SIST EN ISO 80601-2-87:2021
(Main)Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021)
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators (ISO 80601-2-87:2021)
This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:
intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator).
NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment.
intended to be operated by a healthcare professional operator;
intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and
capable of providing more than 150 inflations/min.
There are three principal designations of HFV:
high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];
high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and
high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].
Additionally, HFV designations can be combined together or with ventilation at rates less than 150 inflations/min.
* A high-frequency ventilator is not considered a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to an HFV breathing system, or to a high-frequency ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the high-frequency ventilator.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.
NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
non-high-frequency ventilators or accessories which provide conventional ventilation for use in critical care environments, which are given in ISO 80601-2-12 [23];.
NOTE 5 An HFV can incorporate conventional critical care ventilator operational modes, in which case ISO 80601-2-12 is applicable to those modes.
ventilators or accessories intended for anaesthetic applications, which are given in ISO 806
Medizinische elektrische Geräte - Teil 2-87: Besondere Festlegungen an die Sicherheit und die wesentlichen Leistungsmerkmale von Hochfrequenz Beatmungsgeräten (ISO 80601-2-87:2021)
Dieses Dokument gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale eines Hochfrequenz Beatmungsgeräts (HFV, en: High Frequency Ventilator) in Kombination mit dessen Zubehör, nachfolgend als ME Gerät bezeichnet, das:
— für den Gebrauch in einer Umgebung vorgesehen ist, die eine spezielle Pflege für Patienten bietet, deren Zustand lebensgefährlich sein kann und die eine umfassende Pflege sowie ununterbrochene Überwachung in einer professionellen Gesundheitseinrichtung erfordern können;
ANMERKUNG 1 Im Sinne dieses Dokuments wird eine derartige Umgebung eine Intensivpflege Umgebung genannt. Hochfrequenz Beatmungsgeräte für diese Umgebung werden als lebenserhalten angesehen.
ANMERKUNG 2 Für die Anwendung dieses Dokuments kann ein solches Hochfrequenz Beatmungsgerät für den Krankentransport innerhalb einer professionellen Gesundheitseinrichtung eingesetzt werden (d. h. ein Beatmungsgerät sein, das betriebsfähig bei Bewegung ist).
ANMERKUNG 3 Ein Hochfrequenz Beatmungsgerät, das für den Krankentransport innerhalb einer professionellen Gesundheitseinrichtung vorgesehen ist, wird nicht als Beatmungsgerät für eine Umgebung für den Notfalleinsatz betrachtet.
— für den Betrieb durch einen medizinisch ausgebildeten Bediener vorgesehen ist;
— für Patienten vorgesehen ist, die unterschiedlich starke Unterstützung durch künstliche Beatmung benötigen, einschließlich vom Gerät abhängiger Patienten;
— mehr als 150 Aufblähungen/min bereitstellen kann.
Es gibt hauptsächlich drei Bezeichnungen für HFV:
— perkussive Hochfrequenz Beatmung (HFPV, en: High Frequency Percussive Ventilation, mit einer typischen HFV Frequenz von (60 bis 1 000) HFV Aufblähungen/min);
— Hochfrequenz Jet Beatmung (HFJV, en: High Frequency Jet Ventilation, mit einer typischen HFV Frequenz von (100 bis 1 500) HFV Aufblähungen/min);
— Hochfrequenz Oszillations Beatmung (HFOV, en: High Frequency Oscillatory Ventilation, mit einer typischen HFV Frequenz von (180 bis 1 200) HFV Aufblähungen/min und typischerweise einer aktiven Exspirationsphase).
Darüber hinaus können die HFV Bezeichnungen untereinander oder mit einer Beatmung mit einer Frequenz von weniger als 150 Aufblähungen/min kombiniert werden.
* Für Hochfrequenz Beatmungsgeräte wird keine Verwendung von physiologischen geschlossenen Regelsystemen angenommen, es sei denn, es wird eine physiologische Patientenvariable verwendet, um die Einstellungen des Beatmungsgeräts anzupassen.
Appareils électromédicaux - Partie 2-87: Exigences particulières pour la sécurité de base et les performances essentielles des ventilateurs à haute fréquence (ISO 80601-2-87:2021)
Le présent document s’applique à la sécurité de base et aux performances essentielles d’un ventilateur à haute fréquence (HFV) associé à ses accessoires, ci-après désignés par appareil EM:
prévu pour une utilisation dans un environnement qui fournit des soins spécialisés aux patients dont l’état de santé peut mettre leur vie en danger et qui peuvent exiger des soins complets et une surveillance constante dans un établissement de soins professionnel;
NOTE 1 Pour les besoins du présent document, un environnement de cette nature est appelé «environnement de soins intensifs». Les ventilateurs à haute fréquence pour un tel environnement sont considérés comme essentiels au maintien de la vie.
NOTE 2 Pour les besoins du présent document, un tel ventilateur à haute fréquence peut être associé au transport à l’intérieur d’un établissement de soins professionnel (c’est-à-dire être un ventilateur opérationnel en déplacement).
NOTE 3 Un ventilateur à haute fréquence destiné à être utilisé lors de transports à l’intérieur d’un établissement de soins professionnel n’est pas considéré comme un ventilateur pour l’environnement des services médicaux d’urgence.
prévu pour être utilisé par un opérateur professionnel de soins de santé;
prévu pour les patients qui nécessitent différents niveaux d’aide par ventilation artificielle, y compris les patients ventilo-dépendants; et
capable d’assurer plus de 150 insufflations/min.
Il existe trois dénominations principales pour désigner les systèmes HFV:
ventilation à haute fréquence par percussion [HFPV, avec une fréquence HFV type de (60 à 1 000) insufflations HFV/min];
jet-ventilation à haute fréquence [HFJV, avec une fréquence HFV type de (100 à 1 500) insufflations HFV/min]; et
ventilation par oscillations à haute fréquence [HFOV, avec une fréquence HFV type de (180 à 1 200) insufflations HFV/min et généralement dotée d’une phase expiratoire active].
En outre, les dénominations des systèmes HFV peuvent être associées ensemble ou avec une ventilation à des fréquences inférieures à 150 insufflations/min.
* Un ventilateur à haute fréquence n’est pas considéré comme un système physiologique de commande en boucle fermée, à moins qu’il n’utilise une variable physiologique du patient pour ajuster les paramètres de traitement par ventilation.
Le présent document s’applique également aux accessoires conçus par leur fabricant pour être raccordés à un système respiratoire HFV ou à un ventilateur à haute fréquence, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles du ventilateur à haute fréquence.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d’application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l’exception des alinéas 7.2.13 et 8.4.1 de l’IEC 60601‑1:2005.
NOTE 4 Des informations supplémentaires sont disponibles en 4.2 de l’IEC 60601-1:2005+AMD1:2012.
Le présent document ne s’applique pas aux appareils EM uniquement destinés à augmenter la ventilation des patients respira
Medicinska električna oprema - 2-87. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokofrekvenčnega ventilatorja (ISO 80601-2-87:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2021
Medicinska električna oprema - 2-87. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti visokofrekvenčnega ventilatorja (ISO 80601-2-87:2021)
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and
essential performance of high-frequency ventilators (ISO 80601-2-87:2021)
Medizinische elektrische Geräte - Teil 2-87: Besondere Festlegungen an die Sicherheit
und die wesentlichen Leistungsmerkmale von Hochfrequenz Beatmungsgeräten (ISO
80601-2-87:2021)
Appareils électromédicaux - Partie 2-87: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs à haute fréquence (ISO 80601-2-
87:2021)
Ta slovenski standard je istoveten z: EN ISO 80601-2-87:2021
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 80601-2-87
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-87: Particular
requirements for basic safety and essential performance of
high-frequency ventilators (ISO 80601-2-87:2021)
Appareils électromédicaux - Partie 2-87: Exigences Medizinische elektrische Geräte - Teil 2-87: Besondere
particulières pour la sécurité de base et les Festlegungen an die Sicherheit und die wesentlichen
performances essentielles des ventilateurs à haute Leistungsmerkmale von Hochfrequenz
fréquence (ISO 80601-2-87:2021) Beatmungsgeräten (ISO 80601-2-87:2021)
This European Standard was approved by CEN on 2 April 2021.
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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-87:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-87:2021) 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 October 2021, and conflicting national standards shall
be withdrawn at the latest by October 2021.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-87:2021 has been approved by CEN as EN ISO 80601-2-87:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-87
First edition
2021-04
Medical electrical equipment —
Part 2-87:
Particular requirements for basic
safety and essential performance of
high-frequency ventilators
Appareils électromédicaux —
Partie 2-87: Exigences particulières pour la sécurité de base et les
performances essentielles des ventilateurs à haute fréquence
Reference number
ISO 80601-2-87:2021(E)
©
ISO 2021
ISO 80601-2-87:2021(E)
© ISO 2021
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 the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 80601-2-87:2021(E)
Contents
201.1 Scope, object and related standards . 1
201.2 Normative references . 4
201.3 Terms and definitions. 6
201.4 General requirements . 21
201.5 General requirements for testing of ME equipment . 28
201.6 Classification of ME equipment and ME systems . 29
201.7 ME equipment identification, marking and documents . 29
201.8 Protection against electrical hazards from ME equipment . 35
201.9 Protection against mechanical hazards of ME equipment and ME systems . 36
201.10 Protection against unwanted and excessive radiation hazards . 39
201.11 Protection against excessive temperatures and other hazards . 39
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 43
201.13 Hazardous situations and fault conditions for ME equipment . 60
201.14 Programmable electrical medical systems (PEMS) . 62
201.15 Construction of ME equipment . 62
201.16 ME systems . 66
201.17 Electromagnetic compatibility of ME equipment and ME systems . 66
201.101 Gas connections . 66
201.102 Requirements for the HFV breathing system and accessories . 68
201.103 * Spontaneous breathing during loss of power supply . 70
201.104 * Indication of duration of operation . 70
201.105 Functional connection . 71
201.106 Display loops . 71
201.107 Timed high-frequency oscillation pause . 72
202 Electromagnetic disturbances – Requirements and tests . 72
206 Usability . 73
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 75
Annex C (informative) Guide to marking and labelling requirements for ME equipment
and ME systems . 77
Annex D (informative) Symbols on marking . 82
Annex AA (informative) Particular guidance and rationale. 83
Annex BB (informative) Data interface requirements . 113
Annex CC (informative) Reference to the IMDRF essential principles and labelling
guidances . 119
Annex DD (informative) Reference to the essential principles . 122
ISO 80601-2-87:2021(E)
Annex EE (informative) Reference to the general safety and performance requirements
................................................................................................................................................. 125
Annex FF (informative) Terminology — alphabetized index of defined terms . 128
Bibliography . 133
iv © ISO 2021 – All rights reserved
ISO 80601-2-87:2021(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International
Electrotechnical Commission) form the specialized system for worldwide standardization.
National bodies that are members of ISO or IEC participate in the development of International
Standards through technical committees established by the respective organization to deal with
particular fields of technical activity. ISO and IEC technical committees collaborate in fields of
mutual interest. Other international organizations, governmental and non-governmental, in
liaison with ISO and IEC, also take part in the work.
The procedures used to develop this document and those intended for its further maintenance
are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria
needed for the different types of document should be noted. This document was drafted in
accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the
subject of patent rights. ISO and IEC shall not be held responsible for identifying any or all such
patent rights. Details of any patent rights identified during the development of the document will
be in the Introduction and/or on the ISO list of patent declarations received (see
www.iso.org/patents) or the IEC list of patent declarations received (see http://patents.iec.ch).
Any trade name used in this document is information given for the convenience of users and does
not constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee SC 3, Respiratory devices and related equipment used for
patient care, and Technical Committee IEC/TC 62, Electrical equipment in medical practice,
Subcommittee SC 62D, Electromedical equipment, in collaboration with the European Committee
for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
A list of all parts in the ISO 80601 series and the IEC 80601 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards
body. A complete listing of these bodies can be found at www.iso.org/members.html.
ISO 80601-2-87:2021(E)
Introduction
In this document, the following print types are used:
– Requirements and definitions: roman type;
– Instructions, test specifications and terms defined in Clause 3 of the general standard, in this
document or as noted: italic type;
...
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