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  • BSI
    BS EN ISO 11608-4:2022 - TC Tracked Changes. Needle-based injection systems for medical use. Requirements and test methods - Needle-based injection systems containing electronics
    Edition: 2022
    $798.15
    / user per year

Description of BS EN ISO 11608-4:2022 - TC 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 electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system 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 that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use. This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use. This document does not specify requirements for software in programmable NIS-E. NOTE       IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes. This document does not specify requirements for cybersecurity.

Standard NumberBS EN ISO 11608-4:2022 - TC
TitleTracked Changes. Needle-based injection systems for medical use. Requirements and test methods - Needle-based injection systems containing electronics
StatusDefinitive
Publication Date2022-07-27
DescriptorsElectromechanical devices, Performance testing, Injection guns, Parenteral infusion equipment, Injection instruments, Medical instruments, Electrical medical equipment, Performance, Medical equipment, Drug administration, Syringes
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/84
ISBN978 0 539 23201 1
PublisherBSI
Pages160

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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