scope:

This Standard specifies sterile, single-use intravascular catheters (hereafter referred to as catheters) which are designed to be inserted or implanted into vessels (including AV shunts and vascular grafts) for diagnostic or therapeutic purposes, or to deliver medical devices to the chosen location. However, this Standard does not apply to catheters with anti-thrombogenic property, coated with biological materials such as heparin and urokinase, catheters with antibacterial effect, coated with antimicrobial agents, and hydratable catheters. 

NOTE 1 JIS T 3268:2012 may be applied until January 31,2021.

NOTE 2 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 and the corrected version: 2014

ISO 10555-3: 2013 Intravascular catheters-Sterile and single-use catheters- Part 3: Central venous catheters

ISO 10555-4: 2013 Intravascular catheters-Sterile and single-use catheters- Part 4: Balloon dilatation catheters

(Overall evaluation: 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.