EN 13544-1:2007
(Main)Respiratory therapy equipment - Part 1: Nebulizing systems and their components
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 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).
Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile
Der in EN 60601 1:1990, Abschnitt 1, 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 Atemsystem Medikamente in Aerosolform an Menschen abzugeben.
Diese Europäische Norm schließt gasbetriebene Vernebler, die z. B. mit Kompressoren, Rohrleitungs¬systemen, Gasflaschen usw. betrieben werden, oder elektrische Vernebler (z. B. Ultraschall- und Membrangeräte) oder von Hand betriebene Vernebler ein.
ANMERKUNG Anforderungen an Vernebler mit gleichzeitiger Anfeuchtungsfunktion sind in EN ISO 8185:1997 + AC:2002 Anfeuchter (siehe 56.102) festgelegt.
Diese Europäische Norm schließt keine Vernebler ein, die bereits mit einem speziellen Arzneimittel vorgefüllt sind (z. B. MDI, DPI).
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 l’administration de 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 (par exemple dispositifs à ultrasons et membrane) ou les nébuliseurs manuels.
NOTE Les exigences relatives aux nébuliseurs également utilisés comme humidificateurs sont spécifiées dans l’EN ISO 8185:1997 + AC: 2002 « Humidificateurs » (voir 56.102).
La présente Norme européenne ne s’applique pas aux nébuliseurs préchargés avec un produit pharmaceutique spécifique (par exemple MDI, DPI).
Dihalna oprema za zdravljenje - 1. del: Razprševalni sistemi in njihovi sestavni deli
General Information
- Status
- Withdrawn
- Publication Date
- 24-Apr-2007
- Withdrawal Date
- 18-Aug-2009
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 19-Aug-2009
- Completion Date
- 19-Aug-2009
Relations
- Effective Date
- 22-Dec-2008
- Replaces
EN 13544-1:2001 - Respiratory therapy equipment - Part 1: Nebulizing systems and their components - Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 19-Jan-2023
- Effective Date
- 22-Dec-2008
Frequently Asked Questions
EN 13544-1:2007 is a standard published by the European Committee for Standardization (CEN). Its full title is "Respiratory therapy equipment - Part 1: Nebulizing systems and their components". This standard covers: 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).
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).
EN 13544-1:2007 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13544-1:2007 has the following relationships with other standards: It is inter standard links to EN 13544-1:2001/A1:2004, EN 13544-1:2001, EN 13544-1:2001/AC:2004, EN 13544-1:2007+A1:2009, EN 13544-1:2007/prA1. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13544-1:2007 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/295. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 13544-1:2007 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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 13544-1:2007SIST EN 13544-1:2007en,fr,de11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:SIST EN 13544-1:2002/AC:2005SIST EN 13544-1:2002/A1:2005SIST EN 13544-1:20021DGRPHãþDSLOVENSKI
STANDARDSIST EN 13544-1:200701-oktober-2007
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13544-1April 2007ICS 11.040.10Supersedes EN 13544-1:2001
English VersionRespiratory therapy equipment - Part 1: Nebulizing systems andtheir componentsMatériel respiratoire thérapeutique - Partie 1: Systèmes denébulisation et leurs composantsAtemtherapiegeräte - Teil 1: Verneblersysteme und derenBauteileThis European Standard was approved by CEN on 22 March 2007.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 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13544-1:2007: E
Rationale.24 Annex B B (informative)
Diameters of the particles depositable fraction.27 Annex C C (normative)
Test methods for the aerosol output rate, the aerosol output and for particle sizing.28 CC.1 Method of test for the aerosol output rate.28 CC.1.1 Test conditions.28 CC.1.2 R) Principle of test.28 CC.1.3 Test equipment.28
Mass balance checks on cascade impactor tests.36 DD.1 Aerosol output rate and aerosol output tests:.36 DD.2 Particle sizing test.36 Annex E E (informative)
Environmental aspects.37 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices.39 Bibliography.41
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.
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, Graphical symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with 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.
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 14971:2000) 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) IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition temperature
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. 4.2 Clause 4 of EN 60601-1:1990 Clause 4 of EN 60601-1:1990 applies.
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. 31 Microwave radiation Clause 31 of EN 60601-1:1990 applies. 32 Light radiation (including lasers) Clause 32 of EN 60601-1:1990 applies. 33 Infra-red radiation Clause 33 of EN 60601-1:1990 applies. 34 Ultra-violet radiation Clause 34 of EN 60601-1:1990 applies. 35 Acoustical energy (including ultra-sonics) Clause 35 of EN 60601-1:1990 applies.
EN 1281-2 unless they comply with the engagement, disengagement and leakage requirements of
EN ISO 5356-1 or EN 1281-2. bb) flow-direction-sensitive component connectors
EN ISO 7396-1 a pressure regulator complying with EN ISO 10524-1 or EN ISO 10524-3, the inlet connector shall be either the body of a Non-Interchangeable-Screw-Threaded (NIST) connector complying with EN 739 or a
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