JIS T 3218:2018

Introduction1 Scope2 Normative references3 Terms and definitions4 Configuration and name of each part5 Physical requirements6 Resistance to corrosion7 Biological safety8 Assurance of sterility9 Packaging10 LabellingAnnex A (normative) - Determination of flowrate through the catheterAnnex JA (normative) - Test method for airtightnessAnnex JB (normative) - Test method for air interfusion into the hub assembly during aspirationAnnex JC (normative) - Determination of force at break,Annex JD (normative) - Test method for resistance to corrosionAnnex JE (informative) - Comparison table between JIS and corresponding International StandardBibliography

This Standard specifies requirements for sterilized, single-use central venous catheters for the purpose of injecting drug solution, taking blood, measuring venous pressure, etc., and requirements for the guidewire, dilator, introducer needle, introducer catheter and sheath introducer, which are used for insertion and placement of catheters. However, this Standard does not apply to catheters coated with biologically derived materials such as heparin and urokinase in order to maintain antithrombogenicity, catheters coated with antibacterial agent in order to render the catheters antimicrobial, hydratable catheters or catheters with oxygen saturation determination function.

2018 [01/02/2018]2012 [01/07/2012]2005(R2009) [01/10/2009]2005 ERRATA 2006 [01/09/2006]2005 [25/03/2005]