EN ISO 7396-1:2007/A2:2010

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
...