Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems.

Standard published on 13.5.2026

Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes.

Standard published on 1.11.2023

Packaging for terminally sterilized medical devices. Requirements for process development for forming, sealing and assembly.

Standard published on 30.9.2026

Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems.

Standard published on 7.7.2026

Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles. Part 2: Needles.

Standard published on 15.7.2022

Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles.

Standard published on 12.8.2022

Needle-based injection systems for medical use. Requirements and test methods. Containers and integrated fluid paths.

Standard published on 29.4.2026

Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems containing electronics.

Standard published on 28.8.2025

Needle-based injection systems for medical use. Requirements and test methods. Automated functions.

Standard published on 28.3.2023

Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods. Automated functions.

Standard published on 13.4.2023