Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)

Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires - Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)

Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs de gaz respiratoires - Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)

Medicinska električna oprema - 2-55. del: Posebne zahteve za osnovno varnost in bistvene lastnosti monitorjev dihalnih plinov - Dopolnilo A1 (ISO 80601-2-55:2018/Amd 1:2023)

General Information

Status
Published
Public Enquiry End Date
19-Apr-2023
Publication Date
08-Feb-2024
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Jan-2024
Due Date
30-Mar-2024
Completion Date
09-Feb-2024

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 80601-2-55:2018/A1:2024
01-marec-2024
Medicinska električna oprema - 2-55. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti monitorjev dihalnih plinov - Dopolnilo A1 (ISO 80601-2-
55:2018/Amd 1:2023)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and
essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-
55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des moniteurs de gaz respiratoires -
Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des moniteurs de gaz respiratoires -
Amendement 1 (ISO 80601-2-55:2018/Amd 1:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-55:2018/A1:2023
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-55:2018/A1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-55:2018/A1:2024

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SIST EN ISO 80601-2-55:2018/A1:2024


EN ISO 80601-2-
EUROPEAN STANDARD
55:2018/A1
NORME EUROPÉENNE

EUROPÄISCHE NORM

December 2023
ICS 11.040.10
English Version

Medical electrical equipment - Part 2-55: Particular
requirements for the basic safety and essential
performance of respiratory gas monitors - Amendment 1
(ISO 80601-2-55:2018/Amd 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences Medizinische elektrische Geräte - Teil 2 55: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des moniteurs de gaz wesentlichen Leistungsmerkmale von
respiratoires - Amendement 1 (ISO 80601-2- Überwachungsgeräten für Atemgase - Änderung 1 (ISO
55:2018/Amd 1:2023) 80601-2-55:2018/Amd 1:2023)
This amendment A1 modifies the European Standard EN ISO 80601-2-55:2018; it was approved by CEN on 6 June 2023.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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 80601-2-55:2018/A1:2023 E
worldwide for CEN national Members.

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SIST EN ISO 80601-2-55:2018/A1:2024
EN ISO 80601-2-55:2018/A1:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 80601-2-55:2018/A1:2024
EN ISO 80601-2-55:2018/A1:2023 (E)
European foreword
This document (EN ISO 80601-2-55:2018/A1:2023) 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 Amendment to the European Standard EN ISO 80601-2-55:2018 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by June
2024, and conflicting national standards shall be withdrawn at the latest by June 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.
Any feedback and questions on this document should be dir
...

SLOVENSKI STANDARD
SIST EN ISO 80601-2-55:2018/oprA1:2023
01-april-2023
Medicinska električna oprema - 2-55. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti monitorjev dihalnih plinov - Dopolnilo A1 (ISO 80601-2-
55:2018/DAM 1:2023)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and
essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-
55:2018/DAM 1:2023)
Medizinische elektrische Geräte - Teil 2 55: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Überwachungsgeräten für
Atemgase - Änderung 1 (ISO 80601 2 55:2018/DAM 1:2023)
Appareils électromédicaux - Partie 2-55: Exigences particulières relatives à la sécurité
de base et aux performances essentielles des moniteurs de gaz respiratoires -
Amendement 1 (ISO 80601-2-55:2018/DAM 1:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-55:2018/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2- en,fr,de
55:2018/oprA1:2023
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 80601-2-55:2018/oprA1:2023

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SIST EN ISO 80601-2-55:2018/oprA1:2023
DRAFT AMENDMENT
ISO 80601-2-55:2018/DAM 1
ISO/TC 121/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-02-10 2023-05-05
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic safety and essential
performance of respiratory gas monitors
AMENDMENT 1
Appareils électromédicaux —
Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des
moniteurs de gaz respiratoires
AMENDEMENT 1
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 80601-2-55:2018/DAM 1:2023(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 2023

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SIST EN ISO 80601-2-55:2018/oprA1:2023
ISO 80601-2-55:2018/DAM 1:2023(E)
DRAFT AMENDMENT
ISO 80601-2-55:2018/DAM 1
ISO/TC 121/SC 1 Secretariat: DIN
Voting begins on: Voting terminates on:
Medical electrical equipment —
Part 2-55:
Particular requirements for the basic safety and essential
performance of respiratory gas monitors
AMENDMENT 1
Appareils électromédicaux —
Partie 2-55: Exigences particulières relatives à la sécurité de base et aux performances essentielles des
moniteurs de gaz respiratoires
AMENDEMENT 1
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.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
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STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO 80601-2-55:2018/DAM 1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHT
...

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