Your cart is currently empty!
“ISO 23217:2024 Injection systems for self-administration by paediatric patients – Requirements and guidelines for design” has been added to your cart. View cart
ISO 11608:2022
ISO 11608:2022 Needle-based injection systems for medical use – Requirements and test methods – Part 4: Needle-based injection systems containing electronics
CDN $351.00
Description
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.
Edition
2
Published Date
2022-04-07
Status
PUBLISHED
Pages
63
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 20487:2019 Traditional Chinese medicine – Test method of single-use acupuncture needles for electrical stimulation
CDN $115.00 Add to cart -
ISO 11040:2024 Prefilled syringes – Part 7: Packaging systems for sterilized subassembled syringes ready for filling
CDN $233.00 Add to cart -
ISO 80369:2021 Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications
CDN $312.00 Add to cart -
ISO 9997:2020 Dentistry – Cartridge syringes
CDN $115.00 Add to cart
