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DIN EN ISO 10651-6:2011-06

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

03-07-2021

Language(s)

English

Published date

01-01-2011

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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

Defines the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required.

DevelopmentNote
Supersedes DIN EN 794-2. (10/2004)
DocumentType
Standard
Pages
42
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
DIN EN ISO 17510-1:2009-07 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures Particular requirements
ISO/IEC TR 10000-1:1998 Information technology Framework and taxonomy of International Standardized Profiles Part 1: General principles and documentation framework
ISO 10241:1992 International terminology standards Preparation and layout
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
ISO 8835-3:2007 Inhalational anaesthesia systems Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
DIN EN 60601-1-1 : 2002 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
DIN EN ISO 18777:2009-07 TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 8359:1996 Oxygen concentrators for medical use Safety requirements
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
VDE 0750-1-2 : 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES REQUIREMENTS AND TESTS (IEC 60601-1-2:2014)
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
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
ISO 18777:2005 Transportable liquid oxygen systems for medical use — Particular requirements
IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
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 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/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
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
DIN EN ISO 8359:2009-08 OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS
DIN EN 20594-1:1995-01 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
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
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
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
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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