1 Scope
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:
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a) drug product preparation (e.g. reconstitution);
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b) needle preparation;
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c) air removal;
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d) priming;
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e) dose setting;
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f) actuation;
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g) needle insertion;
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h) injection of the medicinal product;
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i) disabling the NIS-AUTO;
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j) needle retraction;
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k) needle shielding;
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l) needle hiding;
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m) sharps injury protection;
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n) needle removal.