Tagasi

ISO 11608-4:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics

Üldinfo
Kehtiv alates 07.04.2022
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
07.04.2022
Põhitekst
17.03.2006
Põhitekst
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.
*
*
*
PDF
205,94 € koos KM-ga
Paber
205,94 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst

EVS-EN ISO 9000:2015

Kvaliteedijuhtimissüsteemid. Alused ja sõnavara
Uusim versioon Kehtiv alates 06.10.2015
Põhitekst

EVS-EN 82304-1:2017

Meditsiinitarkvara. Osa 1: Põhinõuded toote ohutusele
Uusim versioon Kehtiv alates 18.09.2017
Põhitekst

CEN ISO/TS 82304-2:2021

Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021)
Uusim versioon Kehtiv alates 01.09.2021
Põhitekst

ISO 11608-1:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
Uusim versioon Kehtiv alates 07.04.2022