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EVS-EN ISO 10555-1:2009

Sterile, single use intravascular catheters - Part 1: General requirements

General information

Withdrawn from 05.08.2013
Base Documents
ISO 10555-1:1995+Amd 1:1999+Amd 2:2004; EN ISO 10555-1:2009
ICS Groups
11.040.25 Syringes, needles and catheters
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
05.08.2013
Main
EVS-EN ISO 10555-1:2013
Main
EVS-EN ISO 10555-1:2009
Main
EVS-EN ISO 10555-1:1999
Amendment
EVS-EN ISO 10555-1:1999/A2:2004
This  part  of  ISO  10555  specifies  general  requirements for  intravascular  catheters,  supplied  in  the  sterile condition  and  intended  for  Single  use,  for  any  appli- cation. lt  does  not  apply  to  intravascular  catheter  accessories, which  will  be  covered  by  a  separate  Standard.

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Standard monitoring
English (PDF 1 MB)

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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