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EVS-EN ISO 10651-2:2009

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients

General information

Withdrawn from 06.10.2015
Base Documents
ISO 10651-2:2004; EN ISO 10651-2:2009
ICS Groups
11.040.10 Anaesthetic, respiratory and reanimation equipment
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
06.10.2015
Main
EVS-EN ISO 80601-2-72:2015
04.06.2009
Main
EVS-EN ISO 10651-2:2009
Main
EVS-EN ISO 10651-2:2004
This part of ISO 10651 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.

Required fields are indicated with *

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Standard monitoring
English (PDF 403 KB)

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EVS-EN ISO 80601-2-72:2015

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EVS-EN ISO 80369-1:2018

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EVS-EN ISO 80601-2-12:2020

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
Withdrawn from 01.12.2023

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