Overview

This standard specifies requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in ISO 10555-1. In addition to the requirements for sterilization, biocompatibility, corrosion resistance or radio-detectability, additional requirements for the dimensions, hubs, tips and peak tensile force are specified. Furthermore, the annexes contain descriptions of test methods, for example for determination of the corrosion resistance, freedom from leakage, tensile strength, breaking and bending strength. This International Standard has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany). The responsible German committee is Working Committee NA 063-01-02 AA "Katheter, Drainagen" ("Catheters, drainages") at the DIN Standards Committee Medicine (NAMed).

Document: references other documents

Responsible national committee

NA 176-04-01 AA - Catheters, drainages  

Responsible european committee

CEN/TC 205 - Non-active medical devices