Standard name: Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems (ISO 11608-1:2022)
Applicable medical devices:
This standard applies to systems intended for use with needles and either replaceable or non-replaceable containers. The containers covered by the standard can be single or multi-dose syringe-based and cartridge-based systems – filled either by the manufacturer or by the user.
Testing capabilities to ISO 11608-1 include:
- Dose accuracy as defined by design specifications of the NIS
- Preparation and operation of needle-based injection systems
- Cool, standard and warm atmosphere testing
- Last dose accuracy
- Life-cycle testing
- Free-fall testing
- Dry-heat and cold-storage testing
- Damp-heat testing
- Cyclical testing
- Vibration testing
- Visual Inspection of NIS and container
- Flow rate through the needle
- Bond between hub and needle tube
- Ease of assembly with containers and needles
- Automated function – needle hiding and shielding, insertion distance, retraction and minimum overriding forces.
Other ISO 11608 Sections include:
- ISO 11608-2: 2022 Needles
- ISO 11608-3: 2022 Finished containers
- ISO 11608-4: 2022 Electronic and electromechanical pen-injectors
- ISO 11608-5: 2022 Automated functions
Part 2, 3 and 5 of ISO 11608 series specifies common test methods to support performance requirements for sterile double-ended needles and containers intended for use in conjunction with needle-based injection systems and the automated function of NISs.
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.
Please note: The information outlined above is to be used as a reference. Please refer to the appropriate competent standards agency in your country for full details and implementation of EN ISO 11608-1:2022.
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