EN ISO 7396-1:2007/A1:2010

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1: Requirements for terminal units for vacuum fitted on medical supply units with operator-adjustable portions and connected to the pipeline through flexible hoses (ISO 7396-1:2007/Amd 1:2010)

This part of ISO 7396 specifies requirements for design, installation, function, performance, documentation, testing and commissioning of pipeline systems for compressed medical gases, gases for driving surgical tools and vacuum in healthcare facilities to ensure continuous delivery of the correct gas and the provision of vacuum from the pipeline system. It includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems. This part of ISO 7396 is applicable to: a) pipeline systems for the following medical gases: - oxygen; - nitrous oxide; - medical air; - carbon dioxide; - oxygen/nitrous oxide mixtures (see Note 1); b) pipeline systems for the following gases: - oxygen-enriched air; - air for driving surgical tools; - nitrogen for driving surgical tools; c) pipeline systems for vacuum. This part of ISO 7396 also applies to: - extensions of existing pipeline distribution systems; - modifications of existing pipeline distribution systems; - modifications or replacement of supply systems or sources of supply.

Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für medizinische Druckgase und Vakuum - Änderung 1: Anforderungen an Entnahmestellen für Vakuum, die an medizinische Versorgungseinheiten mit vom Anwender einstellbaren Abschnitten angebracht und durch flexibles Schläuche mit der Rohrleitung verbunden sind (ISO 7396-1:2007/Amd 1:2010)

Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz médicaux comprimés et de vide - Amendement 1: Exigences relatives aux prises murales pour le vide montées sur des gaines techniques médicales munies de sections réglables par l'opérateur et raccordées aux canalisations par des flexibles (ISO 7396-1:2007/Amd 1:2010)

Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske pline in podtlak - Dopolnilo 1: Zahteve za terminalne enote vakuumskih sesalnikov za medicinsko oskrbo z nastavljivimi deli in gibljivimi cevmi za povezavo s plinovodom (ISO 7396-1:2007/Amd 1:2010)

Ta del ISO 7396 določa zahteve za načrt, namestitev, delovanje, dokumentacijo, preskušanje in usposobitev za zagon sistemov napeljav za stisnjene medicinske pline, pline za pogon kirurškega orodja in vakuum v zdravstvenih ustanovah, ki iz sistema napeljave zagotavljajo neprekinjeno oskrbo s pravim plinom in dovajanje vakuuma. Vključuje zahteve za sisteme oskrbe, cevovodne distribucijske sisteme, nadzorne sisteme, sisteme za spremljanje in alarm ter neizmenljivost med sestavnimi deli različnih plinskih sistemov. Ta del ISO 7396 velja za: a) sisteme napeljav za naslednje medicinske pline: - kisik; - dušikov oksid; - medicinski zrak; - ogljikov dioksid; - mešanice kisika/dušikovega oksida (glej Opombo 1); b) sisteme napeljav za naslednje pline: - s kisikom obogateni zrak; - zrak za pogon kirurškega orodja; - dušik za pogon kirurškega orodja; c) sisteme napeljav za vakuum. Ta del ISO 7396 velja tudi za: - podaljške obstoječih distribucijskih cevovodnih sistemov; - spremembe obstoječih distribucijskih cevovodnih sistemov; - spremembe ali zamenjavo sistemov oskrbe ali virov oskrbe.

General Information

• Status: Withdrawn
• Publication Date: 14-Jan-2010
• Withdrawal Date: 15-Mar-2016
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• 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: 16-Mar-2016
• 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 7396-1:2007/A1:2010 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 1: Requirements for terminal units for vacuum fitted on medical supply units with operator-adjustable portions and connected to the pipeline through flexible hoses (ISO 7396-1:2007/Amd 1:2010)

Relations

• Replaced By: EN ISO 7396-1:2016 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
• Effective Date: 23-Mar-2016
• Amends: EN ISO 7396-1:2007 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7396-1:2007/A1:2010
01-julij-2010
Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske
pline in podtlak - Dopolnilo 1: Zahteve za terminalne enote vakuumskih sesalnikov
za medicinsko oskrbo z nastavljivimi deli in gibljivimi cevmi za povezavo s
plinovodom (ISO 7396-1:2007/Amd 1:2010)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum - Amendment 1: Requirements for terminal units for vacuum fitted on
medical supply units with operator-adjustable portions and connected to the pipeline
through flexible hoses (ISO 7396-1:2007/Amd 1:2010)
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für
medizinische Druckgase und Vakuum - Änderung 1: Anforderungen an Entnahmestellen
für Vakuum, die an medizinische Versorgungseinheiten mit vom Anwender einstellbaren
Abschnitten angebracht und durch flexibles Schläuche mit der Rohrleitung verbunden
sind (ISO 7396-1:2007/Amd 1:2010)
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz
médicaux comprimés et de vide - Amendement 1: Exigences relatives aux prises
murales pour le vide montées sur des gaines techniques médicales munies de sections
réglables par l'opérateur et raccordées aux canalisations par des flexibles (ISO 7396-
1:2007/Amd 1:2010)
Ta slovenski standard je istoveten z: EN ISO 7396-1:2007/A1:2010
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 7396-1:2007/A1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 7396-1:2007/A1:2010

---------------------- Page: 2 ----------------------

SIST EN ISO 7396-1:2007/A1:2010


EUROPEAN STANDARD
EN ISO 7396-1:2007/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
January 2010
ICS 11.040.10
English Version
Medical gas pipeline systems - Part 1: Pipeline systems for
compressed medical gases and vacuum - Amendment 1:
Requirements for terminal units for vacuum fitted on medical
supply units with operator-adjustable portions and connected to
the pipeline through flexible hoses (ISO 7396-1:2007/Amd
1:2010)
Systèmes de distribution de gaz médicaux - Partie 1: Rohrleitungssysteme für medizinische Gase - Teil 1:
Systèmes de distribution de gaz médicaux comprimés et Rohrleitungssysteme für medizinische Druckgase und
de vide - Amendement 1: Exigences relatives aux prises Vakuum - Änderung 1: Anforderungen an Entnahmestellen
murales pour le vide montées sur des gaines techniques für Vakuum, die an medizinische Versorgungseinheiten mit
médicales munies de sections réglables par l'opérateur et vom Anwender einstellbaren Abschnitten angebracht und
raccordées aux canalisations par des flexibles (ISO 7396- durch flexibles Schläuche mit der Rohrleitung verbunden
1:2007/Amd 1:2010) sind (ISO 7396-1:2007/Amd 1:2010)
This amendment A1 modifies the European Standard EN ISO 7396-1:2007; it was approved by CEN on 9 January 2010.

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 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 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.






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 7396-1:2007/A1:2010: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 7396-1:2007/A1:2010
EN ISO 7396-1:2007/A1:2010 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices .
...