Norm

ISO/DIS 11608-6:2016 en

Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems

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Over deze norm

Status Ontwerp
Aantal pagina's 43
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-04-2016
Taal Engels
This part of ISO 11608 specifies requirements and test methods for on body medication delivery systems (OBDS) for single patient use intended to deliver a discrete volume (bolus) of medicinal product, through needles or catheters incorporating pre-filled or user-filled, replaceable or nonreplaceable reservoirs. This standard is intended to address systems that are primarily intended for self -administration, although some of the steps may be performed by professional and non-professional caregivers. It applies to products intended for subcutaneous, intramuscular or intradermal delivery, where the device, or a part of the device, is to be secured/ adhered/ affixed to the body, e.g. for large volumes or other parameters requiring extended injection time resulting in a user’s inability to hold the device for an extended period of time. Devices intended for different routes of administration (e.g. intravenous, intrathecal, ocular) have unique safety considerations and effectiveness requirements which are not addressed in this standard. These devices may benefit from compliance to applicable elements in this standard, but this compliance may not fulfil the basic safety and effectiveness of those product. This standard is not intended to cover all the requirements for infusion pumps that are addressed in IEC60601-2-24:2012 Ed 2.0 or ISO 28620:2010 Medical devices -- Non-electrically driven portable infusion devices, or medication delivery systems that are not on-body delivery systems. However, this standard contains requirements and tests methods that can be used to help design and evaluate these products.

Details

ICS-code 11.040.25
Nederlandse titel Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems
Engelse titel Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery systems

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