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Standards ÖNORM - Austrian standards - Page 95
In Austria, around 4,000 experts in active committees develop standards for the domestic, European and global market. They represent the interests of the economy, consumers, research, administration and society.
Together with them, Austrian Standards – the Austrian competence centre for standards – finds solutions ensuring that everything fits together perfectly and life runs smoothly. Austrian Standards distributes know-how laid down in standards as quickly as possible so that people and the economy can profit from it.
Austrian Standards, established in 1920, is structured in the business divisions of development, consulting, publishing, training and certification and finances the standardization system by more than 80 per cent through the sale of its products and services. Its legal basis is defined in the Standardization Act (Normengesetz 2016).
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ÖNORM EN ISO 10993-17
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Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
Standard published on 15.2.2024
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ÖNORM EN ISO 10993-18
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Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Standard published on 15.2.2021
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ÖNORM EN ISO 10993-18/A1
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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)
Change published on 15.2.2024
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ÖNORM EN ISO 10993-2
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Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Standard published on 1.4.2023
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ÖNORM EN ISO 10993-23
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Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Standard published on 15.9.2021
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ÖNORM EN ISO 10993-3
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Standard published on 1.1.2015
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ÖNORM EN ISO 10993-4
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Standard published on 1.1.2018
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ÖNORM EN ISO 10993-4/A1
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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)
Change published on 1.7.2025
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ÖNORM EN ISO 10993-5
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Standard published on 1.12.2009
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ÖNORM EN ISO 10993-5/A11
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Change published on 1.5.2025
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