EN ISO 10555-1:2013
(Main)Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2014-01-15)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2014-01-15)
ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2014-01-15)
Die vorliegende Internationale Norm behandelt die Messung des Wärmewerts von Erdgas und Syntheseerd-gasen mit nicht-trennenden Verfahren, d. h. Verfahren, die weder eine Bestimmung der Gaszusammen-setzung noch eine Berechnung aus dieser erfordern. Die Norm beschreibt die Prinzipien des Betriebs einer Auswahl von für diesen Zweck gebräuchlichen Messgeräten und enthält Anleitungen für die Auswahl, Bewertung, Leistungsbeurteilung, Installation und den Betrieb dieser.
Wärmewerte können auf Grundlage der Masse, Stoffmenge oder Volumen angegeben werden, wobei Letztgenanntes die gebräuchlichste Form ist. Der Arbeitsbereich für den volumenbezogenen Brennwert von Erdgas liegt üblicherweise zwischen 30 MJ/m3 und 45 MJ/m3 bei Standardbezugsbedingungen (siehe ISO 13443). Der zugehörige Bereich für den Wobbeindex liegt gewöhnlich zwischen 40 MJ/m3 und 60 MJ/m3.
Durch diese Internationale Norm werden die Behauptungen eines gewerblichen Herstellers bezüglich der Leistung eines Messgeräts weder bestätigt noch angefochten. Die zentrale Behauptung ist, dass die Zweckmäßigkeit für eine bestimmte Anwendung (definiert in Form einer Reihe von spezifischen Betriebs-anforderungen) nur mit Hilfe eines sorgfältig gestalteten Programms von experimentellen Untersuchungen beurteilt werden kann. Für diese Prüfungen werden Anleitungen bezüglich des sachgerechten Inhalts bereit-gestellt.
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO 10555-1:2013, Version corrigé 2014-01-15)
L'ISO 10555-1:2013 spécifie les exigences générales relatives aux cathéters intravasculaires fournis en condition stérile, non réutilisables, pour toute application.
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:2013, popravljena verzija 2014-01-15)
Ta del standarda ISO 10555 določa splošne zahteve za žilne katetre, dobavljene v sterilnem stanju in namenjene za enkratno uporabo, za katero koli vrsto uporabe. Ne uporablja se za dodatke žilnih katetrov, na primer tiste, ki jih zajema ISO 11070.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve (ISO 10555-1:2013, popravljena verzija 2013-07-01)Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2013-07-01)Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO 10555-1:2013, Version corrigé 2013-07-01)Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2013-07-01)11.040.25Injekcijske brizge, igle in katetriSyringes, needles an cathetersICS:Ta slovenski standard je istoveten z:EN ISO 10555-1:2013SIST EN ISO 10555-1:2013en01-november-2013SIST EN ISO 10555-1:2013SLOVENSKI
STANDARDSIST EN ISO 10555-1:20091DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 10555-1
July 2013 ICS 11.040.25 Supersedes EN ISO 10555-1:2009English Version
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2013, Corrected version 2013-07-01)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences générales (ISO 10555-1:2013, Version corrigé 2013-07-01)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1: Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2013-07-01) This European Standard was approved by CEN on 29 May 2013.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10555-1:2013: ESIST EN ISO 10555-1:2013
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC .4
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of Directive 93/42/EEC amended by Directive 2007/47/EEC. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive. NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1— Correspondence between this European Standard and Directive 93/42/EEC amended by Directive 2007/47/EEC Essential Requirements (ERs) of Directive 93/42/EEC
Clause(s)/sub-clause(s) of this EN ISO 10555-1 7.3 4.5* 4.9 4.10* 7.5 4.4* 8.1 4.1* 6.2 c) and d)* 8.3 4.1* 6.2 c) and d)* 8.4 4.1**** 6.2 d)* 9.1 4.8 4.9 4.10 6.3 b), c) and i) 9.2 4.2 4.4 4.6 4.7 4.8 4.9 4.10 4.11 4.12 5 12.7.1** 4.4 4.6 4.7 4.9 4.10 SIST EN ISO 10555-1:2013
13.3 k) 6.3 b) and f) 13.3 m) 6.2 d) 13.4 6.2 i) 6.3 a) 13.6 a) 6.3 a) *** 13.6 b) 6.3 b) 13.6 c) 6.3 c) and f) 13.6 e) 6.3 f) 13.6 f) 6.3 g) 13.6 g) 6.3 d) 13.6 k) 6.3 b) and f) 13.6 l) 6.3 b) and g) 13.6 n) 6.3 e) 13.6 q) 6.3 h) (*) Not fully covered as the requirements are depended on the specific product. (**) For the user, only 4.7 is applicable. (***) Method of sterilisation not required in the instruction for use as it is required on the device or primary packing. (****) Only concerning sterilisation aspects.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. SIST EN ISO 10555-1:2013
ISO 10555-1:2013(E) ii © ISO 2013 – All rights reservedCOPYRIGHT PROTECTED DOCUMENT©
ISO 2013All rights reservedä Unless otherwise speci Ðiedá no part of this publication may be reproduced or utilized otherwise in any form or by any meansá electronic or mechanicalá including photocopyingá or posting on the internet or an intranetá without prior written permissionä Permission can be requested from either ISO at the address below or ISOïs member body in the country of the requester.ISO copyright of ÐiceTel. + 41 22 749 01 11Fax + 41 22 749 09 47Eæmail copyright 7isoäorgWeb www.iso.orgPublished in SwitzerlandSIST EN ISO 10555-1:2013
ISO 10555-1:2013(E) © ISO 2013 – All rights reserved iiiContents PageForeword .iv1 Scope .12 Normative references .1FuFTermsFandFdeFÐinitions .14 Requirements .4 vä s General .4 vä t Radioædetectability .4 vä u Biocompatibility .44.4 Surface .44.5 Corrosion resistance .44.6 Peak tensile force .44.7 Freedom from leakage .5 vä z Hubs .54.9 Flowrate .54.10 Power injection .54.11 Side holes .54.12 Distal tip .55 Designation of nominal size.55.1 Outside diameter .55.2 Nominal effective length .66 Information to be supplied by the manufacturer .6 xä s General .6 xä t Mar .66.3 Instructions for use .7 xä v Marking on the secondary packaging.7Annex A (normative) Test method for corrosion resistance .8Annex B (normative) Method for determining peak tensile force .9Annex C (normative) Test method for liquid leakage under pressure .11Annex D (normative) Test method for air leakage into hub assembly during aspiration .13Annex E (normative)FDeterminationFofFFÐlowrateFthroughFcatheter .15Annex F (normative) Test for burst pressure under static conditions.17Annex G (normative)FPowerFinjectionFtestFforFFÐlowrateFandFdeviceFFforFproductsFindicated for power injection) .19Annex H (informative)FUnitsFofFmeasurementFsystemsFotherFthanFthoseFspeciFÐiedFinFthisFpartFofFISO 10555, which
...
SLOVENSKI STANDARD
01-november-2013
Nadomešča:
SIST EN ISO 10555-1:2009
SIST EN ISO 10555-2:2000
SIST EN ISO 10555-2:2000/AC:2002
Žilni katetri - Sterilni žilni katetri za enkratno uporabo - 1. del: Splošne zahteve
(ISO 10555-1:2013, popravljena verzija 2014-01-15)
Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
(ISO 10555-1:2013, Corrected version 2014-01-15)
Intravaskuläre Katheter - Sterile Katheter zur einmaligen Verwendung - Teil 1:
Allgemeine Anforderungen (ISO 10555-1:2013, korrigierte Fassung 2014-01-15)
Cathéters intravasculaires - Cathéters stériles et non réutilisables - Partie 1: Exigences
générales (ISO 10555-1:2013, Version corrigé 2014-01-15)
Ta slovenski standard je istoveten z: EN ISO 10555-1:2013
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.
EUROPEAN STANDARD
EN ISO 10555-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2013
ICS 11.040.25 Supersedes EN ISO 10555-1:2009, EN ISO 10555-2:1997
English Version
Intravascular catheters - Sterile and single-use catheters - Part
1: General requirements (ISO 10555-1:2013, Corrected version
2014-01-15)
Cathéters intravasculaires - Cathéters stériles et non Intravaskuläre Katheter - Sterile Katheter zur einmaligen
réutilisables - Partie 1: Exigences générales (ISO 10555- Verwendung - Teil 1: Allgemeine Anforderungen (ISO
1:2013, Version corrigé 2014-01-15) 10555-1:2013, korrigierte Fassung 2014-01-15)
This European Standard was approved by CEN on 29 May 2013.
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, 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
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10555-1:2013 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC .4
Foreword
This document (EN ISO 10555-1:2013, Corrected version 2014-01-15) has been prepared by Technical
Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” in
collaboration with 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 January 2014, and conflicting national standards shall be withdrawn at
the latest by January 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10555-1:2009, EN ISO 10555-2:1997.
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.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10555-1:2013, Corrected version 2014-01-15 has been approved by CEN as EN ISO 10555-
1:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive
2007/47/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of
Directive 93/42/EEC amended by Directive 2007/47/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1— Correspondence between this European Standard and Directive 93/42/EEC amended by
Directive 2007/47/EEC
Essential Requirements (ERs) of Directive Clause(s)/sub-clause(s) of this
93/42/EEC EN ISO 10555-1
7.3 4.5*
4.9
4.10*
7.5 4.4*
8.1 4.1*
6.2 c) and d)*
8.3 4.1*
6.2 c) and d)*
8.4 4.1****
6.2 d)*
9.1 4.8
4.9
4.10
6.3 b), c) and i)
9.2 4.2
4.4
4.6
4.7
4.8
4.9
4.10
4.11
4.12
12.7.1** 4.4
4.6
4.7
4.9
4.10
4.11
4.12
12.7.4 4.9
4.10
12.8.1 4.9
4.10
13.1 6.1
6.2 a), b), f), g), h), i), j), k)
6.4
13.2 6.1
13.3 a) 6.2 a)
13.3 b) 6.2 b)
13.3 c) 6.2 c)
13.3 d) 6.2 e)
13.3 e) 6.2 f)
13.3 f) 6.2 g)
13.3 i) 6.2 h)
13.3 j) 6.2 i) and j)
6.3 c) and i)
13.3 k) 6.3 b) and f)
13.3 m) 6.2 d)
13.4 6.2 i)
6.3 a)
13.6 a) 6.3 a) ***
13.6 b) 6.3 b)
13.6 c) 6.3 c) and f)
13.6 e) 6.3 f)
13.6 f) 6.3 g)
13.6 g) 6.3 d)
13.6 k) 6.3 b) and f)
13.6 l) 6.3 b) and g)
13.6 n) 6.3 e)
13.6 q) 6.3 h)
(*) Not fully covered as the requirements are depended on the specific product.
(**) For the user, only 4.7 is applicable.
(***) Method of sterilisation not required in the instruction for use as it is required on the device
or primary packing.
(****) Only concerning sterilisation aspects.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 10555-1
Second edition
2013-06-15
Corrected version
2014-01-15
Intravascular catheters — Sterile and
single-use catheters —
Part 1:
General requirements
Cathéters intravasculaires — Cathéters stériles et non réutilisables —
Partie 1: Exigences générales
Reference number
ISO 10555-1:2013(E)
©
ISO 2013
ISO 10555-1:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
ISO 10555-1:2013(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 4
4.1 General . 4
4.2 Radio-detectability . 4
4.3 Biocompatibility . 4
4.4 Surface . 4
4.5 Corrosion resistance . 4
4.6 Peak tensile force . 4
4.7 Freedom from leakage . 5
4.8 Hubs . 5
4.9 Flowrate . 5
4.10 Power injection . 5
4.11 Side holes . 5
4.12 Distal tip . 5
5 Designation of nominal size. 5
5.1 Outside diameter . 5
5.2 Nominal effective length . 6
6 Information to be supplied by the manufacturer . 6
6.1 General . 6
6.2 Marking on the device and/or primary packaging . 6
6.3 Instructions for use . 7
6.4 Marking on the secondary packaging. 7
Annex A (normative) Test method for corrosion resistance . 8
Annex B (normative) Method for determining peak tensile f
...
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