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

Status
Published
Public Enquiry End Date
19-Jul-2019
Publication Date
17-Nov-2019
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
04-Nov-2019
Due Date
09-Jan-2020
Completion Date
18-Nov-2019

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Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 10555-6:2017/A1:2019
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
SIST EN ISO 10555-6:2017/A1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10555-6:2017/A1:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 10555-6:2017/A1:2019
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.
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SIST EN ISO 10555-6:2017/A1:2019
EN ISO 10555-6:2017/A1:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 10555-6:2017/A1:2019
EN ISO 10555-6:2017/A1:2019 (E)
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
...

SLOVENSKI STANDARD
SIST EN ISO 10555-6:2017/oprA1:2019
01-julij-2019

Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 6. del: Podkožni vsadki -

Dopolnilo A1 (ISO 10555-6:2015/DAM 1:2019)

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous

implanted ports - Amendment 1 (ISO 10555-6:2015/DAM 1:2019)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung — Teil 6:
Subkutan implantierte Ports - ÄNDERUNG 1 (ISO 10555-6:2015/DAM 1:2019)

Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 6: Chambres à

cathéter implantables - Amendement 1 (ISO 10555-6:2015/DAM 1:2019)
Ta slovenski standard je istoveten z: EN ISO 10555-6:2017/prA1
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 10555-6:2017/oprA1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10555-6:2017/oprA1:2019
---------------------- Page: 2 ----------------------
SIST EN ISO 10555-6:2017/oprA1:2019
DRAFT AMENDMENT
ISO 10555-6:2015/DAM 1
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2019-05-13 2019-08-05
Intravascular catheters — Sterile and single-use
catheters —
Part 6:
Subcutaneous implanted ports
AMENDMENT 1
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 6: Chambres à cathéter implantables
AMENDEMENT 1
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 10555-6:2015/DAM 1:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
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SIST EN ISO 10555-6:2017/oprA1:2019
ISO 10555-6:2015/DAM 1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 10555-6:2017/oprA1:2019
ISO 10555-6:2015/DAM 1:2019(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of na

...

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