ISO 10651-6:2004
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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 , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
03-12-2019
Language(s)
English, French
Published date
06-28-2004
ISO 10651-6:2004 specifies 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 hospitals) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. It is intended to be used in conjunction with the General Standard IEC 60601-1:1988.
The requirements of ISO 10651-6:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
| DevelopmentNote |
Supersedes ISO/DIS 10651-6. (07/2004) 2004 version partially supersedes ISO 10651-2:1996 (11/2004)
|
| DocumentType |
Standard
|
| Pages |
27
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 10651-6 : 2009 | Identical |
| NEN EN ISO 10651-6 : 2009 | Identical |
| NS EN ISO 10651-6 : 2009 | Identical |
| I.S. EN ISO 10651-6:2009 | Identical |
| PN EN ISO 10651-6 : 2009 | Identical |
| SN EN ISO 10651-6 : 2009 | Identical |
| UNI EN ISO 10651-6 : 2009 | Identical |
| BS EN ISO 10651-6:2009 | Identical |
| UNE-EN ISO 10651-6:2009 | Identical |
| EN ISO 10651-6:2009 | Identical |
| CSA Z10651.6 : 2006 | Identical |
| DIN EN ISO 10651-6:2011-06 | Identical |
| NF EN ISO 10651-6 : 2009 | Identical |
| UNE-EN ISO 10651-6:2005 | Identical |
| CAN/CSA-C22.2 NO. 80601-2-72:17 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (Adopted ISO 80601-2-72:2015, first edition, 2015-09-01, with Canadian deviations) |
| CSA Z17510.1 : 2010 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
| 17/30338753 DC : 0 | BS ISO 80601-2-79 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-79: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY IMPAIRMENT |
| BS EN ISO 80601-2-72:2015 | Medical electrical equipment Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| 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) |
| UNI EN ISO 80601-2-12 : 2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| CSA C22.2 No. 80601-2-12 : 2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| DIN EN ISO 17510-1:2009-07 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| I.S. EN ISO 17510-1:2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
| 15/30300279 DC : 0 | BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT |
| DIN EN ISO 80601-2-72 E : 2016 | 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) |
| 16/30295446 DC : 0 | BS ISO 19223 - LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS |
| I.S. EN ISO 80601-2-12:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
| CSA C22.2 No. 80601-2-12 : 2012(R2017) | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS |
| 17/30338756 DC : 0 | BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY |
| 13/30264413 DC : 0 | BS EN ISO 80601-2-72 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-72: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HOME HEALTHCARE ENVIRONMENT VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS |
| I.S. EN ISO 80601-2-72:2015 | 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) |
| UNI EN ISO 17510-1 : 2009 | SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
| ISO 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
| EN ISO 80601-2-12:2011/AC:2011 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CRITICAL CARE VENTILATORS (ISO 80601-2-12:2011/COR 1:2011) |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| BS EN ISO 17510-1:2009 | Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
| ISO 80601-2-72:2015 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients |
| EN ISO 80601-2-72:2015 | 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) |
| CAN/CSA-C22.2 NO. 80601-2-70:17 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (Adopted ISO 80601-2-70:2015, first edition, 2015-01 , with Canadian deviations) |
| 13/30254355 DC : 0 | BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |
| 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 |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| 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 |
| 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 |
| 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 |
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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 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 |
| IEC 80416-1:2008 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| 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 |
| 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 |
| 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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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
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