GOST - Russian national standards

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GOST ISO 10993-13-2016 (1.10.2017)

GOST ISO 10993-13-2016 (01/10/2017)

Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 93.60 USD more info
GOST ISO 10993-14-2011 (1.1.2013)

GOST ISO 10993-14-2011 (01/01/2013)

Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 106.60 USD more info
GOST ISO 10993-15-2023 (1.6.2024)

GOST ISO 10993-15-2023 (01/06/2024)

Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 93.60 USD more info
GOST ISO 10993-16-2021 (1.3.2022)

GOST ISO 10993-16-2021 (01/03/2022)

Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 91.00 USD more info
GOST ISO 10993-18-2022 (1.7.2023)

GOST ISO 10993-18-2022 (01/07/2023)

Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 198.90 USD more info
GOST ISO/TS 10993-19-2024 (12.7.2025)

GOST ISO/TS 10993-19-2024 (12/07/2025)

Medical devices. Biological evaluation of medical devices. Part 19. Physico-chemical, morphological and topographical characterization of materials

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 93.60 USD more info
GOST ISO 10993-2-2025 (1.1.2026)

GOST ISO 10993-2-2025 (01/01/2026)

Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements

Available languages: English and Russian, Russian

Available design: electronic design (pdf), Print design

from 93.60 USD more info
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 93.60 USD 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 188.50 USD 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 185.90 USD more info
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