Needle-based injection systems (NISs), or auto injectors, are used in a wide variety of applications where a drug or biologic product needs to be delivered via injection – typically either subcutaneously or intramuscularly. The performance requirements for injector pens and needles as defined in the ISO 11608 standard must be met before products can be brought to market.
ISO 11608 specifies requirements and test methods for needle-based injection systems intended to be used with needles and with replaceable or non-replaceable containers. ISO 11608 is comprised of seven parts. DDL is able to carry out testing for the following parts of the ISO 11608:
- ISO 11608-1 — Part 1: Needle-based injection systems
- ISO 11608-2 — Part 2: Needles
- ISO 11608-3 — Part 3: Finished Containers
- ISO 11608-5 — Part 5: Automated Functions
DDL also offers ISO 23908 – sharps injury testing in conjunction with ISO 11608 testing.
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