scope:

This Standard specifies requirements for drainage catheters and their accessory devices, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of accumulated fluid or air to the exterior. This Standard is not applicable to those with a special shape at the tip (pigtail, balloon, etc.) to maintain placement in the body, or to the following :

- suction catheters used by airway;

- tracheal catheters (tracheal tube);

- urethral catheter;

- ureteral stents, biliary stents, and other stents;

- drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;

- neuraxial catheters used for removal of cerebrospinal fluid;

- enteral catheters used for removal of solutions or substances from the gastrointestinal tract;

- catheters for nephrostomy or cystostomy;

- catheters and tubes designed for the biliary tract.

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

ISO 20697 : 2018 Sterile drainage catheters and accessory devices for single use (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/IEC Guide 21-1.