SIST EN ISO 11070:2015/A1:2018

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen Verwendung - Änderung 1 (ISO 11070:2014/Amd 1:2018)

Introducteurs, dilatateurs et guides intravasculaires stériles non réutilisables - Amendement 1 (ISO 11070:2014/Amd 1:2018)

Sterilni žilni instrumenti za enkratno uporabo - Dopolnilo A1 (ISO 11070:2014/Amd 1:2018)

General Information

• Status: Published
• Public Enquiry End Date: 09-Feb-2018
• Publication Date: 23-Aug-2018
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Jul-2018
• Due Date: 20-Sep-2018
• Completion Date: 24-Aug-2018
• Ref Project: EN ISO 11070:2014/A1:2018 - Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)

Relations

• Amends: SIST EN ISO 11070:2015 - Sterile, single-use intravascular catheter introducers (ISO 11070:2014)
• Effective Date: 01-Sep-2018

Overview

EN ISO 11070:2014/A1:2018 (ISO 11070:2014/Amd 1:2018) is a CEN-endorsed amendment to the international standard for sterile single-use intravascular introducers, dilators and guidewires. Approved July 2018, this amendment clarifies test methods, updates terminology and adds specific test guidance for modern guidewire constructions (including polymer-jacketed wires). The amended standard forms part of the regulatory and quality framework for non‑active vascular access devices and was to be adopted as a national standard across CEN members by January 2019.

Key Topics and Requirements

• Scope and status: Amendment A1 modifies EN ISO 11070:2014 without technical changes to the original text but adds procedural and test clarifications.
• Material-specific guidance: A new note explicitly states that certain requirements apply to guidewires with polymer jackets (NOTE 2).
• Tensile testing terminology: Replaces the term “minimum force at break” with “peak tensile force”, aligning wording with contemporary test practice.
• Test method clarifications:
  • Corrects internal references (e.g., changes to "(see 8.4)" and "(see 8.5)").
  • Adds handling instructions during coil testing: push coils toward the distal end and avoid non‑clinically relevant pull forces.
  • Specifies a split tapered clamp for certain clamp tests, with a closed diameter 0.02 mm less than the minimum guidewire diameter, and removes Figure H.1.
  • Permits manufacturers, based on risk assessment, to apply a slower test speed in I.3.2 to reach the target force.
• Practical test cautions: Emphasizes test setup to avoid artifacts (e.g., improper coil direction, unrealistic pull force) that could invalidate results.

Applications

• Ensures safe performance and consistent testing for single‑use intravascular introducers, dilators and guidewires used in vascular access procedures.
• Supports device design verification, manufacturing quality control, and pre-market technical documentation.
• Useful in establishing clinically relevant test conditions and limits for tensile strength, coil integrity and clamp interactions.

Who should use this standard

• Medical device manufacturers (R&D, QA/RA)
• Test laboratories and conformity assessment bodies
• Hospital procurement and clinical engineering teams evaluating device safety
• Regulatory affairs specialists preparing CE marking/technical files for vascular access devices

Related standards

• ISO 11070 main edition (2014) - base standard for intravascular introducers, dilators and guidewires
• EN 1617:1997 - previously superseded by ISO 11070 (refer to the standard foreword for historical context)

Keywords: EN ISO 11070:2014/A1:2018, ISO 11070, sterile single-use intravascular introducers, dilators, guidewires, medical device standard, tensile testing, polymer-jacketed guidewires, CEN amendment.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2018
Sterilni žilni instrumenti za enkratno uporabo - Dopolnilo A1 (ISO 11070:2014/Amd
1:2018)
Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO
11070:2014/Amd 1:2018)
Sterile Einführungsinstrumente, Dilatatoren und Führungsdrähte zur einmaligen
Verwendung - Änderung 1 (ISO 11070:2014/Amd 1:2018)
Introducteurs, dilatateurs et guides intravasculaires stériles non réutilisables -
Amendement 1 (ISO 11070:2014/Amd 1:2018)
Ta slovenski standard je istoveten z: EN ISO 11070:2014/A1:2018
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11070:2014/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2018
EUROPÄISCHE NORM
ICS 11.040.25
English Version
Sterile single-use intravascular introducers, dilators and
guidewires - Amendment 1 (ISO 11070:2014/Amd
1:2018)
Introducteurs, dilatateurs et guides intravasculaires Sterile Einführungsinstrumente, Dilatatoren und
stériles non réutilisables - Amendement 1 (ISO Führungsdrähte zur einmaligen Verwendung -
11070:2014/Amd 1:2018) Änderung 1 (ISO 11070:2014/Amd 1:2018)
This amendment A1 modifies the European Standard EN ISO 11070:2014; it was approved by CEN on 3 July 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11070:2014/A1:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11070:2014/A1:2018) has been prepared by Technical Committee ISO/TC 84 "
Devices for administration of medicinal products and catheters " in collaboration with Technical
Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2019, and conflicting national standards shall
be withdrawn at the latest by January 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1617:1997.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11070:2014/Amd 1:2018 has been approved by CEN as EN ISO 11070:2014/A1:2018
without any modification.
SIST EN ISO 11070:2015/A
...