EN ISO 5360:2012

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012)

ISO 5360:2012 specifies requirements, including dimensions, for agent-specific filling systems for agent-specific anaesthetic vaporizers.
ISO 5360:2012 does not specify construction materials. Because of the unique properties of desflurane, dimensions for this agent have not been specified in ISO 5360:2012.

Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2012)

Évaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2012)

L'ISO 5360:2012 spécifie les exigences, y compris les dimensions, relatives aux systèmes de remplissage spécifiques à l'agent utilisés avec des évaporateurs d'anesthésie spécifiques à l'agent.
L'ISO 5360:2012 ne spécifie pas les matériaux constitutifs utilisés. En raison des propriétés uniques du desflurane, les dimensions pour cet agent n'ont pas été spécifiées dans l'ISO 5360:2012.

Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih anestetikov (ISO 5360:2012)

Ta mednarodni standard določa zahteve, vključno z dimenzijami, za sisteme za nalivanje posebnih hlapnih anestetikov za posebne anestezijske hlapilnike (vaporizatorje). Dimenzije za ta anestetik zaradi posebnih lastnosti desflurana niso navedene v tem mednarodnem standardu.

General Information

• Status: Withdrawn
• Publication Date: 14-Jan-2012
• 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: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 5360:2012 - Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012)

Relations

• Replaces: EN ISO 5360:2009 - Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
• Effective Date: 13-Nov-2010
• Replaced By: EN ISO 5360:2016 - Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2016)
• Effective Date: 18-Feb-2015

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anestezijski hlapilniki (vaporizatorji) - Sistemi za nalivanje posebnih hlapnih anestetikov (ISO 5360:2012)Évaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2012)Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 5360:2012SIST EN ISO 5360:2012en01-april-2012SIST EN ISO 5360:2012SLOVENSKI
STANDARDSIST EN ISO 5360:20091DGRPHãþD



SIST EN ISO 5360:2012



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 5360
January 2012 ICS 11.040.10 Supersedes EN ISO 5360:2009English Version
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2012)
Évaporateurs d'anesthésie - Systèmes de remplissage spécifiques à l'agent (ISO 5360:2012)
Anästhesiemittelverdampfer - Substanzspezifische Füllsysteme (ISO 5360:2012) This European Standard was approved by CEN on 14 January 2012.
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 CEN-CENELEC Management Centre 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 CEN-CENELEC 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, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5360:2012: ESIST EN ISO 5360:2012



EN ISO 5360:2012 (E) 2 Contents Page Foreword .3Annex ZA (informative) Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices .4 SIST EN ISO 5360:2012



EN ISO 5360:2012 (E) 3 Foreword This document (EN ISO 5360:2012) 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 European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2012, and conflicting national standards shall be withdrawn at the latest by January 2015. 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 supersedes EN ISO 5360:2009. 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, Turkey and the United Kingdom. Endorsement notice The text of ISO 5360:2012 has been approved by CEN as a EN ISO 5360:2012 without any modification. SIST EN ISO 5360:2012



EN ISO 5360:2012 (E) 4 Annex ZA (informative) Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices This standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC.
Once this standa
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