ISO/NP 18972

Medical devices — Infusate compatibility — Requirements and assessment methods ISO/NP 18972

Scope

This document applies to medical devices that come into contact with drugs/infusates during their preparation or use. This includes sets and components used for the delivery and/or preparation of drugs as infusates. This document is not intended to address combination medical devices for drug storage.-The method(s) provided are to assess the potential impact on medical device safety and not the functionality/efficacy of the drugs with which the medical device is intended to contact.
The impact of the materials of construction, and/or use of the medical device on the quality of the infusate (i.e., its potential alteration, degradation, or retention by the medical device) is not in scope of this document.
Due to the continuous development of new drugs and clinical practices for administration of medicinal product, the scope of this document will be limited to assessing the impact of drug carrier solutions that form the base of the infusates on the medical device rather than testing drugs/medications themselves.
This document is limited to assessing the integrity of the medical devices after exposure to the carrier solutions for a specified period of time. It is not intended to evaluate the biocompatibility of the medical device as that is covered by ISO 10993.
When the exterior of the medical device will come into contact with other chemicals (e.g. disinfectants), substances (e.g. oils) or potentially degrading processes (e.g. UV light), this must be taken into consideration but is out of scope of this document.