BS EN ISO 11070:2014+A1:2018 Sterile single-use intravascular introducers, dilators and guidewires

BS EN ISO 11070:2014+A1:2018

Sterile single-use intravascular introducers, dilators and guidewires

Status : Current   Published : November 2014



What is this standard about?

This International 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.

Standard NumberBS EN ISO 11070:2014+A1:2018
TitleSterile single-use intravascular introducers, dilators and guidewires
Publication Date30 November 2014
Normative References(Required to achieve compliance to this standard)ISO 594-1, ISO 594-2, ISO 8601, ISO 10993-1, ISO 7886-1:2017
Informative References(Provided for Information)ISO 10555-4, ISO 17665, ISO 9626, ISO 15223-1:2012, ASTM F640-12, ISO 11135, ISO 11137, DIN 13273-7, ISO 10555-5, ISO 10555-3, ISO 10555-1, ISO 7864
ReplacesBS EN ISO 11070:1999
International RelationshipsEN ISO 11070:2014/A1:2018,ISO 11070:2014/Amd 1:2018
Amended ByCorrigendum, November 2018; Corrigendum, September 2018
DescriptorsDilators (surgical instruments), Testing conditions, Designations, Instructions for use, Wires, Surgical equipment, Catheters, Mechanical testing, Physical testing, Strength of materials, Syringes, Valves, Design, Disposable, Tensile testing, Performance testing, Breaking load, Parenteral infusion equipment, Medical instruments, Dimensions, Leak tests, Size coding, Test equipment, Sterile equipment, Injection instruments
Title in FrenchIntroducteurs, dilatateurs et guides intravasculaires stériles non réutilisables
Title in GermanSterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen Verwendung
ISBN978 0 539 02914 7
File Size1.066 MB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Access, view and download standards with multiple user access, across multiple sites with BSOL

Develop a PAS

Develop a fast-track standardization document in 9-12 months

Worldwide Standards
We can source any standard from anywhere in the world