Cryogenic vessels - Static non-vacuum insulated vessels - Part 2: Design, fabrication, inspection and testing

This European Standard specifies requirements for the design, fabrication, inspection and testing of static non-vacuum insulated cryogenic vessels designed for a maximum allowable pressure of more than 0,5 bar.
This European standard applies to static non-vacuum insulated cryogenic vessels for fluids as specified in EN 14197-1 and does not apply to vessels designed for toxic fluids.
For static non-vacuum insulated cryogenic vessels designed for a maximum allowable pressure of not more than 0,5 bar this European Standard may be used as a guide.

Kryo-Behälter - Ortsfeste, nicht vakuum-isolierte Behälter - Teil 2: Bemessung, Herstellung und Prüfung

Récipients cryogéniques - Récipients statiques, non isolés sous vide - Partie 2: Conception, fabrication, inspection et essais

Kriogene posode - Stabilne, vakuumsko neizolirane posode - 2. del: Konstrukcija, izdelava, nadzor in preskus

General Information

Status
Published
Publication Date
31-Dec-2006
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Jan-2007
Due Date
01-Jan-2007
Completion Date
01-Jan-2007

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Standards Content (Sample)

62A/498/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJET DE COMITÉ POUR VOTE (CDV)
Project number IEC 60601-1-8 Ed. 1.0 / A1
Numéro de projet

IEC/TC or SC: Date of circulation Closing date for voting (Voting
62A
Date de diffusion mandatory for P-members)
CEI/CE ou SC:

Date de clôture du vote (Vote
2005-05-27
obligatoire pour les membres (P))
2005-10-28
Titre du CE/SC: Aspects généraux des TC/SC Title: Common aspects of electrical
équipements utilisé en pratique médicale equipment used in medical practice
Secretary: USA
Secrétaire:
Also of interest to the following committees Supersedes document
Intéresse également les comités suivants Remplace le document
TC 62, SC 62B/C/D, TC 66, TC 76, 62A/470/DC and 62A/481/MCR
ISO/TC 106/SC 6, ISO/TC 121/SC 1 and SC 3,
ISO/TC 150/SC 6, CENELEC/TC 62
Functions concerned
Fonctions concernées
Safety EMC Environment Quality assurance
Sécurité
CEM Environnement Assurance qualité
CE DOCUMENT EST TOUJOURS À L'ÉTUDE ET SUSCEPTIBLE DE THIS DOCUMENT IS STILL UNDER STUDY AND SUBJECT TO CHANGE. IT
MODIFICATION. IL NE PEUT SERVIR DE RÉFÉRENCE. SHOULD NOT BE USED FOR REFERENCE PURPOSES.
LES RÉCIPIENDAIRES DU PRÉSENT DOCUMENT SONT INVITÉS À RECIPIENTS OF THIS DOCUMENT ARE INVITED TO SUBMIT, WITH THEIR
PRÉSENTER, AVEC LEURS OBSERVATIONS, LA NOTIFICATION DES COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF
DROITS DE PROPRIÉTÉ DONT ILS AURAIENT ÉVENTUELLEMENT WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING
CONNAISSANCE ET À FOURNIR UNE DOCUMENTATION EXPLICATIVE. DOCUMENTATION.



Titre : Amendement 1 à la CEI 60601-1-8 : Title :Amendment 1 to IEC 60601-1-8: Medical
Appareils électromédicaux – Partie 1-8: electrical equipment – Part 1-8:
Règles générales de sécurité – Norme General requirements for safety – Collateral
collatérale: Règles générales, essais et guides standard: General requirements, tests and
pour les systèmes d'alarme dans l'équipement guidance for alarm systems in medical electrical
électromédical et les systèmes électromédicaux equipment and medical electrical systems
Parallel CENELEC and ISO votes



ATTENTION ATTENTION

CDV soumis en parallèle au vote (CEI) Parallel IEC CDV/CENELEC Enquiry
et à l’enquête (CENELEC)
Copyright © 2005 International Electrotechnical Commission, IEC. All rights reserved. It is
permitted to download this electronic file, to make a copy and to print out the content for the sole
purpose of preparing National Committee positions. You may not copy or "mirror" the file or
printed version of the document, or any part of it, for any other purpose without permission in
writing from IEC.
FORM CDV (IEC) 2002-08-09

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

– 2 – 62A/498/CDV

Note d'introduction Introductory note
Après avoir pris connaissance des préoccupations relatives Taking note of the safety concern raised in the German
à la sécurité soulevées par les commentaires allemands et comments and the resolution passed at the recent meeting
de la résolution approuvée à la récente réunion du of CENELEC/TC 62 urging IEC/TC 62 to take expeditious
CENELEC/TC 62 de presser le comité technique 62 de la action to address the issue, JWG2 met and produced this
CEI à intervenir rapidement pour traiter du problème, le draft amendment. The Secretariats intend to push forward
JWG2 s'est réuni et a établi le présent projet with this amendment with the goal of obtaining approval of
d'amendement. Les Secrétariats ont l'intention de faire the National Committees and Member Bodies for the
avancer le présent amendement dans le but d'obtenir technical changes necessary to address this issue and
l'approbation des Comités Nationaux et des Organismes eliminate the impediment to harmonization of
Membres en ce qui concerne les changements techniques EN IEC 60601-1-8 in Europe. In light of comment 8 in
nécessaires pour régler ce problème et pour éviter 62A/481/MCR, the Secretariats have decided to expedite
l'empêchement de l'harmonisation de la EN IEC 60601-1-8 processing of this amendment by omitting the Committee
en Europe. A la lumière du commentaire 8 du Stage.
62A/481/MCR, les Secrétariats ont décidé d'accélérer le
processus du présent amendement en passant l'étape du
Comité.
Le Comité National français nous rappelle la décision prise
The French National Committee reminds us of the decision
aux réunions du SC 62A de Francfort en octobre 2003
taken during the SC 62A and TC 62 meetings in Frankfurt,
concernant l'alignement structurel des normes collatérales
October 2003, concerning the structural alignment of the
sur la troisième édition de la CEI 60601-1 et de la priorité
collateral standards to the third edition of IEC 60601-1 and
donnée à cet alignement. Il est dans l'intention des
the priority given to this alignment. It is the intent of the
Secrétariats responsables, avec le présent amendement
responsible Secretariats to begin work on this alignment in
qui traite de la problématique allemande, de commencer en
parallel with this amendment that addresses the German
parallèle le travail de cet alignement. Les secrétariats se
issue. The Secretariats intend to circulate this aligned
proposent de diffuser cette (seconde) édition alignée de la (second) edition of IEC 60601-1-8 following the close of the
CEI 60601-1-8 dès la clôture du vote du FDIS de la
FDIS ballot of third edition of IEC 60601-1.
troisème édition de la CEI 60601-1.
Les aspects éditoriaux émanant des Comités Nationaux et Editorial issues raised by National Committees and Member
des Organismes Membres seront traités au cours de la Bodies will be addressed in the process of preparing the
préparation de la seconde édition pour aligner de manière second edition to structurally align IEC 60601-1-8 with the
structurelle la CEI 60601-1-8 avec la troisième édition de la third edition of IEC 60601-1. Technical issues raised by
CEI 60601-1. Les aspects techniques émanant d'autres other National Committees or Member Bodies will be dealt
Comités Nationaux ou d'autres Organismes Membres with in either an amendment to the second edition, or, if
seront traités, soit dans un amendement à la seconde sufficiently extensive, in a future third edition of IEC 60601-
édition, soit, s'ils sont suffisamment importants, dans une 1-8.
future édition de la CEI 60601-1-8.

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60601-1-8 / Amend 1 (E) © IEC:2005 – 3 – 62A/498/CDV
FOREWORD
This amendment has been prepared by a Joint Working Group of IEC subcommittee 62A: Common
aspects of electrical equipment used in medical practice of IEC technical committee 62: Electrical
equipment in medical practice and ISO subcommittee SC3: Lung ventilators and related devices of ISO
technical committee 121: Anaesthetic and respiratory equipment.
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/XX/FDIS 62A/XX/RVD

Full information on the voting for the approval of this standard can be found in the report on voting
indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will remain
1
unchanged until the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch"
in the data related to the specific publication. At this date, the publication will be
− reconfirmed;
− withdrawn;
− replaced by a revised edition, or
− amended.

___________
INTRODUCTION
This amendment contains a revision to ISO IEC 60601-1-8 (first edition, 2003): Medical electrical
equipment – Part 1-8: General requirements for safety – Collateral Standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical electrical systems.
This amendment deals primarily with requirements for ALARM SYSTEMS that have global ALARM OFF or
AUDIO OFF ALARM SIGNAL inactivation states and with the requirements for REMINDER SIGNALS.
To meet needs for change, which were identified by users of this Collateral Standard, it was necessary to
amend the standard before the previously approved maintenance cycle date.

1
 The National Committees are requested to note that for this publication the maintenance result date is 2009.

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60601-1-8 / Amen
...

SLOVENSKI STANDARD
SIST EN 14197-2:2004/A1:2007
01-januar-2007
Kriogene posode - Stabilne, vakuumsko neizolirane posode - 2. del: Konstrukcija,
izdelava, nadzor in preskus
Cryogenic vessels - Static non-vacuum insulated vessels - Part 2: Design, fabrication,
inspection and testing
Kryo-Behälter - Ortsfeste, nicht vakuum-isolierte Behälter - Teil 2: Bemessung,
Herstellung und Prüfung
Récipients cryogéniques - Récipients statiques, non isolés sous vide - Partie 2:
Conception, fabrication, inspection et essais
Ta slovenski standard je istoveten z: EN 14197-2:2003/A1:2006
ICS:
23.020.40 Proti mrazu odporne posode Cryogenic vessels
(kriogenske posode)
SIST EN 14197-2:2004/A1:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

EUROPEAN STANDARD
EN 14197-2:2003/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2006
ICS 23.020.40

English Version
Cryogenic vessels - Static non-vacuum insulated vessels - Part
2: Design, fabrication, inspection and testing
Récipients cryogéniques - Récipients statiques, non isolés Kryo-Behälter - Ortsfeste, nicht vakuum-isolierte Behälter -
sous vide - Partie 2: Conception, fabrication, inspection et Teil 2: Benennung, Herstellung und Prüfung
essais
This amendment A1 modifies the European Standard EN 14197-2:2003; it was approved by CEN on 14 July 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14197-2:2003/A1:2006: E
worldwide for CEN national Members.

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

EN 14197-2:2003/A1:2006 (E)
Contents Page
Foreword.3
Introduction .4
Annex H .5

2
...

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