EN ISO 15001:2010
(Main)Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
ISO 15001:2010 specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa.
Additionally, ISO 15001:2010 gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition.
Aspects of compatibility that are addressed by ISO 15001:2010 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.
ISO 15001:2010 is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.
Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2010)
Diese Internationale Norm legt Anforderungen an die Sauerstoffverträglichkeit von Werkstoffen, Bauteilen und
Geräten für Anwendungen bei der Anästhesie und Beatmung fest, die im Normalzustand oder beim Ersten
Fehler mit Sauerstoff bei Drücken über 50 kPa in Berührung kommen können.
Zusätzlich enthält diese Internationale Norm allgemeine Leitlinien für die Wahl der Werkstoffe und Bauteile auf
der Grundlage der vorhandenen Daten zur Sauerstoffverträglichkeit und für die Durchführung von Risikoanalysen
einschließlich der Toxizitätsbenennung von Verbrennungs- und/oder Zerfallsprodukten.
Zu den in dieser Internationalen Norm behandelten Gesichtspunkten der Verträglichkeit gehören die
Sauberkeit, die Widerstandsfähigkeit gegen Zündung und die Toxizität von Verbrennungs- und/oder Zerfallsprodukten
bei Konstruktion, Herstellung, Instandhaltung und Entsorgung.
Diese Internationale Norm gilt nicht für die Biokompatibilität.
Diese Internationale Norm gilt für Anästhesie- und Beatmungsgeräte, die innerhalb des Aufgabenbereichs des
ISO/TC 121 liegen, z. B. Rohrleitungssysteme für medizinische Gase, Druckminderer, Entnahmestellen,
medizinische Versorgungseinheiten, flexible Verbindungsstücke, Durchflussmessgeräte, Anästhesie-
Arbeitsplätze und Lungenbeatmungsgeräte.
Matériel d'anesthésie et de réanimation respiratoire - Compatibilité avec l'oxygène (ISO 15001:2010)
L'ISO 15001:2010 spécifie les exigences relatives à la compatibilité de l'oxygène des matériaux, des composants et des appareils pour les applications anesthésiques et respiratoires qui peuvent entrer en contact avec l'oxygène en condition normale ou en condition de premier défaut à des pressions de gaz supérieures à 50 kPa.
De plus, l'ISO 15001:2010 donne des lignes directrices générales pour la sélection des matériaux et des composants fondées sur des données disponibles sur leur compatibilité d'oxygène, et pour effectuer une analyse de risque, y compris l'adressage de la toxicité des produits de la combustion et/ou de la décomposition.
Les aspects de la compatibilité qui sont abordés dans l'ISO 15001:2010 incluent la propreté, la résistance à l'inflammation et la toxicité des produits de combustion et/ou de décomposition lors de la conception, de la fabrication, de la maintenance et des étapes d'élimination.
L'ISO 15001:2010 est applicable aux équipements anesthésiques et respiratoires qui entrent dans le champ d'application de l'ISO/TC 121, par exemple les systèmes de distribution de gaz médicaux, les détendeurs, les prises murales, les gaines techniques pour usage médical, les flexibles haute pression, les débitmètres, les systèmes d'anesthésie et les ventilateurs pulmonaires.
Anestezijska in respiratorna oprema - Združljivost s kisikom (ISO 15001:2010)
Ta mednarodni standard določa zahteve za združljivost s kisikom za materiale, sestavne dele in pripomočke za anestezijo in dihanje, ki lahko pridejo v stik s kisikom v normalnih okoliščinah ali v primeru ene same napake pri tlakih plina, višjih od 50 kPa. Poleg tega ta mednarodni standard podaja splošne smernice za izbor materialov in sestavnih delov na osnovi razpoložljivih podatkov o njihovi združljivosti s kisikom in za izvedbo analize tveganja, vključno z obravnavo toksičnosti produktov izgorevanja in/ali razgradnje. Vidiki združljivosti, ki jih obravnava ta mednarodni standard, vključujejo čistočo, odpornost proti vžigu in toksičnost produktov izgorevanja in/ali razgradnje v fazah načrtovanja, izdelave, vzdrževanja in odlaganja. Ta mednarodni standard ne velja za biološko združljivost. Ta mednarodni standard velja za anestezijsko in dihalno opremo, ki spada v področje uporabe ISO/TC 121, npr. cevovodne sisteme za medicinske pline, tlačne regulatorje, terminalne enote, enote za medicinsko oskrbo, gibljive konektorje, pripomočke za merjenje pretoka, anestezijske delovne postaje in pljučne ventilatorje.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Anestezijska in respiratorna oprema - Združljivost s kisikom (ISO 15001:2010)Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2010)Matériel d'anesthésie et respiratoire - Compatibilité avec l'oxygène (ISO 15001:2010)Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 15001:2010SIST EN ISO 15001:2010en01-oktober-2010SIST EN ISO 15001:2010SLOVENSKI
STANDARDSIST EN ISO 15001:20041DGRPHãþD
SIST EN ISO 15001:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 15001
June 2010 ICS 11.040.10 Supersedes EN ISO 15001:2004English Version
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
Matériel d'anesthésie et de réanimation respiratoire - Compatibilité avec l'oxygène (ISO 15001:2010)
Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2010) This European Standard was approved by CEN on 26 May 2010.
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 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 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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15001:2010: ESIST EN ISO 15001:2010
EN ISO 15001:2010 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 2007/47/EC .4 SIST EN ISO 15001:2010
EN ISO 15001:2010 (E) 3 Foreword This document (EN ISO 15001:2010) 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 December 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. 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 15001:2004. 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 and the United Kingdom. Endorsement notice The text of ISO 15001:2010 has been approved by CEN as a EN ISO 15001:2010 without any modification. SIST EN ISO 15001:2010
EN ISO 15001:2010 (E) 4 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 2007/47/EC
This European 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 Ess
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