Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Secure PDF 🔒
    • 👥
    • Immediate download
    • $398.78
    • Add to Cart
    • Printed Edition
    • Ships in 1-2 business days
    • $398.78
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $538.48
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, for VENTILATORY INSUFFICIENCY, as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT, in combination with its ACCESSORIES:

— intended for use in the HOME HEALTHCARE ENVIRONMENT;
— intended for use by a LAY OPERATOR;
— intended for use with PATIENTS who have VENTILATORY INSUFFICIENCY or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
— intended for TRANSIT-OPERABLE use;
— not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support.

EXAMPLE 1 PATIENTS with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.

NOTE 1 In the HOME HEALTHCARE ENVIRONMENT, the SUPPLY MAINS is often not reliable.

NOTE 2 Such VENTILATORY SUPPORT EQUIPMENT can also be used in non-critical care applications of professional health care facilities.

This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to the VENTILATOR BREATHING SYSTEM of VENTILATORY SUPPORT EQUIPMENT for VENTILATORY INSUFFICIENCY, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT for VENTILATORY INSUFFICIENCY.

EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external electrical power source, DISTRIBUTED ALARM SYSTEM.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Cross References:
ISO 17664:2017
ISO 80369-7:2016
IEC 61672-1:2013
ISO 18562-1:2017
ISO 7396-1:2016
ISO 4135:2001
ISO 4871:1996
ISO 8836:2014
ISO 9360-2:2001
IEC 60601-1-8:2006
EN 15986:2011
ISO 80369-1:2010
ISO 5367:2014
IEC 62366-1:2015
ISO 23328-2:2002
ISO 80601-2-72:2015
IEC 60601-1-11:2015
ISO 7000:2012
IEC 60601-1-2:2014
ISO 9360-1:2000
ISO 17510:2015
IEC 60601-1:2005/AMD1:2012
ISO 9000:2015
ISO 15223-1:2016
ISO 80601-2-74:2017
ISO 5356-1:2015
ISO 3744:2010
ISO 16142-1:2016
ISO 23328-1:2003
ISO 80601-2-12:2011
IEC 60601-1-6:2010
ISO 80601-2-79:2018
IEC TR 60878:2015
ISO 80601-2-13:2011
IEC 60601-1-3:2008
ISO 10651-6
ISO 80601-2-84
IEC 80601-2-70:2015
TR 21954
ISO 80369-2
ISO 10524-1
ISO 14159
ISO 10651-3
ISO 639-1


Incorporates the following:
Corrigendum, September 2019
 

Document History

  1. BS EN ISO 80601-2-80:2019

    👀currently
    viewing


    Medical electrical equipment-Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

    • Most Recent
  2. BS EN ISO 10651-6:2009


    Lung ventilators for medical use. Particular requirements for basic safety and essential performance-Home-care ventilatory support devices

    • Historical Version
  3. BS EN ISO 10651-6:2004


    Lung ventilators for medical use. Particular requirements for basic safety and essential performance-Home-care ventilatory support devices

    • Historical Version