Back

ISO 11608-5:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions

General information
Valid from 07.04.2022
Directives or regulations
None
Standard history
Status
Date
Type
Name
07.04.2022
Main
20.09.2012
Main
This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO). General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions: a) medicinal product preparation (e.g. reconstitution); b) needle preparation; c) needle hiding; d) priming; e) dose setting; f) needle insertion; g) injection depth control; h) injection of the medicinal product; i) recording of device functions; NOTE  This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto). j) disabling the NIS-AUTO; k) needle retraction; l) needle shielding; m) needle removal. All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.
*
*
*
PDF
136.52 € incl tax
Paper
136.52 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

ISO 11608-3:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
Newest version Valid from 07.04.2022
Main

ISO 11608-2:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles
Newest version Valid from 07.04.2022
Main

ISO 11608-1:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
Newest version Valid from 07.04.2022
Main

ISO 11040-5:2012

Prefilled syringes -- Part 5: Plunger stoppers for injectables
Newest version Valid from 20.01.2012