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CEN

EN ISO 80601-2-55:2018/A1:2023

(Amendment)

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)

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)

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/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
Publication Date
12-Dec-2023
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
13-Dec-2023
Completion Date
13-Dec-2023
Ref Project
SIST EN ISO 80601-2-55:2018/A1:2024 - 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)

Relations

Amends
EN ISO 80601-2-55:2018 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)
Effective Date
28-Jul-2021

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

---------------------- Page: 1 ----------------------
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

---------------------- Page: 4 ----------------------
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
...

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