOST R ISO 15223
27.  27 Don’t use twice GOST R ISO 15223
28.  28 Refer the instruction GOST R ISO 15223
29.  29 Careful! Refer the instruction GOST R ISO 15223
30.  30 Contains natural latex GOST R ISO 15223
IVD devices
31.  31 In vitro device GOST R ISO 15223
32.  32 Control material GOST R ISO 15223
33.  33 Negative control material GOST R ISO 15223
34.  34 Positive control material GOST R ISO 15223
35.  35 Enough for N tests GOST R ISO 15223
36.  36 For functional characteristics evaluation only GOST R ISO 15223
Infusion/transfusion devices
37.  37 Sample place GOST R ISO 15223
38.  38 Contains liquid GOST R ISO 15223
39. 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.  41 Number of drops in 1 ml of liquid GOST R ISO 15223
42. 42 Filter for liquids with defined size of pores GOST R ISO 15223
43. 43 One directional valve GOST R ISO 15223
Other
44.  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.  1-1 Fragile, take care GOST 14192
2.  2-1 Protect against sun light GOST 14192
3.  3-1 Protect against radioactive irradiation GOST 14192
4. 4-1 Protect against moisture GOST 14192
5. 5-1 Protect against irradiation GOST 14192
6.  6-1 This side up GOST 14192
7.  7-1 Don’t stockpile GOST 14192
8.  8-1 Maximal mass of upper boxes in stack GOST 14192
9.  9-1 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.

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