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)

1.1 This part of ISO 10524 applies to pressure regulators integrated with cylinder valves (as defined in 3.16) intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases:
- oxygen;
- nitrous oxide;
- air for breathing;
- helium;
- carbon dioxide;
- xenon;
- specified mixtures of the gases listed above;
- air for driving surgical tools;
- nitrogen for driving surgical tools.
1.2 These pressure regulators integrated with cylinder valves are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices that control and measure the flow of the medical gas delivered.

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• Status: Withdrawn
• Public Enquiry End Date: 14-Dec-2010
• Publication Date: 21-May-2013
• Withdrawal Date: 14-Mar-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 23.060.40 - Pressure regulators
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 14-Mar-2019
• Due Date: 06-Apr-2019
• Completion Date: 15-Mar-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: 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

• Amends: SIST 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: 01-Jun-2013
• Replaced By: SIST 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-Apr-2019
• Replaced By: SIST 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: 08-Jun-2022
• Amends: SIST 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
SIST EN ISO 10524-3:2006/A1:2013
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
SIST EN ISO 10524-3:2006/A1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 10524-3:2006/A1:2013

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SIST EN ISO 10524-3:2006/A1:2013


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.

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SIST EN ISO 10524-3:2006/A1:2013
EN ISO 10524-3:2006/A1:2013 (E)
Contents Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 10524-3:2006/A1:2013
EN ISO 10524-3:2006/A1:2013 (E)
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
...

SLOVENSKI STANDARD
SIST EN ISO 10524-3:2006/oprA1:2010
01-november-2010
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYVNORSXYHQWLORY
MHNOHQN,62'$0
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (ISO 10524-3:2005/DAM 1:2010)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO 10524-3:2005/DAM 1:2010)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles de gaz (ISO 10524-3:2005/DAM 1:2010)
Ta slovenski standard je istoveten z: EN ISO 10524-3:2006/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
SIST EN ISO 10524-3:2006/oprA1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 10524-3:2006/oprA1:2010

---------------------- Page: 2 ----------------------
SIST EN ISO 10524-3:2006/oprA1:2010


EUROPEAN STANDARD
DRAFT
EN ISO 10524-3:2006
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
September 2010
ICS 11.040.10
English Version
Pressure regulators for use with medical gases - Part 3:
Pressure regulators integrated with cylinder valves (ISO 10524-
3:2005/DAM 1:2010)
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 (ISO 10524-3:2005/DAM 1:2010) 3:2005/DAM 1:2010)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 215.

This draft amendment A1, if approved, will modify the European Standard EN ISO 10524-3:2006. If this draft becomes an amendment,
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.

This draft amendment was established by CEN 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 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-3:2006/prA1:2010: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 10524-3:2006/oprA1:2010
EN ISO 10524-3:2006/prA1:2010 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 10524-3:2006/oprA1:2010
EN ISO 10524-3:2006/prA1:2010 (E)
Foreword
This document (EN ISO 10524-3:2006/prA1:2010) 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 document is currently submitted to the parallel Enquiry.
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).
Endorsement notice
The text of ISO 10524-3:2005/DAM 1:2010 has been approved by CEN as a EN ISO 10524-3:2006/prA1:2010
without any modification.

3

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SIST EN ISO 10524-3:2006/oprA1:2010

---------------------- Page: 6 ----------------------
SIST EN ISO 10524-3:2006/oprA1:2010
DRAFT AMENDMENT ISO 10524-3:2005/DAmd 1
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2010-09-16 2011-02-16
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Pressure regulators for use with medical gases —
Part 3:
Pressure regulators integrated with cylinder valves
AMENDMENT 1
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles de gaz
AMENDEMENT 1
ICS 11.040.10

ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
RE
...