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>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.25 Syringes, needles and catheters>BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods Automated functions
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immediate downloadReleased: 2012-10-31
BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods Automated functions

BS EN ISO 11608-5:2012

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

CURRENCY
249.6 EUR
Standard number:BS EN ISO 11608-5:2012
Pages:26
Released:2012-10-31
ISBN:978 0 580 69949 8
Status:Standard
DESCRIPTION

BS EN ISO 11608-5:2012


This standard BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:
  • 11.040.25 Syringes, needles and catheters

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.