SIST EN 15908:2010
(Main)Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
This European Standard specifies requirements for connectors intended for use with medical gases. This European Standard specifies the dimensions and the allocation of non-interchangeable screwthreaded (NIST) connectors intended to be used at nominal operating pressures not greater than 1 400 kPa. The information to be supplied by the manufacturer is excluded from the scope of this European Standard because information about the use of NIST connectors is supplied by the manufacturer of each medical device to which the connectors are permanently fitted.
Anästhesie- und Beatmungsgeräte - Nichtverwechselbare Verbindungsstücke mit Schraubgewinde (NIST) für niedrigen Druck
1.1 Diese Europäische Norm legt die Anforderungen an Verbindungsstücke zur Verwendung mit medizinischen Gasen fest.
1.2 Diese Europäische Norm legt die Maße und die Zuordnung von nichtverwechselbaren Verbindungsstücken mit Schraubgewinde (NIST) fest.
ANMERKUNG Wie in EN ISO 5359 angegeben, werden Schnellverbindungsstücke nach EN ISO 9170-1 als Alternative zu NIST-Verbindungsstücken angesehen.
1.3 Diese Verbindungsstücke sind zur Verwendung bei einem Nenn-Betriebsdruck von nicht mehr als 1 400 kPa vorgesehen.
Matériel respiratoire et anesthésique - Raccords à tête filetée non interchangeables (NIST) à basse pression pour gaz médicaux
1.1 La présente Norme européenne spécifie les exigences requises pour les raccords destinés à être utilisés avec les gaz médicaux.
1.2 La présente Norme européenne spécifie les dimensions et l’affectation des raccords à tête filetée non interchangeables (NIST)
NOTE Comme indiqué dans l’EN ISO 5359, les raccords de prise rapide spécifiques à un gaz conformes à l’EN ISO 9170-1 sont considérés comme une alternative aux raccords NIST.
1.3 Ces raccords sont destinés à être utilisés à des pressions nominales de service inférieures ou égales à 1400 kPa.
Anestezijska in dihalna oprema - Nizkotlačni priključki z navojem, ki se ne menjajo (NIST)
Ta evropski standard določa zahteve za priključke, namenjene za uporabo pri medicinskih plinih. Ta evropski standard določa mere in dodeljevanje priključkov z navojem, ki se ne menjajo (NIST), namenjenim za uporabo pri nazivnih obratovalnih tlakih, ki ne presegajo 1400 kPa. Informacije, ki jih priskrbi proizvajalec, so izključene iz področja uporabe tega evropskega standarda, ker informacije o uporabi NIST priključkov priskrbi proizvajalec vsake medicinske naprave, na katero so priključki stalno nameščeni.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.1,67Anästhesie- und Beatmungsgeräte - Nichtverwechselbare Verbindungsstücke mit Schraubgewinde (NIST) für niedrigen DruckMatériel respiratoire et anesthésique - Raccords à tête filetée non interchangeables (NIST) à basse pression pour gaz médicauxAnaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 15908:2010SIST EN 15908:2010en,fr,de01-december-2010SIST EN 15908:2010SLOVENSKI
STANDARD
SIST EN 15908:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15908
October 2010 ICS 11.040.10 English Version
Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
Matériel respiratoire et anesthésique - Raccords basse pression à tête filetée non interchangeables (NIST) pour gaz médicaux
Anästhesie- und Beatmungsgeräte - Nichtverwechselbare Verbindungsstücke mit Schraubgewinde (NIST) für niedrigen Druck zur Verwendung mit medizinischen GasenThis European Standard was approved by CEN on 28 August 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 15908:2010: ESIST EN 15908:2010
FprEN 15908:2010 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Terms and definitions .54General requirements .54.1Safety .54.2Materials .64.3Design, dimensions and allocation of NIST connectors .65Marking . 146Test for durability of markings . 14Annex A (informative)
Environmental aspects . 16Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices . 17Bibliography . 18
SIST EN 15908:2010
EN 15908:2010 (E) 3 Foreword This document (EN 15908:2010) has been prepared by 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 April 2011, and conflicting national standards shall be withdrawn at the latest by April 2011. 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 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Requirements for non-interchangeable screw-threaded (NIST) connectors are currently specified in
EN ISO 5359:2008. The requirements for NIST connectors in EN 15908 are identical to those currently given in EN ISO 5359:2008 except for: the allocation of connector B11 (allocated to carbon dioxide instead to carbon dioxide/oxygen mixture [CO2 > 7 % (volume fraction)]); the allocation of connector C 19 (allocated to carbon dioxide/oxygen mixture [CO2 > 7 % (volume fraction)] instead to carbon dioxide). It is intended that EN ISO 5359:2008 will be revised so as to delete the requirements for NIST connectors. The requirements for NIST connectors in EN 15908 are identical to those given in EN 739:1998 (cancelled and replaced by EN ISO 5359:2008) except for: the allocations of connectors B11 (allocated to carbon dioxide only); the allocation of connector C19 (allocated to carbon dioxide/oxygen mixture [CO2 > 7 % (volume fraction)] only); the allocation of connector B12 to oxygen-enriched air; the allocation of connector B15 to helium/oxygen mixture [O2 < 20 % (volume fraction)] only; the allocation of connector C20 to helium only. 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.
SIST EN 15908:2010
EN 15908:2010 (E) 4 Introduction This European Standard has been prepared in response to the need for a safe method of connecting medical equipment intended to administer medical gases to patients. Medical gases are stored in cylinders or cryogenic vessels, or can be produced on site; several medical devices, e.g. pressure regulators, hose assemblies, flow-metering devices, lung ventilators, anaesthetic workstations can be fitted between the source of supply and the patient. At each interface gas-specific connectors are needed to ensure that the intended medical gas is administered to the patient. While recognizing that no system is absolutely safe, this European Standard includes those requirements considered necessary to prevent foreseeable hazards arising from the use of connectors. Operators should be continually alert to the possibility of damage being caused by external factors, and therefore regular inspection should be undertaken to ensure that connectors continue to meet the requirements of this European Standard. The choice of a single system of connectors to be used within the European Union will minimize the risks of cross connections and misconnections and ensure the free movement of medical devices intended to administer medical gases to patients. SIST EN 15908:2010
EN 15908:2010 (E) 5 1 Scope 1.1 This European Standard specifies requirements for connectors intended for use with medical gases. 1.2 This European Standard specifies the dimensions and the allocation of non-interchangeable screw-threaded (NIST) connectors intended to be used at nominal operating pressures not greater than 1 400 kPa. NOTE As stated in EN ISO 5359, gas-specific quick-connectors conforming to EN ISO 9170-1 are considered as an alternative to NIST connectors. 1.3 The information to be supplied by the manufacturer is excluded from the scope of this European Standard because information about the use of NIST connectors is supplied by the manufacturer of each medical device to which the connectors are permanently fitted. 2 Normative references The following referenced document is indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN ISO 14971, Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 gas-specific having characteristics which prevent interchangeability, thereby allowing assignment to only one gas service or vacuum service 3.2 medical gas gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic purposes, or for surgical tool applications NOTE For the purposes of this European Standard, this term includes vacuum, air and nitrogen for driving surgical tools. 3.3 NIST connector non-interchangeable screw-th
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