UNE - Spanish national standards

Manufacturing by additive of caps on plastics. Additive manufacturing. Preparation of test pieces

Available languages: Spanish

Available design: electronic design (pdf), Print design

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

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

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

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

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

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

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

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/Amd1:2026) (Endorsed by Asociación Espanola de Normalización in June of 2026.)

Available languages: English

Available design: electronic design (pdf), Print design

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