ISO/TC 84/WG 14 - Needle-based injection system (NIS) - Electrotechnical requirements and test methods
Systèmes d’injection à aiguille – Exigences et méthodes d’essai électrotechniques
General Information
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.
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Frequently Asked Questions
ISO/TC 84/WG 14 is a Working Group within the International Organization for Standardization (ISO). It is named "Needle-based injection system (NIS) - Electrotechnical requirements and test methods". This committee has published 1 standards.
ISO/TC 84/WG 14 develops ISO standards in the area of Information technology. Currently, there are 1 published standards from this working group.
The International Organization for Standardization (ISO) is an independent, non-governmental international organization that develops and publishes international standards. Founded in 1947 and headquartered in Geneva, Switzerland, ISO brings together experts from 170+ member countries to share knowledge and develop voluntary, consensus-based standards that support innovation and provide solutions to global challenges.
A Working Group in ISO is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.