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Standard [WITHDRAWN]

DIN EN ISO 11070:2015-03

Sterile single-use intravascular introducers, dilators and guidewires (ISO 11070:2014); German version EN ISO 11070:2014

German title
Sterile intravaskuläre Einführinstrumente, Dilatatoren und Führungsdrähte zur einmaligen Verwendung (ISO 11070:2014); Deutsche Fassung EN ISO 11070:2014
Publication date
2015-03
Original language
German
Pages
36

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Publication date
2015-03
Original language
German
Pages
36

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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).

Content
ICS
11.040.25
Replacement amendments

This document replaces DIN EN ISO 11070:1999-07 .

This document has been replaced by: DIN EN ISO 11070:2018-10 .

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