DIN EN 13544-1:2009-12
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
Hardcopy , PDF
07-03-2021
English
01-01-2009
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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 |
| Standards | Relationship |
| NS EN 13544-1 : 2007 + A1 2009 | Identical |
| UNI EN 13544-1 : 2009 | Identical |
| NBN EN 13544-1 : 2007 + A1 2009 | Identical |
| BS EN 13544-1 : 2007 | Identical |
| I.S. EN 13544-1:2007 | Identical |
| UNE-EN 13544-1:2007 | Identical |
| EN 13544-1:2007+A1:2009 | Identical |
| SN EN 13544-1 : 2007 + A1 2010 | Identical |
| NF EN 13544-1 : 2007 + A1 2009 | Identical |
| NEN EN 13544-1 : 2007 + A1 2009 | Identical |
| 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 737-6:2003 | 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 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 4135:2001) |
| 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 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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