EN ISO 18778:2022
(Main)Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)
Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors (ISO 18778:2022)
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and
— intended for transit-operable use.
NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.
EXAMPLE probes, cables distributed alarm system
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von kardiorespiratorischen Überwachungsgeräten für Kleinkinder (ISO 18778:2022)
Dieses Dokument ist anzuwenden für die Basissicherheit und die wesentlichen Leistungsmerkmale von kardiorespiratorischen Überwachungsgeräten für Kleinkinder, wie in 3.10 definiert, im Folgenden auch als ME-Geräte bezeichnet, in Kombination mit ihrem Zubehör:
— für die medizinische Versorgung in häuslicher Umgebung vorgesehen;
— zur Benutzung durch einen nicht fachkundigen Bediener bestimmt;
— zur Überwachung kardiorespiratorischer Parameter bei schlafenden oder ruhenden Kindern unter drei Jahren vorgesehen;
— für den bei Bewegung betriebsfähigen Gebrauch vorgesehen.
ANMERKUNG Kardiorespiratorische Überwachungsgeräte für Kleinkinder können auch in gewerblichen Gesundheitseinrichtungen verwendet werden.
Dieses Dokument gilt auch für Zubehör, für das der Hersteller den Anschluss an ein kardiorespiratorisches Überwachungsgerät für Kleinkinder vorsieht, bei dem die Merkmale dieses Zubehörs die Basissicherheit oder die wesentlichen Leistungsmerkmale des kardiorespiratorischen Überwachungsgeräts für Kleinkinder beein¬flussen können.
BEISPIEL Sonden, Kabel verteiltes Alarmsystem
Matériel respiratoire - Exigences particulières relatives à la sécurité de base et aux performances essentielles des moniteurs cardiorespiratoires pour nourrissons (ISO 18778:2022)
Le présent document s’applique à la sécurité de base et aux performances essentielles des moniteurs cardiorespiratoires pour nourrissons, tels que définis en 3.10, ci-après également désignés appareils EM, lorsqu’ils sont associés à leurs accessoires:
— destinés à être utilisés dans l’environnement des soins à domicile;
— destinés à être utilisés par un opérateur non spécialiste;
— destinés à la surveillance des paramètres cardiorespiratoires chez les enfants de moins de trois ans endormis ou au repos; et
— destinés à être opérationnels en déplacement.
NOTE Un moniteur cardiorespiratoire pour nourrissons peut également être utilisé dans les établissements de soins professionnels.
Le présent document s’applique également aux accessoires conçus par leur fabricant pour être raccordés à un moniteur cardiorespiratoire pour nourrissons, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles du moniteur cardiorespiratoire pour nourrissons.
EXEMPLE sondes, câbles système d’alarme réparti.
Respiratorna oprema - Posebne zahteve za osnovno varnost in bistveno učinkovitost opreme za kardiorespiratorne monitorje za otroke (ISO 18778:2022)
Ta dokument se uporablja za osnovno varnost in bistveno učinkovitost opreme za kardiorespiratorne monitorje za otroke,
kot je opredeljeno v točki 3.10, v nadaljevanju poimenovane tudi elektromedicinska oprema, in sicer skupaj z dodatno opremo, ki je namenjena:
– za uporabo v okolju domače zdravstvene oskrbe;
– nestrokovnjakom;
– za spremljanje kardiorespiratornih parametrov pri otrocih, ki spijo ali počivajo in so mlajši
od treh let; ter
– za delovanje med nošenjem.
OPOMBA: Oprema za kardiorespiratorne monitorje za otroke se lahko uporablja tudi v zdravstvenih ustanovah.
Ta dokument se uporablja tudi za dodatno opremo, ki jo je proizvajalec predvidel za priklop na
opremo za kardiorespiratorne monitorje za otroke, pri čemer lahko lastnosti te dodatne opreme vplivajo na osnovno
varnost ali bistvene lastnosti opreme za kardiorespiratorne monitorje za otroke.
PRIMER: Sonde, kabli, distribuiran alarmni sistem.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2023
Nadomešča:
SIST EN ISO 18778:2009
Respiratorna oprema - Posebne zahteve za osnovno varnost in bistveno
učinkovitost opreme za kardiorespiratorne monitorje za otroke (ISO 18778:2022)
Respiratory equipment - Particular requirements for basic safety and essential
performance of infant cardiorespiratory monitors (ISO 18778:2022)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von kardiorespiratorischen
Überwachungsgeräten für Kleinkinder (ISO 18778:2022)
Matériel respiratoire - Exigences particulières relatives à la sécurité de base et aux
performances essentielles des moniteurs cardiorespiratoires pour nourrissons (ISO
18778:2022)
Ta slovenski standard je istoveten z: EN ISO 18778:2022
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 18778
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 11.040.10; 11.040.55 Supersedes EN ISO 18778:2009
English Version
Respiratory equipment - Particular requirements for basic
safety and essential performance of infant
cardiorespiratory monitors (ISO 18778:2022)
Matériel respiratoire - Exigences particulières relatives Medizinische elektrische Geräte - Besondere
à la sécurité de base et aux performances essentielles Festlegungen für die Sicherheit einschließlich der
des moniteurs cardiorespiratoires pour nourrissons wesentlichen Leistungsmerkmale von
(ISO 18778:2022) kardiorespiratorischen Überwachungsgeräten für
Kleinkinder (ISO 18778:2022)
This European Standard was approved by CEN on 17 June 2022.
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18778:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18778:2022) 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 April 2023, and conflicting national standards shall be
withdrawn at the latest by April 2023.
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 18778:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
Endorsement notice
The text of ISO 18778:2022 has been approved by CEN as EN ISO 18778:2022 without any modification.
INTERNATIONAL ISO
STANDARD 18778
Second edition
2022-06
Respiratory equipment — Particular
requirements for basic safety and
essential performance of infant
cardiorespiratory monitors
Matériel respiratoire — Exigences particulières relatives à la
sécurité de base et aux performances essentielles des moniteurs
cardiorespiratoires pour nourrissons
Reference number
ISO 18778:2022(E)
ISO 18778:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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Email: copyright@iso.org
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Published in Switzerland
ii
ISO 18778:2022(E)
Contents Page
Foreword . vi
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 6
4.1 General . 6
4.2 Essential performance . 6
4.3 ME equipment or ME system parts that contact the patient . 6
4.4 Single fault condition for ME equipment . 6
5 General requirements for testing of ME equipment . 6
5.1 General . 6
5.2 Infant cardiorespiratory monitor testing errors . 6
6 Classification of ME equipment and ME systems. 7
6.1 General . 7
6.2 Additional requirements for classification of ME equipment and ME systems . 7
7 ME equipment identification, marking and documents. 7
7.1 General . 7
7.2 Information to be supplied by the manufacturer . 7
7.3 Additional requirements for accessories . 7
7.4 Additional requirements for marking on the outside of ME equipment or
ME equipment parts . 8
7.5 General instructions for use . 8
7.6 Additional requirements for warnings and safety notices . 8
7.7 Additional requirements for start-up procedure . 9
7.8 Additional requirements for operating instructions . 9
7.8.1 General . 9
7.8.2 Lay operator operating instructions . 9
7.8.3 Healthcare professional operator operating instructions . 10
7.9 Cleaning, disinfection, and sterilization . 10
7.10 Additional requirements for maintenance . 10
7.11 Additional requirements for accessories, supplementary equipment, used material . 10
7.12 Additional requirements for the technical description . 10
8 Protection against electrical hazards from ME equipment .11
9 Protection against mechanical hazards of ME equipment and ME systems.11
9.1 General . 11
9.2 Additional requirements for instability from unwanted lateral movement . 11
9.3 Grips and other handling devices . 11
10 Protection against unwanted and excessive radiation hazards .11
11 Protection against excessive temperatures and other hazards .11
11.1 General . 11
11.2 Cleaning and disinfection of ME equipment or ME system .12
11.3 Sterilization of ME equipment or ME system .12
11.4 Biocompatibility of ME equipment and ME systems .12
11.5 Interruption of the power supply / supply mains to ME equipment .13
11.5.1 General .13
11.5.2 Power sources . 13
11.5.3 Alternative power supply/supply mains .
...
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