General criteria

Intermittent catheters, infusion sets, and endotracheal tubes are consumables used in large volumes in urology, anaesthesia, and intensive care. These are disposable items used in direct contact with the blood or body tissues, or for infusion of medicines, parenteral nutrition, blood, and blood products. Patients are exposed to the materials that consumables are made from when they are treated for long intervals of time or during daily use, which can be the case with intermittent catheters. This places extra demands on patient safety and that chemical substances in the consumables should not be hazardous to the health, which is particularly important when treating children and in neonatal care. Another important aspect is assessing the risk of adsorption to or interaction with used plastics and constituent substances during intravenous infusion of medicines, blood and blood products during long infusion times, which has been described.

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Agenda 2030
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General criteria
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Procedures for quality management, control, and handling of information on hazardous chemicalsCoreQualification requirement
Metal content in plasticCoreTechnical specification
Limitation of biocides (antimicrobial substances)CoreTechnical specification
Bisphenol A in plastic, coreCoreTechnical specification
Bisphenols in plastic, advancedAdvancedTechnical specification
Latex-free consumablesCoreTechnical specification
Phthalate-free consumablesCoreTechnical specification
Consumables made from chlorine-free plasticCoreTechnical specification
Phthalate-free endotracheal tubesCoreAward criteria
Halogen-free plastic consumablesAdvancedAward criteria
Information about the climate impact of consumablesCoreAward criteria
Content of Substances of Very High Concern (Candidate List)CoreSpecial contract terms
Content of Substances of Very High Concern (Candidate List)AdvancedSpecial contract terms
Requirements under the ILO core conventionsCoreSpecial contract terms
Sustainable supply chainsAdvancedSpecial contract terms