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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Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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Withdrawn date

30-09-2018

Published date

23-09-2015

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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Withdrawn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

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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
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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
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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
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