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 11608-4:2020)
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| Organization: | DS |
| Status: | active |
| Page Count: | 58 |
| ICS Code (Syringes, needles and catheters): | 11.040.25 |
scope:
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software. The needle-based injection system containing electronics can be single use, reusable, and/or rechargeable. It is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider). This document applies to electronic accessories which are intended to be physically connected to a NIS or NIS-E during the NIS/NIS-E intended use. NOTE - This document includes relevant requirements derived from IEC 60601 series.
Document History
May 9, 2022
Needle-based injection systems for medical use – Requirements and test methods – Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). The needle-based injection system containing...
September 11, 2007
Pen-injectors for medical use – Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges. The...
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 11608-4:2020)
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software. The needle-based injection system containing...
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
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...