EN ISO 15001:2011
(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, Bau¬teilen 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 Risiko-analysen 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 Zerfalls-produkten 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, medizi¬nische 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)
ISO 15001:2010 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 ISO 15001:2010 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 proizvodov izgorevanja in/ali razgradnje.
Vidiki združljivosti, ki jih obravnava ISO 15001:2010, vključujejo čistočo, odpornost proti vžigu in toksičnost proizvodov izgorevanja in/ali razgradnje v fazah načrtovanja, izdelave, vzdrževanja in odlaganja.
ISO 15001:2010 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
Relations
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 de réanimation 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 15001:2011SIST EN ISO 15001:2012en01-januar-2012SIST EN ISO 15001:2012SLOVENSKI
STANDARDSIST EN ISO 15001:20101DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 15001
October 2011 ICS 11.040.40 Supersedes EN ISO 15001:2010English 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 20 September 2011.
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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15001:2011: ESIST EN ISO 15001:2012
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 15001:2012
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 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 Essential Requirements of the New Approach Directive 93/42/EEC Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Medical Devices Clause(s)/subclause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes
This standard specifies minimum requirements for the oxygen compatibility of materials components and devices that can come into contact with oxygen in normal or single fault condition. All its requirements aim at minimising the risk of fire/oxidation and the consequences to the patients treated by devices connected to the concerned pipeline/devices system. 4, 5, 6 7.1 first indent Risks other than risks to patients resulting from combustion/oxidation are not addressed. 4, 5, 6 7.3 Only for aspects of oxygen compatibility. 4, 5, 6 9.2 first indent Only risks of injury linked with sudden increase of pressure, temperature due to fire are covered. 4, 5, 6 9.3 Only for aspects of oxygen compatibility.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
Reference numberISO 15001:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO15001Second edition2010-06-01Anaesthetic and respiratory equipment —Compatibility with oxygen Matériel d'anesthésie et de réanimation respiratoire — Compatibilité avec l'oxygène
ISO 15001:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ii © ISO 2010 – All rights reserved
ISO 15001:2010(E) © ISO 2010 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1* Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Cleanliness.2 5* Resistance to ignition.3 6 Risk management.3 Annex A (informative)
Examples of cleaning procedures.4 Annex B (informative)
Typical methods for validation of cleaning procedures.11 Annex C (informative)
Design considerations.14 Annex D (informative)
Selection of materials.19 Annex E (informative)
Recommended method for combustion and quantitative analysis of combustion products of non-metallic materials.32 Annex F (informative)
Rationale.37 Bibliography.38
ISO 15001:2010(E) iv © ISO 2010 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15001 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems. This second edition cancels and replaces the first edition (ISO 15001:2003), subclauses of which have been technically revised. SIST EN ISO 15001:2012
ISO 15001:2010(E) © ISO 2010 – All rights reserved v Introduction Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and clinical personnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a fire occurs in an oxygen-enriched atmosphere. A common cause of fire is the heat produced by adiabatic compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some combustion products, especially some non-metals (e.g. plastics, elastomers and lubricants) are toxic and thus patients remote from that equipment and who are receiving oxygen from a medical gas pipeline system might be injured when a problem occurs. Other equipment which is in close proximity to the equipment using oxygen, or that utilizes oxygen as its source of power, can be damaged or fail to function properly if there is a problem with the oxygen equipment. Reduction or avoidance of these risks depends on the choice of appropriate materials, cleaning procedures and correct design and construction of equipment so that it is compatible with oxygen under the conditions of use. This International Standard gives recommendations for the selection of materials and the cleaning of components made from them, for use in oxygen and oxygen-enriched atmospheres. Annex F contains rationale statements for some of the requirements of this International Standard. It is included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated into this International Standard. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale contained in Annex F. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite any subsequent revisions. It is expected that particular device standards will make reference to this horizontal International Standard and may, if appropriate, strengthen these minimum requirements. Particular device standards may specify that some requirements of this International Standard may apply for medical gases other than oxygen.
INTERNATIONAL STANDARD ISO 15001:2010(E) © ISO 2010 – All rights reserved 1 Anaesthetic and respiratory equipment — Compatibility with oxygen 1* Scope This International Standard specifies requirements for the oxygen compatibility of materials, components an
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