DSF/PREN ISO 11608-4
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 97 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This part of ISO 11608 specifies reference requirements and test methods for needle-based injection systems (NIS) containing electronics (with or without software) intended to be used with needles and with replaceable or non-replaceable containers. The electronic needle based injection system (ENIS) can be single use, reusable, and/or rechargeable. It is intended to deliver medication to an end-user by self-administration or with assistance. This part of ISO 11608 is not applicable for devices that are capable of delivering drug while connected to an external power supply. This part of ISO 11608 is not applicable for ancillary electrical equipment such as chargers for the device. This part of ISO 11608 is not applicable for needle-free injectors (as covered in ISO 21649).
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