DIN EN ISO 11608-3:2013 PDF

Scope: This part of ISO 11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the end-user integrated in the NIS or assembled with the NIS at the time of use.

DIN EN ISO 11608-3:2013 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 11040-3 Prefilled syringes - Part 3: Seals for dental local anaesthetic cartridges
ISO 11608-1 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems*， 2022-04-07 Update
ISO 11608-2 Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles*， 2022-04-07 Update
ISO 13926-1:2004 Pen systems - Part 1: Glass cylinders for pen-injectors for medical use

2024 DIN EN ISO 11608-3:2024-01 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); German version EN ISO 11608-3:2022
2022 DIN EN ISO 11608-3:2022-09 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022); German version EN ISO 11608-3:2022
2022 DIN EN ISO 11608-3:2022 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)
1970 DIN EN ISO 11608-3 E:2020-05 Medical Needle Injection Systems Requirements and Test Methods Part 3: Containers and Integrated Fluid Paths (Draft)
2020 DIN EN ISO 11608-3 E:2020 Draft Document - Needle-based injection systems for medical use - Requirements and test methods - Part 3: NIS containers and integrated fluid paths (ISO/DIS 11608-3:2020); German and English version prEN ISO 11608-3:2020
2013 DIN EN ISO 11608-3:2013 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012); German version EN ISO 11608-3:2012
2000 DIN EN ISO 11608-3:2001 Pen injectors for medical use – Part 3: Finished cartridges – Requirements and test methods