EN ISO 80601-2-72:2015
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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)
Withdrawn date
09-30-2018
Published date
09-23-2015
Publisher
ISO 80601-2-72:2015 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:intended for use in the home healthcare environment;intended for use by a lay operator;intended for use with patients who are dependent on mechanical ventilation for their life support.ISO 80601-2-72:2015 is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601‑1 and ISO/IEC 80601 series of standards.
| Committee |
CEN/TC 215
|
| DevelopmentNote |
Supersedes EN ISO 10651-2. (10/2015)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| DS EN ISO 80601-2-72 : 2015 | Identical |
| DIN EN ISO 80601-2-72 E : 2016 | Identical |
| UNE-EN ISO 80601-2-72:2015 | Identical |
| DIN EN ISO 80601-2-72:2016-04 | Identical |
| NEN EN ISO 80601-2-72 : 2015 | Identical |
| UNI EN ISO 80601-2-72 : 2015 | Identical |
| ISO 80601-2-72:2015 | Identical |
| SS-EN ISO 80601-2-72:2015 | Identical |
| SN EN ISO 80601-2-72:2016 | Identical |
| NS EN ISO 80601-2-72 : 2015 | Identical |
| BS EN ISO 80601-2-72:2015 | Identical |
| PN EN ISO 80601-2-72 : 2016 | Identical |
| NF EN ISO 80601-2-72 : 2015 | Identical |
| I.S. EN ISO 80601-2-72:2015 | Identical |
| ONORM EN ISO 80601-2-72 : 2016 | Identical |
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| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
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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 |
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| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| 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 10651-3:1997 | Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators |
| 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 |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
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| 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 |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| ISO 80601-2-55:2011 | Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| ISO 17510:2015 | Medical devices — Sleep apnoea breathing therapy — Masks and application accessories |
| ISO 23328-1:2003 | Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance |
| 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 |
| EN 1789:2007+A2:2014 | Medical vehicles and their equipment - Road ambulances |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| 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 |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 11195:1995 | Gas mixers for medical use Stand-alone gas mixers |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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