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Norm
ÖNORM EN ISO 11608-4
Issue date: 2022 10 15
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-base...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 78 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
This document does not specify requirements for cybersecurity
ÖNORM EN ISO 11608-4
2022 10 15
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-base...
Norm
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ÖNORM EN ISO 11608-4
2007 11 01
Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromech...
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