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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
     :  Published
    Дата публикации
     : 2022-04
  • Версия
     : 2
  • Технический комитет
     : ISO/TC 84 Devices for administration of medicinal products and catheters
  • ICS
     :
    11.040.25 Syringes, needles and catheters

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  2. Интернет-магазин
  3. Каталог стандартов
  4. ТК
  5. ISO/TC 84
  6. ISO 11608-4:2022