ISO 10651-2:2004
Withdrawn
Withdrawn
View Superseded by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
Language(s)
English, French
Published date
06-29-2004
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training.
ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.
ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.
ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.
The requirements of ISO 10651-2:2004 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.
| Committee |
ISO/TC 121/SC 3
|
| DevelopmentNote |
Supersedes ISO/DIS 10651-2 (07/2004) 1996 version also revised by ISO 10651-6. (11/2004)
|
| DocumentType |
Standard
|
| Pages |
31
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 10651-2 : 2009 | Identical |
| NEN EN ISO 10651-2 : 2009 | Identical |
| NS EN ISO 10651-2 : 2009 | Identical |
| I.S. EN ISO 10651-2:2009 | Identical |
| PN EN ISO 10651-2 : 2009 | Identical |
| BS EN ISO 10651-2:2004 | Identical |
| EN ISO 10651-2:2009 | Identical |
| DIN EN ISO 10651-2:2011-06 | Identical |
| NF EN ISO 10651-2 : 2009 | Identical |
| DIN EN ISO 10651-2:2004-10 | Equivalent |
| I.S. EN ISO 10651-2:2004 | Equivalent |
| AS ISO 10651.2-2004 | Identical |
| UNE-EN ISO 10651-2:2009 | Identical |
| UNE-EN ISO 10651-2:2005 | Identical |
| BS EN ISO 10651-2:2009 | Identical |
| BS EN 60601-1-12:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| BS EN ISO 80601-2-12:2011 | Medical electrical equipment Particular requirements for basic safety and essential performance of critical care ventilators |
| 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) |
| EN ISO 17510-1:2009 | 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 |
| 14/30296572 DC : 0 | BS EN 60601-1-11 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| BS EN 60601-2-12:2006 | Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
| 16/30295446 DC : 0 | BS ISO 19223 - LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS |
| CEI EN 60601-2-12 : 2007 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| I.S. EN 60601-1-12:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| EN 60601-1-12:2015 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| ANSI/AAMI HA60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| 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 |
| 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 |
| 12/30245174 DC : 0 | BS EN 60601-1-12 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-12: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS INTENDED FOR USE IN THE EMERGENCY MEDICAL SERVICES ENVIRONMENT |
| 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 |
| 09/30155521 DC : 0 | BS EN 60601-1-11 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| 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) |
| I.S. EN 60601-1-11:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT |
| 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 |
| 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) |
| I.S. EN 60601-2-12:2006 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
| 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 |
| 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) |
| BS EN 60601-1-11:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| ISO 17510-1:2007 | Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment |
| EN 60601-2-12:2006 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
| CSA C22.2 NO. 60601-1-12:15 (R2020) | Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (Adopted IEC 60601-1-12:2014, first edition, 2014-06, with Canadian deviations) | Appareils électromédicaux — Partie 1-12 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l\'environnement des services médicaux d\'urgence (norme IEC 60601-1-12:2014 adoptée, première édition, 2014-06, avec exigences propres au Canada) |
| I.S. EN ISO 80601-2-79:2019&LC:2019 | Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)<br> |
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| ISO 15001:2010 | Anaesthetic and respiratory equipment — Compatibility with oxygen |
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| 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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| 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 |
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| 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 |
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US$96.00
Excluding Tax where applicable
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