SIST EN ISO 10555-6:2017/A1:2019
(Amendment)Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung — Teil 6: Subkutan implantierte Ports - Änderung 1 (ISO 10555-6:2015/Amd 1:2019)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à cathéter implantables - Amendement 1 (ISO 10555-6:2015/Amd 1:2019)
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki - Dopolnilo A1 (ISO 10555-6:2015/Amd 1:2019)
Standard ISO 10555-6:2015 opredeljuje zahteve, učinkovitost in varnostna vprašanja, povezana s podkožnimi vsadki in katetri za intravaskularno dolgoročno uporabo, ki so dobavljeni sterilni in so namenjeni za enkratno uporabo.
Standard 10555-6:2015 ne določa zahtev, zmogljivosti in varnostnih vprašanj, povezanih z iglami, ki preprečujejo puščanje.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2019
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki -
Dopolnilo A1 (ISO 10555-6:2015/Amd 1:2019)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous
implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung — Teil 6:
Subkutan implantierte Ports - Änderung 1 (ISO 10555-6:2015/Amd 1:2019)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à
cathéter implantables - Amendement 1 (ISO 10555-6:2015/Amd 1:2019)
Ta slovenski standard je istoveten z: EN ISO 10555-6:2017/A1:2019
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 10555-6:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.040.25
English Version
Intravascular catheters - Sterile and single-use catheters -
Part 6: Subcutaneous implanted ports - Amendment 1 (ISO
10555-6:2015/Amd 1:2019)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur
réutilisables - Partie 6: Chambres à cathéter einmaligen Verwendung - Teil 6: Subkutan
implantables - Amendement 1 (ISO 10555- implantierte Ports - Änderung 1 (ISO 10555-
6:2015/Amd 1:2019) 6:2015/Amd 1:2019)
This amendment A1 modifies the European Standard EN ISO 10555-6:2017; it was approved by CEN on 6 September 2019.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-6:2017/A1:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10555-6:2017/A1:2019) 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 Amendment to the European Standard EN ISO 10555-6:2017 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2020, and
conflicting national standards shall be withdrawn at the latest by April 2020.
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.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorseme
...
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