EN ISO 7396-1:2007/A2:2010

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 2 (ISO 7396-1:2007/Amd 2:2010)

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: Rohrleitungenssyteme für medizinische Druckgase und Vakuum - Änderung 2 (ISO 7396-1:2007/Amd 2:2010)

Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz médicaux comprimés et de vide - Amendement 2 (ISO 7396-1:2007/Amd 2:2010)

Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske pline in podtlak - Dopolnilo A2 (ISO 7396-1:2007/Amd 2:2010)

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: 31-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/A2:2010 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 2 (ISO 7396-1:2007/Amd 2:2010)

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/oprA2:2009
01-april-2009
Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske
pline in podtlak - Dopolnilo A2 (ISO 7396-1:2007/DAM 2:2009)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum - Amendment 2 (ISO 7396-1:2007/DAM 2:2009)
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungenssyteme für
medizinische Druckgase und Vakuum - Änderung 2 (ISO 7396-1:2007/DAM 2:2009)
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz
médicaux comprimés et de vide - Amendement 2 (ISO 7396-1:2007/DAM 2:2009)
Ta slovenski standard je istoveten z: EN ISO 7396-1:2007/prA2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 7396-1:2007/oprA2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 7396-1:2007/oprA2:2009

SIST EN ISO 7396-1:2007/oprA2:2009
EUROPEAN STANDARD
DRAFT
EN ISO 7396-1:2007
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
February 2009
ICS 11.040.10
English Version
Medical gas pipeline systems - Part 1: Pipeline systems for
compressed medical gases and vacuum - Amendment 2 (ISO
7396-1:2007/DAM 2:2009)
Systèmes de distribution de gaz médicaux - Partie 1: Rohrleitungssysteme für medizinische Gase - Teil 1:
Systèmes de distribution de gaz médicaux comprimés et Rohrleitungenssyteme für medizinische Druckgase und
de vide - Amendement 2 (ISO 7396-1:2007/DAM 2:2009) Vakuum - Änderung 2 (ISO 7396-1:2007/DAM 2:2009)
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 A2, if approved, will modify the European Standard EN ISO 7396-1:2007. 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, 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7396-1:2007/prA2:2009: E
worldwide for CEN national Members.

SIST EN ISO 7396-1:2007/oprA2:2009
EN ISO 7396-1:2007/prA2:2009 (E)
Contents Page
Foreword .3

SIST EN ISO 7396-1:2007/oprA2:2009
EN ISO 7396-1:2007/prA2:2009 (E)
Foreword
This document (EN ISO 7396-1:2007/prA2:2009) 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 EC Directive(s).
Endorsement notice
The text of ISO 7396-1:2007/DAM 2:2009 has been approved by CEN as a EN ISO 7396-1:2007/prA2:2009
without any modification.
SIST EN ISO 7396-1:2007/oprA2:2009

SIST EN ISO 7396-1:2007/oprA2:2009
DRAFT AMENDMENT ISO 7396-1:2007/DAmd 2
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2009-02-12 2009-07-12
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Medical gas pipeline systems —
Part 1:
Pipeline systems for compressed medical gases and vacuum
AMENDMENT 2
Systèmes de distribution de gaz médicaux —
Partie 1: Systèmes de distribution de gaz médicaux comprimés et de vide
AMENDEMENT 2
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 FO
...

SLOVENSKI STANDARD
01-junij-2010
Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske
pline in podtlak - Dopolnilo A2 (ISO 7396-1:2007/Amd 2:2010)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum - Amendment 2 (ISO 7396-1:2007/Amd 2:2010)
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungenssyteme für
medizinische Druckgase und Vakuum - Änderung 2 (ISO 7396-1:2007/Amd 2:2010)
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz
médicaux comprimés et de vide - Amendement 2 (ISO 7396-1:2007/Amd 2:2010)
Ta slovenski standard je istoveten z: EN ISO 7396-1:2007/A2:2010
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 7396-1:2007/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2010
ICS 11.040.10
English Version
Medical gas pipeline systems - Part 1: Pipeline systems for
compressed medical gases and vacuum - Amendment 2 (ISO
7396-1:2007/Amd 2:2010)
Systèmes de distribution de gaz médicaux - Partie 1: Rohrleitungssysteme für medizinische Gase - Teil 1:
Systèmes de distribution de gaz médicaux comprimés et Rohrleitungenssyteme für medizinische Druckgase und
de vide - Amendement 2 (ISO 7396-1:2007/Amd 2:2010) Vakuum - Änderung 2 (ISO 7396-1:2007/Amd 2:2010)
This amendment A2 modifies the European Standard EN ISO 7396-1:2007; it was approved by CEN on 30 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/A2:2010: 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 on Medical devices .4

Foreword
This document (EN ISO 7396-1:2007/A2:2010) 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 Amendment to the European Standard EN ISO 7396:2007 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by August 2010, and
conflicting national standards shall be withdrawn at the latest by August 2010.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7396-1:2007/Amd 2:2010 has been approved by CEN as a EN ISO 7396-1:2007/A2:2010
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC on Medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA 1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA 1— Correspondence between this European Standard and Directive 93/42/EEC, Medical
devices
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this European Standard EU
...