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
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/84
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| DocumentType |
Standard
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| Pages |
72
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
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.
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