1、 Reference numberISO 10651-5:2006(E)ISO 2006INTERNATIONAL STANDARD ISO10651-5First edition2006-02-01Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators Ventilateurs pulmonaires usage mdical Exigences particul
2、ires pour la scurit de base et les performances essentielles Partie 5: Appareils de ranimation durgence aliments par gaz National Standard of CanadaCAN/CSA-Z10651-5-08International Standard ISO 10651-5:2006 (first edition, 2006-02-01) has been adopted with Canadiandeviations (MOD) as CSA Standard CA
3、N/CSA-Z10651-5-08, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 978-1-55436-667-5 February 2008 International Organization for Standardization (ISO), 2006. All rights reserved.NOT FOR RESALE.Legal Notice for StandardsCanadian Standards Association (
4、CSA) standards are developed through a consensus standards development process approved by the Standards Council of Canada. This process brings together volunteers representing varied viewpoints and interests to achieve consensusand develop a standard. Although CSA administers the process and establ
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18、only if this Legal Notice appears on each such copy.In addition, users may not and may not permit others to.alter this document in any way or remove this Legal Notice from the attached standard;.sell this document without authorization from CSA; or.make an electronic copy of this document.If you do
19、not agree with any of the terms and conditions contained in this Legal Notice, you may not load or use this document ormake any copies of the contents hereof, and if you do make such copies, you are required to destroy them immediately. Use of thisdocument constitutes your acceptance of the terms an
20、d conditions of this Legal Notice.Update No. 1CAN/CSA-Z10651-5-08February 2011Note: General Instructions for CSA Standards are now called Updates. Please contact CSA Information Products Sales or visit www.ShopCSA.ca for information about the CSA Standards Update Service.Title: Lung ventilators for
21、medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators originally published February 2008The following revisions have been formally approved and are marked by the symbol delta ( in the margin on the attached replacement pages:Revise
22、d Clauses 2 and 3New Annex EADeleted None Update your copy by inserting these revised pages. Keep the pages you remove for reference.Mise jour no1CAN/CSA-Z10651-5-08Fvrier 2011Note : Les notes lutilisateur aux normes CSA sont maintenant des mises jour. Veuillez communiquer avec le groupe Vente des p
23、roduits dinformation de la CSA ou rendez-vous au www.ShopCSA.ca pour plus de renseignements sur le service de mise jour des normes CSA.Titre : Ventilateurs pulmonaires usage mdical Exigences particulires pour la scurit de base et les performances essentielles Partie 5 : Appareils de ranimation durge
24、nce aliments par gaz publie initialement en fvrier 2008Les modifications qui suivent ont t officiellement approuves. Elles sont publies dans les feuilles rvises ci-jointes et sont indiques par le symbole delta ( dans la marge :Modification Chapitres 2 et 3Ajout Annexe EAAbrogation Aucune Insrez les
25、feuilles rvises dans votre exemplaire de la norme pour la tenir jour. Conservez les pages primes titre de rfrence.CAN/CSA-Z10651-5-08Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitatorsFebruary 2011CAN/CSA-Z17
26、664-06Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesCAN/CSA-Z23328-1-04Breathing system filters for anaesthetic and respiratory use Part 1: Salt test method to assess filtration performanceCAN/CSA-Z23328-2-03Breath
27、ing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspectsWhere reference is made to CSA or other publications, such reference shall be considered to refer to the latest edition and all amendments published to that edition. This Standard refers to the following publication
28、s, and the years shown indicate the latest editions available at the time of printing:CSA (Canadian Standards Association)C22.2 No. 25-1966 (R2009)Enclosures for use in Class II Groups E, F, and G hazardous locationsC22.2 No. 30-M1986 (R2007)Explosion-proof enclosures for use in Class I hazardous lo
29、cationsCAN/CSA-C22.2 No. 157-92 (R2006)Intrinsically safe and non-incendive equipment for use in hazardous locationsCAN/CSA-C22.2 No. 60601-1:08Medical electrical equipment Part 1: General requirements for basic safety and essential performanceCAN/CSA-Z94.4-02 (R2007) Selection, use, and care of res
30、piratorsCAN/CSA-Z180.1-00 (R2010)Compressed breathing air and systems3 Terms and definitionsAdd the following definition to this Clause3.10Aimmediately dangerous to life or health (IDLH)an atmosphere that poses an immediate threat to life, would cause irreversible adverse health effects, or would im
31、pair an individuals ability to escape.Note: Users should refer to Clause 5.7 of CAN/CSA-Z94.4 for guidance in determining the existence of an IDLH atmosphere.CSA/5(Replaces p. CSA/5, February 2008) Canadian Standards AssociationFebruary 2011CAN/CSA-Z10651-5-08Lung ventilators for medical use Particu
32、lar requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitatorsAdd the following annexAnnex EA (normative)Use of resuscitators in industrial environmentsNote: The circumstances of industrial rescue applications, in particular the use of resuscitators in IDLH a
33、tmospheres, have implications for the mandatory features of the device. In addition to the requirements specified in the body of this Standard, the following requirements should be considered if a resuscitator is intended for use in an industrial setting.EA.1 Use in IDLH atmospheresEA.1.1Resuscitato
34、rs intended for use in IDLH atmospheres shall not aspirate gases from the atmosphere.EA.1.2Manufacturers shall disclose the means by which aspiration of atmospheric gases is prevented and the corresponding performance characteristics.EA.2 Use in flammable or explosive environmentsEA.2.1Resuscitators
35、 containing electrical components that are intended for use in explosive environments shall be(a) intrinsically safe as specified in CAN/CSA-C22.2 No. 157; or(b) enclosed in an explosion-proof container meeting the requirements of CSA C22.2 No. 25 or CSA C22.2 No. 30.EA.2.2Resuscitators containing e
36、lectrical components that are intended for use in flammable or explosive environments shall comply with the requirements for protection against hazards of ignition of flammable anaesthetic mixtures specified in CAN/CSA-C22.2 No. 60601-1.EA.2.3Resuscitators intended for use in flammable environments
37、shall meet the following requirements:(a) The device shall be capable of utilizing compressed air meeting the requirements of CAN/CSA-Z180.1.(b) The performance characteristics of the device (see Clause 7 of this Standard) shall not be significantly affected by the use of compressed air. The operato
38、rs manual shall indicate any changes resulting from the use of compressed air.Note: It should be determined whether operation of the device at high oxygen concentration presents an unacceptable risk. Use of an adult bag-valve without pressure-limiting systems for neonates can cause barotrauma due to
39、 overinflation. Use of a bag-valve-mask assembly appropriate to the patients size is recommended.EA.3 Positive pressure/mask flushIf a face mask is employed, the manufacturer shall disclose the means by which the entrainment of atmospheric gases into the face mask is prevented.Note: Means to accompl
40、ish this may, for example, involve maintaining a constant flow of gas going into the mask or, alternatively, maintaining a positive pressure in the mask.(Replaces p. CSA/6, February 2008)CSA/6 Canadian Standards AssociationCAN/CSA-Z10651-5-08Ventilateurs pulmonaires usage mdical Exigences particulir
41、es pour la scurit de base et les performances essentielles Partie 5 : Appareils de ranimation durgence aliments par gazExigences propres au Canada2 Rfrences normativesAjouter ce qui suitCes Normes nationales du Canada, publies par lAssociation canadienne de normalisation, sont une adoption de normes
42、 CEI et ISO. Ces normes CSA ont prsance sur les Normes internationales dont elles sont inspires ; toute rfrence dans la CAN/CSA-Z10651-5 la Norme internationale doit tre remplace par une rfrence la norme canadienne quivalente.CAN/CSA-C22.2 n 601.1-M90 (confirme en 2005)Appareils lectromdicaux Premir
43、e partie : Rgles gnrales de scuritCAN/CSA-C22.2 n 60529:05Degrs de protection procurs par les enveloppes (Code IP)CAN/CSA-ISO 11134-98 (confirme en 2003)Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilizationCAN/CSA-ISO 11135-98 (conf
44、irme en 2003)Dispositifs mdicaux Validation et contrle de routine de la strilisation loxyde dthylneCAN/CSA-ISO 11137-98 (confirme en 2003)Strilisation des dispositifs mdicaux Prescriptions pour la validation et le contrle de routine Strilisation par irradiationCAN/CSA-ISO 14937-01 (confirme en 2006)
45、Strilisation des produits de sant Exigences gnrales pour la caractrisation dun agent strilisant et pour le dveloppement, la validation et la vrification de routine dun processus de strilisation pour dispositifs mdicauxCAN/CSA-ISO 14971:07 Dispositifs mdicaux Application de la gestion des risques aux
46、 dispositifs mdicauxCAN/CSA-Z5356-1-08Matriel danesthsie et de ranimation respiratoire Raccords coniques Partie 1 : Raccords mles et femellesCAN/CSA-Z5356-2-08Matriel danesthsie et de ranimation respiratoire Raccords coniques Partie 2 : Raccords vis supportant un certain poidsCAN/CSA-Z5359-04Low-pre
47、ssure hose assemblies for use with medical gasesCAN/CSA-Z9170-1-00 (confirme en 2005)Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuumFvrier 2011(Remplace p. CSA/F1, fvrier 2008) Association canadienne de normalisation CSA/F1CAN/C
48、SA-Z10651-5-08Ventilateurs pulmonaires usage mdical Exigences particulires pour la scurit de base et les performances essentielles Partie 5 : Appareils de ranimation durgence aliments par gazCAN/CSA-Z10651-3-98 (confirme en 2003)Lung ventilators for medical use Part 3: Particular requirements for em
49、ergency and transport ventilatorsCAN/CSA-Z11138-1-07Strilisation des produits de sant Indicateurs biologiques Partie 1 : Exigences gnralesCAN/CSA-Z17664-06Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesCAN/CSA-Z23328-1-04Breathing system filters for
