DIN EN ISO 10651-6:2011-06
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
Hardcopy , PDF
03-07-2021
English
01-01-2011
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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 |
| Standards | Relationship |
| NEN EN ISO 10651-6 : 2009 | Identical |
| ISO 10651-6:2004 | Identical |
| SN EN ISO 10651-6 : 2009 | Identical |
| NBN EN ISO 10651-6 : 2009 | Identical |
| NS EN ISO 10651-6 : 2009 | Identical |
| NF EN ISO 10651-6 : 2009 | Identical |
| EN ISO 10651-6:2009 | Identical |
| UNI EN ISO 10651-6 : 2009 | Identical |
| UNE-EN ISO 10651-6:2009 | Identical |
| BS EN ISO 10651-6:2009 | Identical |
| I.S. EN ISO 10651-6:2009 | Identical |
| 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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