scope:

This Standard specifies requirements for sterilized, single-use central venous catheters for the purpose of injecting drug solution, taking blood, measuring venous pressure, etc. (hereafter referred to as catheters), 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.

NOTE: The International Standards corresponding to this Standard and the symbol of degree of correspondence are as follows.

ISO 10555-1 : 2013 Intravascular catheters - Sterile and single-use catheters - Part 1 : General requirements

ISO 10555-3 : 2013 Intravascular catheters - Sterile and single-use catheters - Part 3 : Central venous catheters (overall degree : MOD)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standards and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/lEC Guide 21-1.