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
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.
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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

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
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

1) Will be superseded by EN ISO 5356-2, which is currently under preparation. SIST EN 13544-1:2007+A1:2009

(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

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

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 following addition: aa) units  gas supply pressures shall be displayed in kPa. NOTE 1 Additional units e.g. bar can be used.  pressures in breathing systems shall be displayed in Pa times 100. NOTE 2 Additional units e.g. cm H2O can be used.  flows shall be displayed in l/min. 6.4 Symbols EN 980 and 6.4 of EN 60601-1:1990 apply. 6.8.2 Instructions for use In 6.8.2 add the following items: aa) as far as applicable the following information shall be provided with the nebulizing system, its parts or the packages thereof, and EN 1041 shall apply; SIST EN 13544-1:2007+A1:2009

EN ISO 3744. The A-weighted background level of extraneous noise shall be at least 10 dB below that measured during the test. 27 Pneumatic and hydraulic power Clause 27 of EN 60601-1:1990 applies. 28 Suspended masses Clause 28 of EN 60601-1:1990 applies. Section five - Protection against hazards from unwanted or excessive radiation 29 X-radiation Clause 29 of EN 60601-1:1990 applies. 30 Alpha, beta, gamma, neutron radiation and other particle radiation Clause 30 of EN 60601-1:1990 applies. SIST EN 13544-1:2007+A1:2009

Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction. See also
6.8.2 ii)." 49 Interruption of the power supply Clause 49 of EN 60601-1:1990 applies. Section eight - Accuracy of operating data and protection against hazardous output 50 Accuracy of operating data Clause 50 of EN 60601-1:1990 applies with the following addition: 50.101 While the equipment is in normal use as described by the manufacturer, all displays of measured values shall be accurate within the manufacturer’s disclosed range when tested under the operating conditions given in 10.2.2 of EN 60601-1:1990 and 10.101 of this European Standard. 50.102 Compressor operating data If relevant and while the compressor is in normal use as described by the manufacturer (see 6.8.2 aa) 10th dash), all operating data shall be accurate within the manufacturer’s disclosed range when tested under the manufacturer’s conditions. SIST EN 13544-1:2007+A1:2009
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