Cookies
We need your consent to use the individual data so that you can see information about your interests, among other things. Click "OK" to give your consent.
ČSN EN ISO 11608-4 (855930)
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
Translate name
STANDARD published on 1.11.2022
The information about the standard:
Designation standards: ČSN EN ISO 11608-4
Classification mark: 855930
Catalog number: 515379
Publication date standards: 1.11.2022
SKU: NS-1088345
The number of pages: 80
Approximate weight : 240 g (0.53 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 11608-4 (855930):
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
