EN ISO 11197:2004

Medical supply units (ISO 11197:2004)

2004-07-29 (LUP):  The draft is recorded for submission to FV on 2004-06-17. FV closes on  2048-08-17. Hence the corresponding WI number has to be removed from the list proposed for deletion under BT 32/2004. For details please contact responsible Programme Manager. Ludwig Paul: [phone] or email [e-mail]
TC215 sent the text on 9 May 2003 to CMC for parallel FV issue and it was approved by the CEN consultant on 13 June 2003. CMC who informed TC 215 that he the document had to be with ISO/CS and he would prompt ISO for action on 1 March 2004
The ISO SC has been contacte and is looking to the reason why no formal reply was given to the CMC production departement. By the mean time the CMC production confirm that they still have the draft and reinitiated the request to ISO for processing the vote (see list of questions given to STDDEV sector management for resolutions in coordination meeting with CMC production). (LP 2004-05-18)

Medizinische Versorgungseinheiten (ISO 11197:2004)

Abschnitt 1 der EN 60601-1:1990 gilt mit folgenden Abweichungen:
Diese Norm gilt für medizinische Versorgungseinheit nach 3.5.
Diese Besonderen Festlegungen gelten zusammen mit denen der EN 60601-1.
Die Anforderungen dieser Besonderen Norm haben Vorrang vor denen der EN 60601-1.

Gaines techniques à usage médical (ISO 11197:2004)

L'article 1 de l'EN 60601-1:1990 s'applique en ajoutant les éléments suivants :
Le présent document s'applique aux gaines techniques à usage médical définies au paragraphe 3.5.
Le présent document s'applique conjointement à la norme EN 60601-1.
Les exigences du présent document prévalent sur celles de la norme EN 60601-1.

Enote za oskrbo v medicini (ISO 11197:2004)

General Information

• Status: Withdrawn
• Publication Date: 14-Dec-2004
• Withdrawal Date: 14-Apr-2009
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Apr-2009
• Completion Date: 15-Apr-2009
• 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 11197:2005 - Medical supply units (ISO 11197:2004)

Relations

• Replaces: EN 793:1997 - Particular requirements for safety of medical supply units
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11197:2009 - Medical supply units (ISO 11197:2004)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11197:2005
01-marec-2005
Enote za oskrbo v medicini (ISO 11197:2004)
Medical supply units (ISO 11197:2004)
Medizinische Versorgungseinheiten (ISO 11197:2004)
Gaines techniques a usage médical (ISO 11197:2004)
Ta slovenski standard je istoveten z: EN ISO 11197:2004
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 11197:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11197:2005

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SIST EN ISO 11197:2005



EUROPEAN STANDARD
EN ISO 11197

NORME EUROPÉENNE

EUROPÄISCHE NORM
December 2004
ICS 11.040.01 Supersedes EN 793:1997
English version
Medical supply units (ISO 11197:2004)
Gaines techniques à usage médical (ISO 11197:2004) Medizinische Versorgungseinheiten (ISO 11197:2004)
This European Standard was approved by CEN on 23 September 2004.

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 lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.

This European Standard 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, 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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11197:2004: E
worldwide for CEN national Members.

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SIST EN ISO 11197:2005
EN ISO 11197:2004 (E)
Contents
page
Foreword.5
Introduction .6
SECTION ONE - GENERAL .7
1 Scope .7
2 Normative references .7
3 Terms and definitions .8
4 General requirements and requirements for tests.8
5 Classification.9
6 Identification, marking and documents.9
7 Power input .13
SECTION TWO - ENVIRONMENTAL CONDITIONS .14
8 Basic safety categories.14
9 Removable protection means.14
10 Environmental conditions.14
11 Not Used .14
12 Not Used .14
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS.15
13 General.
...