GOST - Russian national standards

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GOST ISO/TS 10993-20-2011 (1.1.2013)

GOST ISO/TS 10993-20-2011 (01/01/2013)

Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 80.70 EUR more info
GOST ISO/TR 10993-22-2020 (1.3.2021)

GOST ISO/TR 10993-22-2020 (01/03/2021)

Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 162.60 EUR more info
GOST ISO 10993-23-2023 (1.6.2024)

GOST ISO 10993-23-2023 (01/06/2024)

Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 160.40 EUR more info
GOST ISO 10993-3-2018 (1.6.2019)

GOST ISO 10993-3-2018 (01/06/2019)

Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 127.80 EUR more info
GOST ISO/TR 10993-33-2018 (1.6.2019)

GOST ISO/TR 10993-33-2018 (01/06/2019)

Medical devices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 145.80 EUR more info
GOST ISO 10993-4-2020 (1.3.2021)

GOST ISO 10993-4-2020 (01/03/2021)

Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 167.10 EUR more info
GOST ISO 10993-5-2023 (1.6.2024)

GOST ISO 10993-5-2023 (01/06/2024)

Medical devices. Biological evaluation of medical devices. Part 5. Cytotoxicity studies by in vitro methods

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 111.00 EUR more info
GOST ISO 10993-6-2021 (1.3.2022)

GOST ISO 10993-6-2021 (01/03/2022)

Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 115.50 EUR more info
GOST ISO 10993-7-2016 (1.10.2017)

GOST ISO 10993-7-2016 (01/10/2017)

Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 179.40 EUR more info
GOST ISO 10993-9-2022 (1.7.2023)

GOST ISO 10993-9-2022 (01/07/2023)

Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 69.50 EUR more info
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