SIST EN ISO 80601-2-72:2023

Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)

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.

Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom Gerät abhängige Patienten (ISO 80601-2-72:2023)

No scope available

Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base et les performances essentielles des ventilateurs utilisés dans l'environnement des soins à domicile pour les patients ventilo-dépendants (ISO 80601-2-72:2023)

L'ISO 80601-2-72:2015 s'applique à la sécurité de base et aux performances essentielles d'un ventilateur associé à ses accessoires, ci-après désignés par appareil em:
destiné à être utilisé dans l'environnement des soins à domicile;
destiné à être utilisé par un opérateur non spécialiste;
destiné à être utilisé avec des patients dépendants d'une ventilation mécanique pour le maintien de leurs fonctions vitales.
L'ISO 80601-2-72:2015 s'applique également aux accessoires conçus par leur fabricant pour être raccordés à un système respiratoire de ventilateur ou à un ventilateur, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles du ventilateur.
L'ISO 80601-2-72:2015 est une Norme internationale particulière dans la série de normes IEC 60601‑1 et ISO/IEC 80601.

Medicinska električna oprema - 2-72. del: Posebne zahteve za osnovno varnost in bistvene lastnosti respiratorjev za oskrbo od aparata odvisnih pacientov na domu (ISO 80601-2-72:2023)

Standard ISO 80601-2-72:2015 se uporablja za osnovno varnost in bistvene lastnosti respiratorjev v kombinaciji z dodatno opremo, v nadaljevanju: elektromedicinska oprema:
   za uporabo v okolju domače zdravstvene oskrbe;
   ki je namenjena nestrokovnjakom;
   namenjena pacientom, ki so odvisni od mehanskega respiratorja za ohranjanje pri življenju.
Standard ISO 80601-2-72:2015 se uporablja tudi za tisto dodatno opremo, ki jo je proizvajalec predvidel za priklop na ventilatorski dihalni sistem ali respirator, pri čemer lahko lastnosti te dodatne opreme vplivajo na osnovno varnost ali bistvene lastnosti respiratorja.
Standard ISO 80601-2-72:2015 je posamezni mednarodni standard iz skupin standardov IEC 60601‑1 in ISO/IEC 80601.

General Information

• Status: Published
• Public Enquiry End Date: 29-Jun-2022
• Publication Date: 13-Sep-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Aug-2023
• Due Date: 06-Oct-2023
• Completion Date: 14-Sep-2023
• Ref Project: EN ISO 80601-2-72:2023 - Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)

Relations

• Replaces: SIST EN ISO 80601-2-72:2015 - 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)
• Effective Date: 01-Sep-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80601-2-72:2023
01-oktober-2023
Nadomešča:
SIST EN ISO 80601-2-72:2015
Medicinska električna oprema - 2-72. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti respiratorjev za oskrbo od aparata odvisnih pacientov na domu
(ISO 80601-2-72:2023)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and
essential performance of home healthcare environment ventilators for ventilator-
dependent patients (ISO 80601-2-72:2023)
Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom
Gerät abhängige Patienten (ISO 80601-2-72:2023)
Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs utilisés dans l'environnement des soins
à domicile pour les patients ventilo-dépendants (ISO 80601-2-72:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-72:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-72:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-72:2023

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SIST EN ISO 80601-2-72:2023


EN ISO 80601-2-72
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-72:2015
English Version

Medical electrical equipment - Part 2-72: Particular
requirements for basic safety and essential performance of
home healthcare environment ventilators for ventilator-
dependent patients (ISO 80601-2-72:2023)
Appareils électromédicaux - Partie 2-72: Exigences Medizinische elektrische Geräte - Teil 2-72: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs utilisés wesentlichen Leistungsmerkmale von
dans l'environnement des soins à domicile pour les Heimbeatmungsgeräten für vom Gerät abhängige
patients ventilo-dépendants (ISO 80601-2-72:2023) Patienten (ISO 80601-2-72:2023)
This European Standard was approved by CEN on 24 April 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-72:2023 E
worldwide for CEN national Members.

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SIST EN ISO 80601-2-72:2023
EN ISO 80601-2-72:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 80601-2-72:2023
EN ISO 80601-2-72:2023 (E)
European foreword
This document (EN ISO 80601-2-72:2023) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 806
...

SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-72:2022
01-junij-2022
Medicinska električna oprema - 2-72. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti respiratorjev za oskrbo od aparata odvisnih pacientov na domu
(ISO/DIS 80601-2-72:2022)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and
essential performance of home healthcare environment ventilators for ventilator-
dependent patients (ISO/DIS 80601-2-72:2022)
Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom
Gerät abhängige Patienten (ISO/DIS 80601-2-72:2022)
Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs utilisés dans l'environnement des soins
à domicile pour les patients ventilo-dépendants (ISO/DIS 80601-2-72:2022)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-72
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-72:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 80601-2-72:2022

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oSIST prEN ISO 80601-2-72:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-72
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-04-26 2022-07-19
Medical electrical equipment —
Part 2-72:
Particular requirements for basic safety and essential
performance of home healthcare environment ventilators
for ventilator-dependent patients
Appareils électromédicaux —
Partie 2-72: Exigences particulières pour la sécurité de base et les performances essentielles des
ventilateurs utilisés dans l'environnement des soins à domicile pour les patients ventilo-dépendants
ICS: 11.040.10
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 80601-2-72:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

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oSIST prEN ISO 80601-2-72:2022
© ISO/IEC 2022 – All rights reserved
ISO/DIS 80601-2-72:2022(E)
ISO/TC 121/SC 3/
Date: 2022-02-21
ISO 80601-2-72 (Ed 2)
ISO/IEC TC 121/SC 3/JWG 12
Secretariat: ANSI
Medical electrical equipment — Part 2-72: Particular requirements for
basic safety and essential performance of home healthcare environment
ventilators for ventilator-dependent patients
Appareils électromédicaux — Partie 2-72: Exigences particulières pour la sécurité de base et les
performances essentielles des ventilateurs d'environnement de soins de santé à domicile pour les
patients qui en sont dépendants

DIS stage

Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is
subject to change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent
rights of which they are aware and to provide supporting documentation.


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ii
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oSIST prEN ISO 80601-2-72:2022
ISO 80601-2-72:2022(E)
1 Contents Page
2 CS will add the contents table at the FDIS stage.
3
4
© ISO 2022 – All rights reserv
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