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EVS-EN ISO 11070:2014

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

General information

Valid from 09.12.2014
Base Documents
ISO 11070:2014; EN ISO 11070:2014
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.07.2018
Amendment
EVS-EN ISO 11070:2014/A1:2018
09.12.2014
Main
EVS-EN ISO 11070:2014
01.07.2001
Main
EVS-EN ISO 11070:2001
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.

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Standard monitoring
English (PDF 418 KB)

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Amendment

EVS-EN ISO 11070:2014/A1:2018

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)
Newest version Valid from 16.07.2018
Main

EVS-EN ISO 80369-7:2021

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2021)
Newest version Valid from 01.06.2021
Main

EVS-EN ISO 10555-1:2013

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013)
Withdrawn from 15.12.2023
Main

EVS-EN ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015)
Newest version Valid from 08.06.2015

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Amendment

EVS-EN ISO 11070:2014/A1:2018

Sterile single-use intravascular introducers, dilators and guidewires - Amendment 1 (ISO 11070:2014/Amd 1:2018)
Newest version Valid from 16.07.2018
Main

EVS-EN ISO 10555-1:2013

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013)
Withdrawn from 15.12.2023
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EVS-EN ISO 10993-3:2014

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Newest version Valid from 07.11.2014
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EVS-EN ISO 25539-1:2017

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English