ISO-8871-5 › Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
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ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
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Oct. 15, 2016