Standard Number: YY/T 0817-2010(YY/T0817-2010)
Chinese:带定位球囊的肠营养导管物理性能要求及试验方法
English:Physical Performance requirements and test methods for enteral feeding catheters with a retention balloon
Effective Date:2012-06-01
ICS:11.100
Standard Applicability:This standard covers the physical property requirements for single-use enteral nutrition catheters with positioning balloons. Enteral nutrition catheters with localized balloons are used to provide nutrition and/or medication to patients through the patient’s natural lumen (transnasal, transoral) or through a surgical fistula. The product can be manufactured in various sizes from different materials (e.g. silicone rubber, polymers such as polyurethane, and combinations of these materials) and can be supplied in a non-sterile form, sterilized prior to use, or in a sterile form for single use only. This standard does not address the biological requirements, chemical requirements, packaging and labeling requirements for enteral nutrition catheters with localized balloons.
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