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EVS-EN ISO 10651-6:2009

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices

General information

Withdrawn from 02.01.2020
Base Documents
ISO 10651-6:2004; EN ISO 10651-6:2009
ICS Groups
11.040.10 Anaesthetic, respiratory and reanimation equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.10.2019
Main
EVS-EN ISO 80601-2-80:2019
01.10.2019
Main
EVS-EN ISO 80601-2-79:2019
04.06.2009
Main
EVS-EN ISO 10651-6:2009
Main
EVS-EN ISO 10651-6:2004
This part of ISO 10651 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 healthcare facilities) for appropriate  patients for whom the use of a home-care  ventilator complying with ISO 10651-2 is not required. The requirements of this part of ISO 10651 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.

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Standard monitoring
English (PDF 398 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English