Jehlové injekční systémy pro zdravotnické použití - Požadavky a metody zkoušení - Část 4: Jehlové injekční systémy obsahující elektroniku (Norma k přímému použití jako ČSN).
NORMA vydaná dňa 1.11.2022
Designation standards: ČSN EN ISO 11608-4
Classification mark: 855930
Catalog number: 515379
Publication date standards: 1.11.2022
The number of pages: 80
Approximate weight : 240 g (0.53 lbs)
Country: Czech technical standard
Kategória: Technické normy ČSN
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