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CEN

EN ISO 10555-6:2017

(Main)

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

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 (ISO 10555-6:2015)

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à cathéter implantables (ISO 10555-6:2015)

L'ISO 10555-6:2015 spécifie les exigences, les performances et les questions liées à la sécurité de l'utilisateur des chambres à cathéter implantables et des cathéters, dans le cadre d'une utilisation intravasculaire de longue durée dans des conditions stériles et à usage unique.
L'ISO 10555-6:2015 ne spécifie pas les exigences, les performances et les questions liées à la sécurité de l'utilisateur des aiguilles non carottantes.

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki (ISO 10555-6:2015)

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

Status
Published
Publication Date
22-Aug-2017
Withdrawal Date
27-Feb-2018
ICS
11.040.25 - Syringes, needles an catheters
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205 - Non-active medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
23-Aug-2017
Due Date
14-Aug-2017
Completion Date
23-Aug-2017
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 10555-6:2017 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)

Relations

Amended By
EN ISO 10555-6:2017/A1:2019 - Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
Effective Date
30-Jan-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10555-6:2017
01-oktober-2017
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki
(ISO 10555-6:2015)
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous
implanted ports (ISO 10555-6:2015)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 6: Subkutan
implantierte Ports (ISO 10555-6:2015)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à
cathéter implantables (ISO 10555-6:2015)
Ta slovenski standard je istoveten z: EN ISO 10555-6:2017
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-6:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 10555-6:2017

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SIST EN ISO 10555-6:2017


EN ISO 10555-6
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2017
EUROPÄISCHE NORM
ICS 11.040.25
English Version

Intravascular catheters - Sterile and single-use catheters -
Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur
réutilisables - Partie 6: Chambres à cathéter einmaligen Verwendung - Teil 6: Subkutan
implantables (ISO 10555-6:2015) implantierte Ports (ISO 10555-6:2015)
This European Standard was approved by CEN on 30 July 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-6:2017 E
worldwide for CEN national Members.

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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

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SIST EN ISO 10555-6:2017
EN ISO 10555-6:2017 (E)
European foreword
The text of ISO 10555-6:2015 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 10555-6:2017 by 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 February 2018, and conflicting national standards
shall be withdrawn at the latest by February 2018.
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 has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use o
...

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