Standard Swedish standard · SS-EN ISO 11608-4:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)

Status: Valid

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Standard Swedish standard · SS-EN ISO 11608-4:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
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Scope
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.

Subjects

Syringes, needles and catheters (11.040.25)


Buy this standard

Standard Swedish standard · SS-EN ISO 11608-4:2022

Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
Subscribe on standards - Read more Dölj
Price: 1 615 SEK
standard ikon pdf

PDF

Price: 1 615 SEK
standard ikon

Paper

Price: 2 584 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80035114

Edition: 2

Approved: 5/9/2022

No of pages: 76

Replaces: SS-EN ISO 11608-4:2007