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ÖNORM - Austrian standards
Page 96
ÖNORM EN ISO 10993-18/A1 (15/02/2024) Change
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020/Amd 1:2022) (Amendment)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 90.00 USD more info
ÖNORM EN ISO 10993-2 (01/04/2023)
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 85.30 USD more info
ÖNORM EN ISO 10993-23 (15/09/2021)
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Available languages: English
Available design: electronic design (pdf), Print design
from 208.70 USD more info
ÖNORM EN ISO 10993-23/A1 (15/01/2026) Change
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/Amd 1:2025)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 105.70 USD more info
ÖNORM EN ISO 10993-3 (01/01/2015)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 162.30 USD more info
ÖNORM EN ISO 10993-4 (01/01/2018)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 295.90 USD more info
ÖNORM EN ISO 10993-4/A1 (01/07/2025) Change
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 105.70 USD more info
ÖNORM EN ISO 10993-5 (01/12/2009)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 175.50 USD more info
ÖNORM EN ISO 10993-5/A11 (01/05/2025) Change
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Available languages: English, German
Available design: electronic design (pdf), Print design
from 73.10 USD more info
ÖNORM EN ISO 10993-6 (01/08/2026)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2026)
Available languages: English, German
Available design: electronic design (pdf), Print design
from 232.90 USD more info
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