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UNE - Spanish national standards
Page 179
UNE-EN ISO 11607-1:2020 (23/09/2020)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 2 602.70 CZK more info
UNE-EN ISO 11607-1:2020/A1:2024 (22/05/2024) Change
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 1 981.30 CZK more info
UNE-EN ISO 11607-1:2020/A11:2022 (21/12/2022) Change
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 1 408.60 CZK more info
UNE-EN ISO 11607-2:2020 (23/09/2020)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 1 671.80 CZK more info
UNE-EN ISO 11607-2:2020/A1:2024 (22/05/2024) Change
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 1 696.20 CZK more info
UNE-EN ISO 11607-2:2020/A11:2022 (21/12/2022) Change
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Available languages: English, Spanish
Available design: electronic design (pdf), Print design
from 1 408.60 CZK more info
UNE-EN ISO 11608-1:2022 (01/07/2022)
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022) (Endorsed by Asociación Espanola de Normalización in July of 2022.)
Available languages: English
Available design: electronic design (pdf), Print design
from 2 936.60 CZK more info
UNE-EN ISO 11608-2:2022 (01/07/2022)
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022) (Endorsed by Asociación Espanola de Normalización in July of 2022.)
Available languages: English
Available design: electronic design (pdf), Print design
from 1 935.00 CZK more info
UNE-EN ISO 11608-3:2022 (01/07/2022)
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)
Available languages: English
Available design: electronic design (pdf), Print design
from 1 861.90 CZK more info
UNE-EN ISO 11608-4:2022 (01/07/2022)
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022, Corrected version 2024-12)
Available languages: English
Available design: electronic design (pdf), Print design
from 2 795.20 CZK more info
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