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Standards ÖNORM - Austrian standards - Page 134
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 11607-1
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) (consolidated version)
Standard published on 1.12.2022
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ÖNORM EN ISO 11607-1/A1
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019/Amd 1:2023) (Amendment)
Change published on 15.3.2024
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ÖNORM EN ISO 11607-2
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) (consolidated version)
Standard published on 1.12.2022
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ÖNORM EN ISO 11607-2/A1
Change
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019/Amd 1:2023) (Amendment)
Change published on 15.3.2024
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ÖNORM EN ISO 11608-1
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Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022)
Standard published on 15.10.2022
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ÖNORM EN ISO 11608-2
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Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022)
Standard published on 15.10.2022
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ÖNORM EN ISO 11608-3
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Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
Standard published on 1.1.2024
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ÖNORM EN ISO 11608-4
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Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
Standard published on 15.10.2022
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ÖNORM EN ISO 11608-5
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Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
Standard published on 15.7.2023
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ÖNORM EN ISO 11608-7
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Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
Standard published on 15.11.2017
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