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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.25 Syringes, needles and catheters>BS EN ISO 11608-4:2022 Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems containing electronics
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immediate downloadReleased: 2022-07-21
BS EN ISO 11608-4:2022 Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems containing electronics

BS EN ISO 11608-4:2022

Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems containing electronics

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Standard number:BS EN ISO 11608-4:2022
Pages:72
Released:2022-07-21
ISBN:978 0 539 03130 0
Status:Standard
DESCRIPTION

BS EN ISO 11608-4:2022


This standard BS EN ISO 11608-4:2022 Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:
  • 11.040.25 Syringes, needles and catheters
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.