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DIN EN 13544-1:2009-12

DIN EN 13544-1:2009-12

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS

Available format(s)

Hardcopy , PDF

Superseded date

03-07-2021

Language(s)

English

Published date

01-01-2009

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
Einleitung
1 R) Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeine Anforderungen und allgemeine
   Anforderungen an die Prüfungen
5 Klassifikation
6 Bezeichnungen, Aufschriften und Begleitpapiere
7 Strom- bzw. Leistungsaufnahme
8 Grundlegende Sicherheitsanforderungen
9 Abnehmbare Schutzvorrichtungen
10 Umweltbedingungen
11 Nicht benutzt
12 Nicht benutzt
13 Allgemeines
14 Anforderungen in Bezug auf die Einteilung
   der Geräte
15 Begrenzung von Spannung und/oder Energie
16 Gehäuse und Schutzabdeckungen
17 Trennung
18 Schutzleiteranschluss, Betriebserdung und
   Potenzialausgleich
19 Dauer-Ableit- und Patientenhilfsströme
20 Spannungsfestigkeit
21 Mechanische Festigkeit
22 Bewegte Teile
23 Oberflächen, Ecken und Kanten
24 Standfestigkeit bei bestimmungsgemässem
   Gebrauch
25 Herausgeschleuderte Teile
26 Erschütterungen und Geräusche
27 Pneumatische und hydraulische Energie
28 Aufgehängte Massen
29 Röntgenstrahlung
30 Alpha-, Beta-, Gamma- und Neutronenstrahlung
   sowie sonstige Korpuskularstrahlung
31 Mikrowellenstrahlung
32 Lichtstrahlung (einschliesslich Laserstrahlen)
33 Infrarotstrahlung
34 Ultraviolett-Strahlung
35 Schallenergie (einschliesslich Ultraschall)
36 Elektromagnetische Verträglichkeit
37 R) Bereiche und grundlegende Anforderungen
38 R) Aufschriften, Begleitpapiere
39 R) Gemeinsame Anforderungen an Geräte der
   Klassen AP und APG
40 R) Anforderungen und Prüfungen für Geräte
   der Klasse AP, ihre Geräteteile und Bauteile
41 R) Anforderungen und Prüfungen für Geräte der
   Klasse APG, ihre Geräteteile und Bauteile
42 Übermässige Temperaturen
43 R) Brandverhütung
44 Überlaufen, Verschütten, Auslaufen, Feuchte,
   Eindringen von Flüssigkeiten, Reinigung, Sterilisation
   und Desinfektion
45 Druckbehälter und durch Druck beanspruchte Teile
46 Menschliches Versagen
47 Elektrostatische Aufladungen
48 Bioverträglichkeit
49 Unterbrechung der Stromversorgung
50 Genauigkeit der Betriebsdaten
51 Schutz gegen gefährdende Ausgangswerte
52 Nichtbestimmungsgemässer Betrieb und Fehlerfälle.
53 Umweltprüfungen
54 Allgemeines
55 Gehäuse und Abdeckungen
56 Bauteile und Allgemeines zum Zusammenbau
57 Netzteile, Bauteile und Ausführung
58 Schutzleiter - Klemmen und Verbindungen
59 Aufbau und Anordnung
Anhang AA (informativ) Begründungen
Anhang BB (informativ) Durchmesser des ablagerbaren
          Anteils der Partikel
Anhang CC (normativ) Prüfverfahren für die Rate der
          Aerosolabgabe, die Aerosolabgabe und die
          Partikelgrösse
Anhang DD (normativ) Überprüfungen der Massenbilanz
          bei Prüfungen mit Kaskaden-Aufprallsammlern
Anhang EE (informativ) Umweltgesichtspunkte
Anhang ZA (informativ) Zusammenhang zwischen dieser
          Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG
          über Medizinprodukte
Literaturhinweise

Describes requirement for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system.

DocumentType
Standard
Pages
47
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
ENV 737-6 : DRAFT 2003 MEDICAL GAS PIPELINE SYSTEMS - PART 6: DIMENSIONS AND ALLOCATION OF PROBES FOR TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
ISO 9276-1:1998 Representation of results of particle size analysis — Part 1: Graphical representation
DIN ISO 9276-1:2004-09 Representation of results of particle size analysis - Part 1: Graphical representation (ISO 9276-1:1998)
EN ISO 10524-3:2006/A1:2013 PRESSURE REGULATORS FOR USE WITH MEDICAL GASES - PART 3: PRESSURE REGULATORS INTEGRATED WITH CYLINDER VALVES (ISO 10524-3:2005/AMD 1:2013)
EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
EN 61672-2:2013/A1:2017 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 2: PATTERN EVALUATION TESTS (IEC 61672-2:2013/A1:2017)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
EN 737-1 : 1998 MEDICAL GAS PIPELINE SYSTEMS - TERMINAL UNITS FOR COMPRESSED MEDICAL GASES AND VACUUM
EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
EN 61000-4-2:2009 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
EN 1281-2 : 1995 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - SCREW-THREADED WEIGHT-BEARING CONNECTORS
EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
EN 739:1998/A1:2002 LOW-PRESSURE HOSE ASSEMBLIES FOR USE WITH MEDICAL GASES
EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
EN ISO 3744:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)
EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
EN ISO 11135-1:2007 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)
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
EN ISO 11137-1:2015 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, including Amd 1:2013)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 17665-1 : 2006 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)
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
EN ISO 4135:2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
EN 20594-1:1993/A1:1997 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
EN 980:2008 Symbols for use in the labelling of medical devices
EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
ISO 9276-2:2014 Representation of results of particle size analysis Part 2: Calculation of average particle sizes/diameters and moments from particle size distributions
ISO 17665-1:2006 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 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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PDF - English
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