EN ISO 10524-3:2006/A1:2013

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtration and information to be supplied by the manufacturer (ISO 10524-3:2005/Amd 1:2013)

2012-08-06 EMA: Draft for // vote received in ISO/CS (see notification of 2012-08-06 in dataservice).
2012-01-04 EMA: Consultant Virefleau replaced by T. Wilkes according to e-mail sent to dataservice on 2011-12-01.
DOW=DAV+36
2011-07-12 EMA: Draft for 2nd // ENQ received in ISO/CS (see notification of 2011-07-06 in dataservice).

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in Flaschenventilen (ISO 10524-3:2005/Amd 1:2013)

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans les robinets des bouteilles de gaz - Amendement 1: Filtrage et informations à fournir par le fabricant (ISO 10524-3:2005/Amd 1:2013)

Tlačni regulatorji za medicinske pline - 3. del: Tlačni regulatorji v sklopu ventilov jeklenk - Dopolnilo 1: Filtracija in informacije, ki jih priskrbi proizvajalec (ISO 10524-3:2005/Amd 1:2013)

1.1 Ta del standarda ISO 10524 velja za tlačne regulatorje v sklopu ventilov jeklenk (kot je opredeljeno v točki 3.16), namenjene doziranju medicinskih plinov pri zdravljenju, diagnostičnem ocenjevanju, oskrbi bolnikov in ravnanju z njimi, za naslednje medicinske pline:
– kisik,
– dušikov oksid,
– zrak za dihanje,
– helij,
– ogljikov dioksid,
– ksenon,
– določene zmesi zgoraj navedenih plinov,
– zrak za delovanje kirurških instrumentov,
– dušik za delovanje kirurških instrumentov.
1.2 Ti tlačni regulatorji v sklopu ventilov jeklenk so namenjeni namestitvi v jeklenke z nazivnim polnilnim tlakom do 25000 kPa pri 15 °C in jih je mogoče uporabljati skupaj z napravami, ki nadzorujejo in merijo tok dovajanega medicinskega plina.

General Information

• Status: Withdrawn
• Publication Date: 05-Mar-2013
• Withdrawal Date: 29-Jan-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 23.060.40 - Pressure regulators
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Jan-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10524-3:2006/A1:2013 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtration and information to be supplied by the manufacturer (ISO 10524-3:2005/Amd 1:2013)

Relations

• Replaced By: EN ISO 10524-3:2019 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO 10524-3:2019)
• Effective Date: 01-Mar-2017
• Amends: EN ISO 10524-3:2006 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2013
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYVNORSXYHQWLORY
MHNOHQN'RSROQLOR)LOWUDFLMDLQLQIRUPDFLMHNLMLKSULVNUELSURL]YDMDOHF,62
$PG
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves - Amendment 1: Filtration and information to be supplied by the
manufacturer (ISO 10524-3:2005/Amd 1:2013)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO 10524-3:2005/Amd 1:2013)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles de gaz - Amendement 1: Filtrage et informations à fournir par
le fabricant (ISO 10524-3:2005/Amd 1:2013)
Ta slovenski standard je istoveten z: EN ISO 10524-3:2006/A1:2013
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10524-3:2006/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2013
ICS 11.040.10
English Version
Pressure regulators for use with medical gases - Part 3:
Pressure regulators integrated with cylinder valves - Amendment
1: Filtration and information to be supplied by the manufacturer
(ISO 10524-3:2005/Amd 1:2013)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
3: Détendeurs intégrés dans les robinets des bouteilles de Teil 3: Druckminderer in Flaschenventilen (ISO 10524-
gaz - Amendement 1: Filtrage et informations à fournir par 3:2005/Amd 1:2013)
le fabricant (ISO 10524-3:2005/Amd 1:2013)
This amendment A1 modifies the European Standard EN ISO 10524-3:2006; it was approved by CEN on 1 March 2013.

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, 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 Ref. No. EN ISO 10524-3:2006/A1:2013: 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 . 4

Foreword
This document (EN ISO 10524-3:2006/A1:2013) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory
and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 10524:2006 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by September 2013, and
conflicting national standards shall be withdrawn at the latest by March 2016.
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 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.
For relationship with EU Directive, 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
...