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
SIST EN ISO 10555-1:2013
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
EN ISO 10555-1:2013 (E) 2 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
SIST EN ISO 10555-1:2013
EN ISO 10555-1:2013 (E) 3 Foreword This document (EN ISO 10555-1:2013, Corrected version 2013-07-01) 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. 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, Portu
...
SLOVENSKI STANDARD
SIST EN ISO 10555-1:2013
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
SIST EN ISO 10555-1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10555-1:2013
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SIST EN ISO 10555-1:2013
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.
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SIST EN ISO 10555-1:2013
EN ISO 10555-1:2013 (E)
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
2
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SIST EN ISO 10555-1:2013
EN ISO 10555-1:2013 (E)
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
...
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