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BS EN ISO 11608-5:2012

BS EN ISO 11608-5:2012

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

Published By Publication Date Number of Pages
BSI 2012 26
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This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans, including but not limited to:

  1. drug product preparation (e.g. reconstitution);

  2. needle preparation;

  3. air removal;

  4. priming;

  5. dose setting;

  6. actuation;

  7. needle insertion;

  8. injection of the medicinal product;

  9. disabling the NIS-AUTO;

  10. needle retraction;

  11. needle shielding;

  12. needle hiding;

  13. sharps injury protection;

  14. needle removal.

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BS EN ISO 11608-5:2012
$142.49