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DIN EN ISO 10651-2:2011-06

DIN EN ISO 10651-2:2011-06

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS

Available format(s)

Hardcopy , PDF

Superseded date

01-04-2016

Superseded by

DIN EN ISO 80601-2-72:2016-04

Language(s)

German

Published date

01-01-2011

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Hardcopy - German
PDF - German

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Allgemeine Anforderungen und Allgemeines
    über 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 Bereiche und grundlegende Anforderungen
38 Aufschriften, Begleitpapiere
39 Gemeinsame Anforderungen an Geräte der
    Klassen AP und APG
40 Anforderungen und Prüfungen für Geräte der
    Klasse AP, ihre Geräteteile und Bauteile
41 Anforderungen und Prüfungen für Geräte der
    Klasse APG, ihre Geräteteile und Bauteile
42 Übermässige Temperaturen
43 Brandverhütung
44 Überlaufen, Verschütten, Auslaufen, Feuchte,
    Eindringen von Flüssigkeiten, Reinigung,
    Sterilisation, Desinfektion und Verträglichkeit
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
101 Alarmsysteme
102 Anhänge von IEC 60601-1:1998
Anhang AA (informativ) Begründungen
Anhang BB (informativ) Verweisung auf die
          grundlegenden Anforderungen
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
          Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG

Describes requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support.

DevelopmentNote
Supersedes DIN EN 794-2. (10/2004) A transition period, as set out in DIN EN ISO 80601-2-72 issue 04-2016 exists until 30-09-2018. (05/2016)
DocumentType
Standard
Pages
46
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

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EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
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ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
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IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
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
ISO 5359:2014 Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases
ISO 5362:2006 Anaesthetic reservoir bags
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/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 10524-3:2005 Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves
ISO 8835-5:2004 Inhalational anaesthesia systems Part 5: Anaesthetic ventilators
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
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ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
VDE 0750-1-1 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY; 1 COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
ISO 14971:2007 Medical devices Application of risk management to medical devices
VDE 0750-1-4 : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY; COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
EN 13014:2000/AC:2002 CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers
VDE 0750-1 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
DIN EN ISO 4135:2002-03 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001); Trilingual version EN ISO 4135:2001
ISO 10524-2:2005 Pressure regulators for use with medical gases Part 2: Manifold and line pressure regulators
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