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STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
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Superseded date: 29-08-2022
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Published date: 01-01-2015
Publisher: Ente Nazionale Italiano di Unificazione (UNI)
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General requirements5 Additional requirements for introducer needles6 Additional requirements for introducer catheters7 Additional requirements for sheath introducers8 Additional requirements for guidewires9 Additional requirements for dilators10 Additional requirements for kits containing combinations of devices specified in this International StandardAnnex A (informative) - Guidance on materials and designAnnex B (normative) - Test method for corrosion resistanceAnnex C (normative) - Method for determining peak tensile force of introducer catheters, sheath introducers, and dilatorsAnnex D (normative) - Test method for liquid leakage from sheath introducers under pressureAnnex E (normative) - Test method for liquid leakage through haemostasis valves of sheath introducersAnnex F (normative) - Test method for fracture of guidewiresAnnex G (normative) - Test method for resistance of guidewires to damage by flexingAnnex H (normative) - Method for determining peak tensile force of guidewiresAnnex I (normative) - Determination of strength of union of needle hub and needleBibliography
Defines 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.
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