SIST EN 13544-1:2007+A1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dihalna oprema za zdravljenje - 1. del: Razprševalni sistemi in njihovi sestavni deliAtemtherapiegeräte - Teil 1: Verneblersysteme und deren BauteileMatériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composantsRespiratory therapy equipment - Part 1: Nebulizing systems and their components11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 13544-1:2007+A1:2009SIST EN 13544-1:2007+A1:2009en,fr,de01-oktober-2009SIST EN 13544-1:2007+A1:2009SLOVENSKI
STANDARD



SIST EN 13544-1:2007+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13544-1:2007+A1
August 2009 ICS 11.040.10 Supersedes EN 13544-1:2007English Version
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
Matériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composants
Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile This European Standard was approved by CEN on 22 March 2007 and includes Amendment 1 approved by CEN on 23 July 2009.
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, 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 © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-1:2007+A1:2009: ESIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 2 Contents Page Foreword .5Introduction .61R) Scope .72Normative references .73Terms and definitions .94General requirements and general requirements for test . 104.1Modifications to Clause 3 of EN 60601-1:1990 . 104.2Clause 4 of EN 60601-1:1990 . 114.3Alternative type-test methods . 115Classification . 116Identification, marking and documents . 116.1Marking on the outside of equipment or equipment parts . 116.3Marking of controls and instruments . 126.4Symbols . 126.8.2Instructions for use . 126.8.3Technical description . 147Power input . 158Basic safety categories . 159Removable protective means . 1510Environmental conditions . 1511Not used . 1512Not used . 1513General . 1514Requirements related to classification . 1515Limitation of voltage and/or energy . 1616Enclosures and protective covers . 1617Separation . 1618Protective earthing, functional earthing and potential equalization . 1619Continuous leakage currents and patient auxiliary currents . 1620Dielectric strength . 1621Mechanical strength . 1622Moving parts . 1623Surfaces, corners and edges . 1624Stability in normal use . 1725Expelled parts . 1726Vibration and noise. 1727Pneumatic and hydraulic power . 17SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 3 28Suspended masses . 1729X-radiation . 1730Alpha, beta, gamma, neutron radiation and other particle radiation . 1731Microwave radiation . 1832Light radiation (including lasers) . 1833Infra-red radiation . 1834Ultra-violet radiation . 1835Acoustical energy (including ultra-sonics) . 1836Electromagnetic compatibility . 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 . 1941R) Requirements and tests for Category APG equipment, parts and components thereof . 1942Excessive temperatures . 1943R) Fire prevention . 1944Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection . 1945Pressure vessels and parts subject to pressure . 2046Human errors . 2047Electrostatic charges . 2048Biocompatibility . 2049Interruption of the power supply . 2050Accuracy of operating data . 2051Protection against hazardous output . 2152Abnormal operation and fault conditions . 2153Environmental tests . 2154General . 2155Enclosures and covers . 2256Components and general assembly . 2257Mains parts, components and layout . 2358Protective earthing - Terminals and connections . 2359Construction and layout . 23Annex A A (informative)
Rationale . 24Annex B B (informative)
Diameters of the particles depositable fraction . 27Annex C C (normative)
Test methods for the aerosol output rate, the aerosol output and for particle sizing . 28CC.1Method of test for the aerosol output rate . 28CC.1.1Test conditions . 28CC.1.2R) Principle of test . 28CC.1.3Test equipment . 28SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 4 Annex D D (normative)
Mass balance checks on cascade impactor tests . 36DD.1Aerosol output rate and aerosol output tests: . 36DD.2Particle sizing test . 36Annex E E (informative)
Environmental aspects . 37Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 39Bibliography . 43
SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 5 Foreword This document (EN 13544-1:2007+A1:2009) 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 February 2010 and conflicting national standards shall be withdrawn at the latest by March 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 includes Amendment 1, approved by CEN on 2009-07-23. This document supersedes !EN 13544-1:2001". The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ". 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. This European Standard applies to respiratory therapy equipment and has been prepared in three parts. This Part addresses nebulizing systems; Parts 2 and 3 address respectively tubing and connectors, and air entrainment devices. 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, 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.
SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 6 Introduction This European Standard is based on EN 60601-1:1990. In EN 60601-1:1990, this type of European Standard is referred to as a “Particular Standard”. As stated in 1.3 of EN 60601-1:1990 the requirements of this European Standard take precedence over those of
EN 60601-1:1990. Clauses, subclauses, tables and figures additional to those in EN 60601-1:1990 are numbered beginning 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 European Standard are given in Annex AA. Such requirements are indicated by the letter 'R' after the clause number. SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 7 Section one – General 1 R) Scope 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 and membrane devices) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC: 2002 “Humidifiers” (see 56.102). This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI). 2 Normative references The following referenced documents are 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 556 (all parts), Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” EN 737-1, Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum ENV 737-6, Medical gas pipeline systems — Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum EN 739, Low pressure hose assemblies for use with medical gases EN 980, !Symbols" for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer !of" medical devices EN 1281-21), Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock fittings EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements (ISO 594-1:1986) EN 60601-1:1990, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:1988)
1) Will be superseded by EN ISO 5356-2, which is currently under preparation. SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 8 EN 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral Standard: Electromagnetic compatibility — Requirements and tests !(IEC 60601-1-2:2007, modified)" !EN 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential performance — Collateral Standard: Usability (IEC 60601-1-6:2006)" EN 61000-4-2:1995, Electromagnetic compatibility (EMC) — Part 4: Testing and measurement techniques — Section 2: Electrostatic discharge immunity test — Basic EMC publication (IEC 61000-4-2:1995) EN 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications (IEC 61672-1:2002) EN 61672-2, Electroacoustics — Sound level meters — Part 2: Pattern evaluation tests (IEC 61672-2:2003) !EN 62304, Medical device software — Software life-cycle processes (IEC 62304:2006) EN 62366, Medical devices — Application of usability engineering to medical devices
(IEC 62366:2007)" EN ISO 3744, Acoustics — Determination of sound power levels of noise sources using sound pressure — Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994) EN ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary (ISO 4135:2001) EN ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO 5356-1:2004) EN ISO 7396-1, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and vacuum !(ISO 7396-1:2007)" EN ISO 8185, Humidifiers for medical use — General requirements for humidification systems !(ISO 8185:2007)" EN ISO 10524-1, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) EN ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) EN ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) EN ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose (ISO 11137-2:2006) EN ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) EN ISO 14971, Medical devices — Application of risk management to medical devices
!(ISO 14971:2007)" EN ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen (ISO 15001:2003) EN ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 9 IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition temperature 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 4135:2001, 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. 3.1 aerosol suspension of particles in gas NOTE Particles can be liquid or solid. 3.2 aerosol output amount of aerosol delivered by the nebulizing system for given filled volume 3.3 aerosol output rate amount of aerosol delivered by the nebulizing system per unit of time 3.4 anatomical airways natural pathways through which respired gases pass in either direction between the atmosphere and the alveoli (see Annex BB) 3.5 manually-powered nebulizer nebulizer which operates by means of human power 3.6 electrically-powered nebulizer nebulizer which operates by means of electrical power 3.7 gas-powered nebulizer (jet nebulizer) nebulizer in which aerosol is generated by compressed gas 3.8 ultrasonic nebulizer nebulizer in which aerosol is generated by means of ultrasound 3.9 liquid container part of the nebulizer which contains the liquid for nebulization 3.10 maximum fill volume maximum volume of liquid, expressed in millilitres, in the liquid container during normal operation when the nebulizer is filled to its maximum filling level SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 10 3.11 nebulizer device which converts a liquid into an aerosol 3.12 nebulizing system device, including all parts, required to convert a liquid into an aerosol and make it available for inhalation 3.13 validation confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled NOTE 1 The term "validated" is used to designate the corresponding status. NOTE 2 The use conditions for validation can be real or simulated.
4 General requirements and general requirements for test 4.1 Modifications to Clause 3 of EN 60601-1:1990 Clause 3 of EN 60601-1:1990 applies with the following modifications. Replace 3.1 with the following: Nebulizing systems and nebulizers shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could reasonably be foreseen using risk management procedures in accordance with EN ISO 14971 and which is connected with their intended application, in normal condition and in single fault condition. 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. NOTE See also 54.101. bb) R)
A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous situations may remain undetected over a period of time and as a consequence may lead to an unacceptable risk. In that case subsequent fault conditions need to be considered as a single fault condition. Specific risk control measures need to be determined within the risk management process to deal with such situations. SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 11 !In 3.10 Clinical evaluation add the following: A clinical evaluation shall be performed and documented in the risk management file. Check compliance by inspection of the risk management file." 4.2 Clause 4 of EN 60601-1:1990 Clause 4 of EN 60601-1:1990 applies. 4.3 Alternative type-test methods The manufacturer may use type-test methods for particle sizing, different from those specified in Annex CC. Validation of alternative type-test methods shall be performed against the reference method in Annex CC to demonstrate that an equivalent particle size distribution curve and derived results are obtained. Demonstration shall be circulated in the technical documentation of the manufacturer. Evidence shall be provided upon request e.g. to Regulatory Authorities. 5 Classification Clause 5 of EN 60601-1:1990 applies. NOTE A nebulizing system can have applied parts of different types. 6 Identification, marking and documents Clause 6 of EN 60601-1:1990 applies with the following additions and modifications. 6.1 Marking on the outside of equipment or equipment parts In 6.1 add the following to item e): !The name or trademark and address of the manufacturer. For devices imported into the European Union the following applies: the name and address of the person responsible and of the authorised representative of the manufacturer established within the European Community shall be 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 or mouth piece one-way valve) shall be either clearly and durably marked with an arrow showing direction of gas flow if operator-detachable, or shall be permanently attached (see note of 6.8.2 dd)); 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 of sterilization; SIST EN 13544-1:2007+A1:2009



EN 13544-1:2007+A1:2009 (E) 12  if appropriate, the batch code, preceded by the symbol LOT in accordance with EN 980, or serial 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 !. For single use devices the manufacturer shall disclose the risks associated with reusing in the instructions for use or upon request"; !NOTE 1 Manufacturers' attention is drawn to the regulatory provision requiring that the indication of single use must be consistent across the Community."  any special storage and/or handling conditions;  any warning and/or precaution to take e.g. compatibility with the use of oxygen and oxygen mixtures, and compatibility between oxygen and administrated drugs;  for active medical devices the year of manufacture except for those covered by 6.1 cc) 5th dash); !NOTE 2"
This 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 both sterile and non-sterile placed on the market by the same manufacturer;  if appropriate, packages containing parts made of antistatic or conductive material shall be clearly marked with the word “ANTISTATIC” or “CONDUCTIVE”;  the liquid container of the nebulizer shall be marked at the maximum filling level. This shall be defined in the instruction for use (see 6.8.2 aa) 9th dash). 6.3 Marking of controls and instruments 6.3 of EN 60601-1:1990 applies with the f
...