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  • BSI
    20/30382355 DC BS EN ISO 11608-5. Needle-based injection systems for medical use. Requirements and test methods - Part 5. Automated functions
    Edition: 2020
    $44.66
    / user per year

Description of 20/30382355 DC 2020

This document specifies requirements and test methods for needle-based injection systems with automated functions (NIS-AUTO), including but not limited to:

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

  2. needle preparation;

  3. needle hiding;

  4. priming;

  5. dose setting;

  6. needle insertion;

  7. injection depth control;

  8. injection of the medicinal product;

  9. recording;

  10. disabling the NIS-AUTO;

  11. needle retraction;

  12. needle shielding;

  13. needle removal.

This document does not cover remote communication from the NIS-AUTO.

Automated features not included in the list above shall be specified and tested in accordance with the principles of this document.

All references to "function" in this document are by definition to be construed as automated functions (see 3.2). This document does not apply to these functions if they are performed manually by the user.



Standard Number20/30382355 DC
TitleBS EN ISO 11608-5. Needle-based injection systems for medical use. Requirements and test methods - Part 5. Automated functions
StatusDefinitive
Publication Date2020-02-26
Identical National Standard OfISO/DIS 11608-5
DescriptorsMedical equipment, Syringes, Drug administration, Performance testing, Performance, Parenteral infusion equipment, Electrical medical equipment, Medical instruments, Injection instruments, Injection guns
ICS11.040.25 Syringes, needles and catheters, 11.040.25 Syringes, needles and catheters
CommitteeCH/84
PublisherBSI
Pages29

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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