Respiratory therapy equipment - Part 1: Nebulizing systems and their components

The scope given in clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following:
1.1 This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system.
This European Standard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic) or manually-powered nebulizers.
NOTE   Requirements for nebulizers having also a humidification function are specified in EN ISO 8185 "Humidifiers".
This European Standard does not include nebulizers precharged with a specific medicinal product and not for universal application.

Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile

Der in Abschnitt 1 von EN 60601-1:1990 angegebene Anwendungsbereich gilt mit der Ausnahme, dass 1.1 durch Folgendes zu ersetzen ist:
1.1 Diese Europäische Norm legt Anforderungen an Verneblersysteme fest, die dazu verwendet werden, über das Beatmungssystem Medikamente in Aerosolform an Menschen abzugeben.
Diese Europäische Norm umfasst gasbetriebene Vernebler, die z. B. mit Kompressoren, Rohrleitungssystemen, Gasflaschen usw. betrieben werden, sowie elektrisch betriebene Vernebler (z. B. mit Ultraschall) oder von Hand betriebene Vernebler.
ANMERKUNG   Anforderungen an Vernebler mit gleichzeitiger Anfeuchtungsfunktion sind in EN ISO 8185 ¿Anfeuchter für medizinische Zwecke - Allgemeine Anforderungen an Anfeuchtungssysteme" festgelegt.
Diese Europäische Norm umfasst keine Vernebler, die bereits mit einem speziellen Arzneimittel vorgefüllt sind, und keine Vernebler, die zur allgemeinen Anwendung bestimmt sind.
.

Matériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composants

Le domaine d'application de l'article 1 de l'EN 60601-1:1990 s'applique, à l'exception du 1.1 qui est remplacé par le texte suivant :
1.1   La présente Norme européenne spécifie les exigences relatives aux systèmes de nébulisation utilisés pour la délivrance des médicaments aux personnes sous forme d'un aérosol via le système respiratoire.
Elle inclut les nébuliseurs à énergie pneumatique alimentés par compresseurs, par réseau de gaz médicaux, bouteilles, etc., à énergie électrique ( ultrasonique, par exemple) ou les nébuliseurs manuels.
NOTE   Les exigences relatives aux nébuliseurs également utilisés comme humidificateurs sont spécifiées dans l'EN ISO 8185 « Humidificateurs ».
La présente Norme européenne ne traite pas des nébuliseurs préremplis avec un médicament spécifique et non destinés à des applications universelles.

Dihalna oprema za zdravljenje – 1. del: Razprševalni sistemi in njihovi sestavni deli

General Information

Status
Withdrawn
Publication Date
28-Aug-2001
Withdrawal Date
24-Apr-2007
Current Stage
9960 - Withdrawal effective - Withdrawal
Due Date
25-Apr-2007
Completion Date
25-Apr-2007

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Respiratory therapy equipment - Part 1: Nebulizing systems and their componentsDihalna oprema za zdravljenje – 1. del: Razprševalni sistemi in njihovi sestavni deliMatériel respiratoire thérapeutique - Partie 1: Systemes de nébulisation et leurs composantsAtemtherapiegeräte - Teil 1: Verneblersysteme und deren BauteileTa slovenski standard je istoveten z:EN 13544-1:2001SIST EN 13544-1:2002en11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:SLOVENSKI

STANDARDSIST EN 13544-1:200201-maj-2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13544-1August 2001ICS 11.040.10English versionRespiratory therapy equipment - Part 1: Nebulizing systems andtheir componentsAtemtherapiegeräte - Teil 1: Verneblersysteme und derenBauteileThis European Standard was approved by CEN on 29 June 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36

B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13544-1:2001 E

EN 13544-1:2001 (E)2ContentspageForeword.......................................................................................................................................................................5Introduction...................................................................................................................................................................6Section one - General...................................................................................................................................................71R) Scope..........................................................................................................................................................72Normative references.......................................................................................................................................73Terms and definitions.......................................................................................................................................84General requirements and general requirements for test................................................................................95Classification..................................................................................................................................................106Identification, marking and documents..........................................................................................................107Power input....................................................................................................................................................13Section two - Environmental conditions......................................................................................................................148Basic safety categories..................................................................................................................................149Removable protective means........................................................................................................................1410Environmental conditions...............................................................................................................................1411Not used........................................................................................................................................................1412Not used........................................................................................................................................................14Section three - Protection against electric shock hazards..........................................................................................1513General..........................................................................................................................................................1514Requirements related to classification...........................................................................................................1515Limitation of voltage and/or energy................................................................................................................1516Enclosures and protective covers..................................................................................................................1517Separation......................................................................................................................................................1518Protective earthing, functional earthing and potential equalization...............................................................1519R) Continuous leakage currents and patient auxiliary currents.....................................................................1520Dielectric strength..........................................................................................................................................15Section four - Protection against mechanical hazards...............................................................................................1621Mechanical strength.......................................................................................................................................1622Moving parts..................................................................................................................................................1623Surfaces, corners and edges.........................................................................................................................1624Stability in normal use....................................................................................................................................1625Expelled parts................................................................................................................................................1626Vibration and noise........................................................................................................................................1627Pneumatic and hydraulic power.....................................................................................................................1628Suspended masses.......................................................................................................................................16Section five - Protection against hazards from unwanted or excessive radiation......................................................17

EN 13544-1:2001 (E)329X-radiation.....................................................................................................................................................1730Alpha, beta, gamma, neutron radiation and other particle radiation.............................................................1731Microwave radiation.......................................................................................................................................1732Light radiation (including lasers)....................................................................................................................1733Infra-red radiation..........................................................................................................................................1734Ultra-violet radiation.......................................................................................................................................1735Acoustical energy (including ultra-sonics).....................................................................................................1736Electromagnetic compatibility........................................................................................................................17Section six - Protection against hazards of ignition of flammable anaesthetic mixtures............................................1837R) Locations and basic requirements............................................................................................................1838R) Marking, accompanying documents.........................................................................................................1839R) Common requirements for category AP and category APG equipment...................................................1840R) Requirements and tests for Category AP equipment, parts and components thereof.............................1841R) Requirements and tests for Category APG equipment, parts and components thereof..........................18Section seven - Protection against excessive temperatures and other safety hazards.............................................1942Excessive temperatures................................................................................................................................1943R) Fire prevention..........................................................................................................................................1944Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection.................1945Pressure vessels and parts subject to pressure............................................................................................1946Human errors.................................................................................................................................................2047Electrostatic charges.....................................................................................................................................2048Biocompatibility..............................................................................................................................................2049Interruption of the power supply....................................................................................................................20Section eight - Accuracy of operating data and protection against hazardous output...............................................2150Accuracy of operating data............................................................................................................................2151Protection against hazardous output.............................................................................................................21Section nine - Abnormal operation and fault conditions; environmental tests............................................................2252Abnormal operation and fault conditions.......................................................................................................2253Environmental tests.......................................................................................................................................22Section ten - Constructional requirements.................................................................................................................2354R) General.....................................................................................................................................................2355Enclosures and covers..................................................................................................................................2356Components and general assembly..............................................................................................................2357Mains parts, components and layout.............................................................................................................2458Protective earthing - Terminals and connections..........................................................................................2459Construction and layout.................................................................................................................................24Annex A A (informative)

Rationale...........................................................................................................................26Annex B B (informative)

Diameters of the particles depositable fraction................................................................29Annex C C (normative)

Test methods for the aerosol output rate, the aerosol output and for particlesizing..............................................................................................................................................................30Annex D D (informative)

Method for characterisation of nebulizers with respect to droplet size usinglaser diffraction)..............................................................................................................................................39

EN 13544-1:2001 (E)4Annex E E (informative)

Mass balance checks on cascade impactor tests............................................................44Annex ZA (informative)

Clauses of this European Standard addressing Essential Requirements orother provisions of EU Directives...................................................................................................................45Bibliography................................................................................................................................................................48

EN 13544-1:2001 (E)5ForewordThis European Standard has been prepared by Technical Committee CEN/TC 215 "Respiratory andanaesthetic 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 anidentical text or by endorsement, at the latest by February 2002, and conflicting national standardsshall be withdrawn at the latest by February 2002.This European Standard has been prepared under a mandate given to CEN by the EuropeanCommission and the European Free Trade Association, and supports essential requirements of EUDirective(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of thisstandard.This European Standard applies to respiratory therapy equipment and has been prepared in threeparts. This Part addresses nebulizing systems; Parts 2 and 3 address respectively tubing andconnectors, and air entrainment devices.Annex CC is normative and forms part of this European Standard. Annexes AA, BB, DD, EE and ZAare for information only.According to the CEN/CENELEC Internal Regulations, the national standards organizations of thefollowing countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

EN 13544-1:2001 (E)6IntroductionThis European Standard is based on European Standard EN 60601-1:1990.In EN 60601-1:1990, this type of European Standard is referred to as a “Particular Standard”. Asstated in 1.3 of EN 60601-1:1990, the requirements of this European Standard take precedenceover those of EN 60601-1:1990.Clauses, subclauses, tables and figures additional to those in EN 60601-1:1990 are numberedbeginning at '101'. Additional annexes are lettered beginning at 'AA' except for annex 'ZA'.Additional items in lettered lists are lettered beginning 'aa)'.Rationales for some of the requirements of this standard are given in annex AA. Such requirementsare indicated by the letter 'R' after the clause number.

EN 13544-1:2001 (E)7Section one - General1 R) ScopeThe scope given in clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by thefollowing:1.1 This European Standard specifies requirements for nebulizing systems used for the delivery ofdrugs in an aerosol form to humans through the respiratory system.This European Standard includes gas-powered nebulizers which may be derived from e.g.compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic) ormanually-powered nebulizers.NOTERequirements for nebulizers having also a humidification function are specified in EN ISO 8185“Humidifiers”.This European Standard does not include nebulizers precharged with a specific medicinal productand not for universal application.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text, and thepublications are listed hereafter. For dated references, subsequent amendments to or revisions ofany of these publications apply to this European Standard only when incorporated in it byamendment or revision. For undated references the latest edition of the publication referred toapplies (including amendments).Appendix L of EN 60601-1:1990 applies with the following additions :EN 550, Sterilization of medical devices - Validation and routine control of ethylene oxidesterilization.EN 552, Sterilization of medical devices - Validation and routine control of sterilization by irradiation.EN 554, Sterilization of medical devices - Validation and routine control of sterilization by moist heat.EN 556:1994+A1:1998, Sterilization of medical devices - Requirements for medical devices to belabelled “Sterile”.EN 737-3, Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases andvacuum.EN 738-1, Pressure regulators for use with medical gases - Part 1: Pressure regulators andpressure regulators with flow-metering devices.EN 980, Graphical symbols for use in the labelling of medical devices.EN 1041, Information supplied by the manufacturer with medical devices.EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones andsockets.EN 1281-2, Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threadedweight-bearing connectors (ISO 5356-2:1987 modified).

EN 13544-1:2001 (E)8EN ISO 4135:1995, Anaesthesiology - Vocabulary (ISO 4135:1995).EN ISO 8185, Humidifiers for medical use – General requirements for humidification systems (ISO8185:1997).EN 60601-1:1990, Medical electrical equipment - Part 1: General requirements for safety(IEC 60601-1:1988).EN 60601-1-2, Medical electrical equipment - Part 1: General requirements for safety - CollateralStandard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:1993).IEC 60079-4, Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignitiontemperature.IEC 60651, Sound level meters; amendment 1.IEC 61000-4-2, Electromagnetic compatibility (EMC) – Part 4: Testing and measurement techniques– Section 2: Electrostatic discharge immunity test - Basic EMC publication.ISO 3744, Acoustics - Determination of sound power levels of noise sources using sound pressure -Engineering method in an essentially free field over a reflecting plane1).European Pharmacopoeia, Monograph on preparations for inhalation (3rd edition).3 Terms and definitionsFor the purposes of this European Standard, the terms and definitions given in EN ISO 4135:1995,clause 2 of EN 60601-1:1990 and the following apply :2.1.5 R) applied part : Add the following item :All parts of the nebulizer intended to be connected to the patient or to the breathing system.3.1aerosolsuspension of particles in gasNOTEParticles can be liquid or solid.3.2aerosol outputamount of aerosol delivered by the nebulizing system for given filled volume3.3aerosol output rateamount of aerosol delivered by the nebulizing system per unit of time3.4anatomical airwaysnatural pathways through which respired gases pass in either direction between the atmosphereand the alveoli (see annex BB)

1) This reference will be replaced, when EN 31201 is published, by reference to EN 31201 “Acoustics - Noise emitted bymachinery and equipment - Measurement of emission sound pressure levels at the work station and at other specifiedpositions - Engineering method in an essentially free field over a reflecting plane (ISO/DIS 11201:1993)”.

EN 13544-1:2001 (E)93.5manually-powered nebulizernebulizer which operates by means of human power3.6electrically-powered nebulizernebulizer which operates by means of electrical power3.7gas-powered nebulizer (jet nebulizer)nebulizer in which aerosol is generated by compressed gas3.8ultrasonic nebulizernebulizer in which aerosol is generated by means of ultrasound3.9liquid containerpart of the nebulizer which contains the liquid for nebulization3.10maximum fill volumemaximum volume of liquid, expressed in millilitres, in the liquid container during normal operationwhen the nebulizer is filled to its maximum filling level3.11nebulizerdevice which converts a liquid into an aerosol3.12nebulizing systemdevice, including all parts, required to convert a liquid into an aerosol and make it available forinhalation4 General requirements and general requirements for test4.1 Modifications to clause 3 of EN 60601-1:1990Clause 3 of EN 60601-1:1990 applies with the following additions.In 3.6 add the following :aa)applicable single fault conditions are : short and open-circuits of components or wiring which can : cause sparks to occur ; or increase the energy of sparks ; or increase temperature (see section seven) ; incorrect output resulting from software error.NOTESee also 54.101.

EN 13544-1:2001 (E)10bb)R) an oxidant leak which is not detected by e.g. an alarm or periodic inspection shall beconsidered a normal condition and not a single fault condition.4.2 Clause 4 of EN 60601-1:1990Clause 4 of EN 60601-1:1990 applies.5 ClassificationClause 5 of EN 60601-1:1990 applies.NOTEA nebulizing system can have applied parts of different types.6 Identification, marking and documentsClause 6 of EN 60601-1:1990 applies with the following additions and modifications.6.1 Marking on the outside of equipment or equipment partsIn 6.1 add the following to item e) :The name or trademark and address of the manufacturer. For devices imported into the EuropeanUnion the following applies: the name and address of the person responsible or of the authorisedrepresentative of the manufacturer or the importer established within the European Community shallbe provided with the device or with the accompanying document.In 6.1 add the following additional items :aa)all flow-direction sensitive components, breathing attachments or parts (e.g. face mask ormouth piece one-way valve etc.) shall be either clearly and durably marked with an arrow showingdirection of gas flow if operator-detachable, or shall be permanently attached (see note of 6.8.2dd)) ;bb)if gas-specific, the inlet and outlet shall be identified by clear and durable marking ;cc)marking of devices, labels and packaging.Devices, labels and/or packaging shall contain the following : device identification and content information ; if appropriate, the symbol STERILE in accordance with EN 980 together with the method ofsterilization ; if appropriate, the batch code, preceded by the symbol LOT in accordance with EN 980, orserial number ; the expiry date, if the device is sensitive to storage or shelf life in accordance with EN 980 ; if appropriate, an indication that the device is for single use ; any special storage and/or handling conditions ; any warning and/or precaution to take ;

EN 13544-1:2001 (E)11 for active medical devices the year of manufacture except for those covered by 6.1 cc) 5thdash) ;NOTEThis indication can be the batch or serial number. if appropriate, the recommended method(s) of cleaning, disinfection and sterilization ; device packaging and/or labelling shall differentiate between the same or similar products bothsterile and non-sterile placed on the market by the same manufacturer ; if appropriate, packages containing parts made of antistatic or conductive material shall beclearly marked with the word “ANTISTATIC” or “CONDUCTIVE” ; the liquid container of the nebulizer shall be marked at the maximum filling level. This shall bedefined in the instruction for use (see 6.8.2 aa) 9th dash).6.3Marking of controls and instruments6.3 of EN 60601-1:1990 applies with the following addition :aa)units gas supply pressures shall be displayed in kPa.NOTE 1Additional units e.g. bar can be used. pressures in breathing systems shall be displayed in Pa times 100.NOTE 2Additional units e.g. cm H2O can be used. flows shall be displayed in L/min.6.4SymbolsEN 980 and 6.4 of EN 60601-1:1990 apply.6.8.2Instructions for useIn 6.8.2 add the following items :aa)as far as applicable the following information shall be provided with the nebulizing system, itsparts or the packages thereof, and EN 1041 shall apply ; the purpose and intended use of the nebulizing system and/or its parts ; a list of the necessary parts which are not an integral part of the nebulizing system; a statement that the parts listed in 6.8.2 aa) 2nd dash are required for correct function andthat they have to be in compliance with this European Standard ; the minimum and maximum recommended driving-gas flows and the correspondingpressures for gas-powered nebulizers ;

EN 13544-1:2001 (E)12 R) - the particle size distribution curve, measured as described in annex CC, Figure CC.3,under the normal operating conditions for maximum and minimum, if applicable, pressuresand flows ; the aerosol output and aerosol output rate at the manufacturer’s stated minimum andmaximum driving-gas flows and corresponding pressures in the testing conditions defined inannex CC ; whether the nebulizer is suitable for use in anaesthetic breathing systems or lung ventilatorbreathing systems ; the maximum temperature, if above ambient, reached in the nebulizing chamber for themaximum recommended fill volume of the solution in normal use conditions ; the maximum and minimum recommended fill volume as declared by the manufacturer ; details of recommended power or control devices and accessories for use with thenebulizer ; the maximum A-weighted sound pressure level as measured in clause 26 ; a statement that performance information provided by the manufacturer in accordance withthis standard may not apply to drugs supplied in suspension or high viscosity form. In suchcases, information should be sought from the drug supplier ; the recommended driving gases ;bb)as far as applicable the following information shall be provided with the power and/or controldevice, its parts or the packages thereof : the recommended range of gas flows and the corresponding pressures ; the recommended gas(es) or gas mixture (s) ; details of recommended nebulizers and accessories for use with the power or controldevice ;cc)the instructions for use shall contain information on methods of cleaning and/or sterilization priorto use and the number of cycles of cleanings and/or sterilizations the nebulizing system willwithstand. These instructions shall contain procedures for reassembly (see 6.8.2 dd) ;dd)dismantling and reassemblyThe manufacturer shall recommend a functional test of operation to be carried out after reassemblyand before use.NOTEA nebulizing system intended to be dismantled by the user, e.g. for cleaning/sterilization, should bedesigned so as to minimize the risk of incorrect reassembly when all parts are mated.ee)information about monitoring, alarm and protection modulesAs far as applicable the instructions for use shall contain : a description of the methods of verifying alarm functions ; details of any pressure relief valves fitted.

EN 13544-1:2001 (E)13ff)information about electromagnetic compatibilityIf applicable the instructions for use shall include a warning statement to the effect that thefunctioning of this nebulizer may be adversely affected by electromagnetic interference exceedingthe levels specified in EN 60601-1-2 ;gg)information about disposalThe instructions for use shall include information about any precautions to be taken if there is aspecific unusual risk associated with the disposal of a device.6.8.3Technical description6.8.3 of EN 60601-1:1990 applies with the following addition :In 6.8.3a) add the following :The technical description shall additionally include the following information : interdependence of controls, if applicable ; the pressure and flow characteristics of any gas power outlet under worst case conditionsstated by the manufacturer ; the specified range of flows required from any gas source, if applicable ; if relevant, a statement of the composition and dryness specification for all gases to be suppliedto the nebulizer ; details of non-return valves and pressure relief valves and their characteristics if fitted ; lifetime of the reusable parts.7 Power inputClause 7 of EN 60601-1:1990 applies.

EN 13544-1:2001 (E)14Section two - Environmental conditions8 Basic safety categoriesClause 8 of EN 60601-1:1990 applies.9 Removable protective meansNot used.10 Environmental conditionsClause 10 of EN 60601-1:1990 applies with the following addition :10.101If it is declared by the manufacturer that a nebulizer is intended to be directly connected to apipeline

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