Reference number
ISO 11608-4:2022
© ISO 2025
International Standard
ISO 11608-4:2022
Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
Edition 2
2022-04
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Опубликовано (Версия 2, 2022)

ISO 11608-4:2022

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Тезис

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.

Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2022-04
    Исправленный вариант (английский)
     : 2024-12
    Исправленный вариант (Французский)
     : 2024-12
    Этап
    : Опубликование международного стандарта [60.60]
  • Версия
     : 2
  • Технический комитет :
    ISO/TC 84
    ICS :
    11.040.25 
  • RSS обновления

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