I.S. EN ISO 10651-2:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
Hardcopy , PDF
12-10-2015
English
01-01-2009
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements and requirements for tests
5 Classification
6 Identification, marking and documents
7 Power input
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not used
12 Not used
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 Enclosures and protective covers
17 Separation
18 Protective earthing, functional earthing and potential
equalization
19 Continuous leakage currents and patient auxiliary currents
20 Dielectric strength
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in normal use
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
29 X-radiation
30 Alpha, beta, gamma, neutron radiation and other
particle radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red-radiation
34 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
37 Locations and basic requirements
38 Marking, accompanying documents
39 Common requirements for category AP and category
APG equipment
40 Requirements and tests for category AP equipment,
parts and components thereof
41 Requirements and tests for category APG equipment,
parts and components thereof
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
cleaning, sterilization, disinfection and compatibility
45 Pressure vessels and parts subject to pressure
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
50 Accuracy of operating data
51 Protection against hazardous output
52 Abnormal operation and fault conditions
53 Environmental tests
54 General
55 Enclosures and covers
56 Components and general assembly
57 Mains parts, components and layout
58 Protective earthing - Terminals and connections
59 Construction and layout
101 Alarm systems
102 Appendices of IEC 60601-1:1988
Annex AA (informative) - Rationale
Annex BB (informative) - Reference to the essential principles
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42 EEC
Describes requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support.
| DevelopmentNote |
Supersedes I.S. EN 794-2 (09/2004)
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NEN EN ISO 10651-2 : 2009 | Identical |
| NBN EN ISO 10651-2 : 2009 | Identical |
| EN ISO 10651-2:2009 | Identical |
| DIN EN ISO 10651-2:2011-06 | Identical |
| UNE-EN ISO 10651-2:2009 | Identical |
| SN EN ISO 10651-2 : 2009 | Identical |
| ISO 10651-2:2004 | Identical |
| NF EN ISO 10651-2 : 2009 | Identical |
| NS EN ISO 10651-2 : 2009 | Identical |
| BS EN ISO 10651-2:2004 | Identical |
| UNI EN ISO 10651-2 : 2009 | Identical |
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| 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 9703-1:1992 | Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals |
| 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 |
| ISO 8359:1996 | Oxygen concentrators for medical use Safety requirements |
| ISO 15001:2010 | Anaesthetic and respiratory equipment Compatibility with oxygen |
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| NFPA 53 : 2016 | MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES |
| 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 |
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| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
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| 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 |
| IEC 60601-2-13:2003+AMD1:2006 CSV | Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems |
| 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 |
| IEC 80416-1:2008 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration |
| ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| IEEE DRAFT 1073 : D3.6 SEP 95 | STANDARD FOR MEDICAL DEVICE COMMUNICATIONS OVERVIEW AND FRAMEWORK |
| 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 |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| 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 |
| 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 |
| 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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