Detaljer på forslag

Transfusions- og infusionssæt og -tilbehør – Kompatibilitet med infusionsvæsker – Krav og vurderingsmetoder
Forslagstitel på sprog (en): Transfusion and infusion sets and accessories – Infusate compatibility – Requirements and assessment methods
Nummer:DSF/ISO/DIS 18972
Type:Forslag
Kilde:ISO
Udvalg:S-093
Udvalgsnavn:Medicinsk udstyr til administration af medicinale produkter
Forslag udgivet:1. jun 2026
Kommentarfrist:1. aug 2026
Antal kommentarer:0
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Beskrivelse af forslaget:This document applies to transfusion and infusion sets and accessories 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  medical devices which are provided integrated with the medicinal product by the manufacturer (e.g. medicinal product mixed with or coated onto the medical device – medicinal product that has ancillary Primary Mode of Action – PMOA) or where the medical device is provided filled with the medicinal product and is part of the medicinal product primary packaging. 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. NOTE      Annex C provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of this document.

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