BS EN ISO 11608-4:2022
Current
The latest, up-to-date edition.
Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems containing electronics
Hardcopy , PDF
English
21-07-2022
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, Clause14 addresses software life cycle processes. This document does not specify requirements for cybersecurity.
Important note : Users cannot be edited or removed once added to your Multi user PDF.Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.