EN 738-1:1997/A1:2002

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices

To amend 738-1 so as to include requirements for use with nitric oxide/nitrogen mixtures

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und Druckminderer mit Durchflussmessgeräten

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1: Détendeurs et détendeurs-débitmètres

Ajouter à la liste des gaz médicaux :
« mélanges NO/N2 (NO £ 1 000 µl/l) »

Tlačni regulatorji za medicinske pline - 1. del: Tlačni regulatorji in tlačni regulatorji s pretočnimi merilniki

General Information

• Status: Withdrawn
• Publication Date: 16-Apr-2002
• Withdrawal Date: 31-Jan-2006
• 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/WG 3 - Medical gas supply systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Feb-2006
• Completion Date: 01-Feb-2006
• 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 738-1:2000/A1:2002 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices

Relations

• Amends: EN 738-1:1997 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10524-1:2006 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 738-1:2000/A1:2002
01-november-2002
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLLQWODþQLUHJXODWRUML
VSUHWRþQLPLPHULOQLNL
Pressure regulators for use with medical gases - Part 1: Pressure regulators and
pressure regulators with flow metering devices
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1: Détendeurs et détendeurs
-débitmetres
Ta slovenski standard je istoveten z: EN 738-1:1997/A1:2002
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
SIST EN 738-1:2000/A1:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 738-1:2000/A1:2002

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SIST EN 738-1:2000/A1:2002
EUROPEAN STANDARD
EN 738-1:1997/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2002
ICS 11.040.10; 23.060.40
English version
Pressure regulators for use with medical gases - Part 1:
Pressure regulators and pressure regulators with flow metering
devices
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
1: Détendeurs et détendeurs-débitmètres Teil 1: Druckminderer und Druckminderer mit
Durchflussmessgeräten
This amendment A1 modifies the European Standard EN 738-1:1997; it was approved by CEN on 4 March 2002.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 738-1:1997/A1:2002 E
worldwide for CEN national Members.

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SIST EN 738-1:2000/A1:2002
EN 738-1:1997/A1:2002 (E)
Foreword
This document (EN 738-1:1997/A1:2002) has been prepared by Technical Committee CEN/TC 215 "Respiratory
and anaesthetic equipment", the secretariat of which is held by BSI. It has been prepared so as to accommodate
the use of nitric oxide admixed with nitrogen as a medical gas.
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 October 2002, and conflicting national standards shall be withdrawn at the latest
by October 2002.
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).
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
REVISED TEXT
1 Scope
Add to the list of medical gases:
‘NO/N mixtures (NO £ 1000 μl/l)’
2
2 Normative references
Add the following:
‘ISO/DIS 407:2001 Small medical gas cylinders - Pin-index yoke-type valve connections’
‘EN 1089-3 Transportable gas cylinders – Cylinder identification – Part 3: Colour coding’
Delete the following:
‘ISO 554 Standard atmospheres for conditioning and/or testing – Specifications’
Change ‘ISO 5145’ to ‘ISO/DIS 5145:2001’
2

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SIST EN 738-1:2000/A1:2002
EN 738-1:1997/A1:2002 (E)
3 Definitions
Add a new definition:
‘3.29
accuracy of flow:
difference in percent between the indicated value and the true value of the flow.’
5.3.1
Add a new Note 4:
NOTE 4 ‘Guidance for the selection of metallic and non-metallic materials for use with NO/N mixtures (NO £ 1000 μl/l) is
2
given in CEN Report CR 13903.’
5.4.2.1.1
Add the following:
‘For connection to cylinders of NO/N mixtures (NO £ 1000 μl/l) the inlet connector shall conform to ISO/DIS
2
407:2001 (figure E-F) or to ISO/DIS 5145:2001 (30-RH/15,2-20,8).’
5.4.2.1.2
Add the following:
‘For pressure regulators for NO/N mixtures (NO £ 1000 μl/l) the outlet connector shall be one of the following:
2
d) a proprietary fitting permanently connected to the delivery system. If a hose is used, the hose and the
method of attachment to the proprietary fitting shall comply with EN 739.
e) a quick connector.
1)
NOTE : An example of outlet connector suitable for use with NO/N mixtures(NO £ 1000 μl/l) is the body of the quick-connector
2
"Swagelock - QC4 DESO -Stainless steel 316.’
Add footnote:
1)
‘ This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of the
product named.’
5.4.2.2
Add the following:
‘For pressure regulators for NO/N mixtures (NO £ 1000 μl/l) the rated outlet pressure shall be 400 kPa.’
2
5.4.2.5
Add t
...