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.
| File Size : | 1
file
, 3.8 MB |
| ISBN(s) : | 9780539031300 |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 72 |
| Product Code(s) : | 30387731, 30387731 |
| Published : | 07/21/2022 |
| Same As : | BS EN ISO 11608-4:2022 |
