1、DEUTSCHE NORM No part of this standard may be reproduced without the prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).June 2005DIN EN ISO 18779English price group 16 www.din.
2、de www.beuth.de11.05 9653021Continued overleaf.Document comprises 35 pages.Medical devices for conserving oxygen and oxygen mixturesParticular requirements(ISO 18779:2005)English version of DIN EN ISO 18779Dosiersysteme fr Sauerstoff und Sauerstoffgemische Besondere Anforderungen (ISO 18779:2005)Nat
3、ional forewordThis standard has been published in accordance with a decision taken by CEN/TC 215 Respiratory and anaesthetic equipment to adopt, without alteration, International Standard ISO 18779 as a European Stand-ard.The responsible German body involved in its preparation was the Normenausschus
4、s Rettungsdienst und Krankenhaus (First Aid Services and Hospital Standards Committee), Technical Committee Ansthesie und Beatmung.The DIN Standards corresponding to the International Standards referred to in clause 2 of the EN are as follows:IEC/ISO Standard DIN StandardIEC 60068-2-32 DIN EN 60068-
5、2-32IEC 60068-2-64 DIN EN 60068-2-64IEC 60529 DIN EN 60529 (VDE 0470-1)IEC 60601-1 DIN EN 60601-1 (VDE 0750-1)IEC 60601-1-2 DIN EN 60601-1-2 (VDE 0750-1-2)IEC 60601-1-8 DIN EN 60601-1-8 (VDE 0750-1-8)ISO 4135 DIN EN ISO 4135ISO 15001 DIN EN ISO 15001ICS 11.040.10National Annex NA(informative)Bibliog
6、raphyDIN EN 60068-2-32 Basic environmental testing procedures Part 2: Tests Test Ed: Free fall (IEC 60068-2-32:1975 + A1:1982 + A2:1990)DIN EN 60068-2-64 Environmental testing Part 2: Test methods Test Fh: Vibration, broad-band random (digital control) and guidance (IEC 60068-2-64:1993 + Cor-rigendu
7、m 1993)DIN EN 60529 (VDE 0470-1) Degrees of protection provided by enclosures (IP code) (IEC 60529:1989 + A1:1999)DIN EN 60601-1 (VDE 0750-1) Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 62A/449/CDV:2004)DIN EN 60601-1-2 (VDE 0750-1-2) Med
8、ical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests (IEC 60601-1-2:2001)DIN EN 60601-1-8 (VDE 0750-1-8) Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requir
9、ements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2003)DIN EN ISO 4135 Anaesthesiology Vocabulary (ISO 4135:1995)DIN EN ISO 15001 Anaesthetic and respiratory equipment Compatibility with oxygen (ISO 15001:2003)Page 2 DIN EN ISO
10、 18779:2005-06English versionICS 11.040.10Management Centre: rue de Stassart, 36 B-1050 BrusselsEuropean Committee for StandardizationComit Europen de NormalisationEuropisches Komitee fr Normung 2005. CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national mem
11、bers.Ref. No. EN ISO 18779:2005 EEN ISO 18779February 2005Medical devices for conserving oxygen and oxygen mixturesParticular requirements(ISO 18779:2005)Economiseurs mdicaux doxygne et de mlanges oxygns Exigences particulires (ISO 18779:2005)Dosiersysteme fr Sauerstoff und Sauerstoffgemische Besond
12、ere Anforderungen (ISO 18779:2005)This European Standard was approved by CEN on 2005-01-28.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.Up-to-date li
13、sts and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member.The European Standards exist in three ofcial versions (English, French, German). A version in any other language made by translation under the responsibi
14、lity of a CEN member into its own language and notied to the Management Centre has the same status as the ofcial versions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Ital
15、y, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom.Page 2 EN ISO 18779:2005ForewordInternational StandardISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular require
16、ments,which was prepared by ISO/TC 121 Anaesthetic and respiratory equipment of the International Organization for Standardization, has been adopted by Technical Committee CEN/TC 215 Respiratory and anaesthetic equipment, the Secretariat of which is held by BSI, as a European Standard.This European
17、Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, and conicting national standards withdrawn, by August 2005 at the latest.In accordance with the CEN/CENELEC Internal Regulations, the national standards organizations of the follo
18、w-ing countries are bound to implement this European Standard:Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Slo-vakia, Slovenia, Spai
19、n, Sweden, Switzerland, and the United Kingdom.Endorsement noticeThe text of the International Standard ISO 18779:2005 was approved by CEN as a European Standard without any modication.For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.Page 3
20、EN ISO 18779:200525667888131313141414141415151515151515161616161616161717171717Page 4 EN ISO 18779:200517171717171718181818181920202020202021212121212122222224272930Page 5 EN ISO 18779:2005Page 6 EN ISO 18779:2005Page 7 EN ISO 18779:2005Page 8 EN ISO 18779:2005Page 9 EN ISO 18779:2005Page 10 EN ISO
21、18779:2005Page 11 EN ISO 18779:2005Page 12 EN ISO 18779:2005Page 13 EN ISO 18779:2005Page 14 EN ISO 18779:2005Page 15 EN ISO 18779:2005Page 16 EN ISO 18779:2005Page 17 EN ISO 18779:2005Page 18 EN ISO 18779:2005Page 19 EN ISO 18779:2005Page 20 EN ISO 18779:2005Page 21 EN ISO 18779:2005Page 22 EN ISO 18779:2005Page 23 EN ISO 18779:2005Page 24 EN ISO 18779:2005Page 25 EN ISO 18779:2005Page 26 EN ISO 18779:2005Page 27 EN ISO 18779:2005Page 28 EN ISO 18779:2005
