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)
ISO 80601-2-87 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; - 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].
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
SIST EN ISO 80601-2-87:2021
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
SIST EN ISO 80601-2-87:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 80601-2-87:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 80601-2-87:2021
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 80601-2-87:2021
EN ISO 80601-2-87:2021 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 80601-2-87:2021
EN ISO 80601-2-87:2021 (E)
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.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 80601-2-87:2021
---------------------- Page: 6 ----------------------
SIST EN ISO 80601-2-87:2021
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
---------------------- Page: 7 ----------------------
SIST EN ISO 80601-2-87:2021
ISO 80601-2-87:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 80601-2-87:2021
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 2021 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 80601-2-87:2021
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
---------------------- Page: 10 ----------------------
SIST EN ISO 80601-2-87:2021
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 2021 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 80601-2-87:2021
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;
– Informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type.
In referring to the structure of this document, the term
– “clause” means one of the four numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all
subclauses of Clause 201).
References to clauses within this document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
For the purposes of this document, the auxiliary verb:
– “shall” means that conformance with a requirement or a test is mandatory for conformance
with this document;
– “should” means that conformance with a requirement or a test is recommended but is not
mandatory for conformance with this document;
– “may” is used to describe permission (e.g. a permissible way to achieve conformance with a
requirement or test);
– "can" is used to describe a possibility or capability; and
– "must" is used to express an external constraint.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
vi © ISO 2021 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 80601-2-87:2021
INTERNATIONAL STANDARD ISO 80601-2-87:2021(E)
Medical electrical equipment —
Part 2-87: Particular requirements for basic safety and essential
performance of high-frequency critical care ventilators
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 * Scope
Replacement:
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].
© ISO 2021 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 80601-2-87:2021
ISO 80601-2-87:2021(E)
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
[23]
in critical care environments, which are given in ISO 80601-2-12 ;.
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
[24]
ISO 80601-2-13 ;
ventilators or accessories intended for the emergency medical services environment, which are
[13]
given in ISO 80601-2-84, the replacement for ISO 10651-3 ;
NOTE 6 An HFV can incorporate EMS ventilator capability.
ventilators or accessories intended for ventilator-dependent patients in the home healthcare
[26]
environment, which are given in ISO 80601-2-72 ;
ventilators or accessories intended for home-care ventilatory support devices, which are
[27] [28] [15]
given in ISO 80601-2-79 and ISO 80601-2-80 , the replacements for ISO 10651-6 ;
[25]
sleep apnoea breathing therapy ME equipment, which are given in ISO 80601-2-70 ;
bi-level positive airway pressure (bi-level PAP) ME equipment;
continuous positive airway pressure (CPAP) ME equipment;
2 © ISO 2021 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 80601-2-87:2021
ISO 80601-2-87:2021(E)
1
respiratory high-flow ME equipment, which are given in ISO 80601-2-90:— ; and
cuirass or “iron-lung” ventilation equipment.
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO
80601 series.
201.1.2 Object
Replacement:
The object of this document is to establish particular basic safety and essential performance
requirements for a high-frequency ventilator, as defined in 201.3.201, and its accessories.
NOTE 1 Accessories are included because the combination of the high-frequency ventilator and the accessories
needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of
a high-frequency ventilator.
[39] [40]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of
ISO 16142-1:2016 as indicated in Annex DD.
NOTE 4 This document has been prepared to address the relevant general safety and performance requirements
[38]
of European regulation (EU) 2017/745 as indicated in Annex FF.
201.1.3 Collateral standards
Amendment (add after existing text):
This document refers to those applicable collateral standards that are listed in Clause 2 of the
general standard and 201.2 of this document.
IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-8 apply as modified in Clauses 202, 206 and 208
[29] [30] [31]
respectively. IEC 60601-1-3 , IEC 60601-1-9 , IEC 60601-1-11 and IEC 60601-1-12 do
not apply. All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard, including the collateral standards, as appropriate for the
particular ME equipment under consideration, and may add other basic safety or essential
performance requirements.
A requirement of a particular standard takes priority over
IEC 60601-1:2005+AMD1:2012+AMD2:2020 or the collateral standards.
For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this particular
document as the general standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of
1
Under preparation. Stage at the time of publication: ISO/DIS 80601-2-90:2020.
© ISO 2021 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 80601-2-87:2021
ISO 80601-2-87:2021(E)
the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final
digits of the collateral standard document number (e.g. 202.4 in this document addresses the
content of Clause 4 of the IEC 60601-1-2 collateral standard, 208.4 in this document addresses
the content of Clause 4 of the IEC 60601-1-8 collateral standard, etc.). The changes to the text of
the general standard are specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601-1:2005 or the applicable
collateral standard is replaced completely by the text of this document.
“Addition” means that the text of this document is additional to the requirements of IEC 60601-
1:2005 or the applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601-1:2005 or the applicable
collateral standard is amended as indicated by the text of this document.
Subclauses, figures or tables that are additional to those of the general standard are numbered
starting from 201.101. However, due to the fact that definitions in the general standard are
numbered 3.1 through 3.147, additional definitions in this document are numbered beginning
from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting
from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for
[29]
IEC 60601-1-3 , etc.
The term “this document” is used to make reference to the general standard, any applicable
collateral standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of
IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard, although possibly relevant,
is not to be applied, a statement to that effect is given in this particular document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies.
For undated references, the latest edition of the referenced document (including any
amendments) applies.
Clause 2 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:
Replacement:
ISO 7000:2019, Graphical symbols for use on equipment — Registered symbols
ISO 7010:2019, Graphical symbols — Safety colours and safety signs — Registered safety signs
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
Addition:
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise
sources using sound pressure — Engineering methods for an essentially free field over a reflecting
plane
4 © ISO 2021 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 80601-2-87:2021
ISO 80601-2-87:2021(E)
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones
and sockets
ISO 5359:2014+AMD1:2017, Anaesthetic and respiratory equipment – Low-pressure hose
assemblies for use with medical gases
ISO 5367:2014, Anaesthetic and respiratory equipment – Breathing sets and connectors
ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical
gases and vacuum
ISO 14937:2009, Sterilization of health care products — General requirements for
characterization of a sterilizing agent and the development, validation and routine control of a
sterilization process for medical devices
ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of
medical devices — Part 1: General essential principles and additional specific essential principles
for all non-IVD medical devices and guidance on the selection of standards
ISO 17664:2017, Processing of health care products — Information to be provided by the medical
device manufacturer for the processing of medical devices
ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare
applications — Part 1: Evaluation and testing within a risk management process
ISO 20417:2020, Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use: — Part 1: Salt test
method to assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use: — Part 2: Non-
filtration aspects
ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
General requirements
ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the
basic safety and essential performance of respiratory gas mo
...
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-87:2020
01-marec-2020
Medicinska električna oprema - 2-87. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti visokofrekvenčnega ventilatorja (ISO/DIS 80601-2-87:2020)
Medical electrical equipment - Part 2-87: Particular requirements for basic safety and
essential performance of high-frequency ventilators (ISO/DIS 80601-2-87:2020)
Medizinische elektrische Geräte - Teil 2-87: Besondere Festlegungen an die Sicherheit
und die wesentlichen Leistungsmerkmale von Hochfrequenzbeatmungsgeräten (ISO/DIS
80601-2-87:2020)
Appareils électromédicaux - Partie 2-87: Titre manque (ISO/DIS 80601-2-87:2020)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-87
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-87:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 80601-2-87:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 80601-2-87:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 80601-2-87
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-01-17 2020-04-10
Medical electrical equipment —
Part 2-87:
Particular requirements for basic safety and essential
performance of high-frequency ventilators
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
This draft is submitted to a parallel vote in ISO and in IEC.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 80601-2-87:2020(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 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
1 Contents
2 201.1 Scope, object and related standards . 1
3 201.2 Normative references . 4
4 201.3 Terms and definitions. 7
5 201.4 General requirements . 8
6 201.5 General requirements for testing of ME equipment . 10
7 201.6 Classification of ME equipment and ME systems . 11
8 201.7 ME equipment identification, marking and documents. 11
9 201.8 Protection against electrical hazards from ME equipment . 18
10 201.9 Protection against mechanical hazards of ME equipment and ME systems . 18
11 201.10 Protection against unwanted and excessive radiation hazards . 22
12 201.11 Protection against excessive temperatures and other hazards . 22
13 201.12 Accuracy of controls and instruments and protection against hazardous
14 outputs . 26
15 201.13 Hazardous situations and fault conditions for ME equipment . 40
16 201.14 Programmable electrical medical systems (PEMS) . 42
17 201.15 Construction of ME equipment . 42
18 201.16 ME systems . 45
19 201.17 Electromagnetic compatibility of ME equipment and ME systems . 45
20 201.101 Gas connections . 46
21 201.102 Requirements for the HFV breathing system and accessories . 48
22 201.103 Spontaneous breathing during loss of power supply . 49
23 201.104 Indication of duration of operation . 50
24 201.105 Functional connection . 50
25 201.106 Display loops . 51
26 201.107 Timed high frequency oscillation pause . 51
27 202 Electromagnetic disturbances – Requirements and tests . 51
28 206 Usability . 52
29 208 General requirements, tests and guidance for alarm systems in medical
30 electrical equipment and medical electrical systems . 54
31 Annexes . 57
32 Annex C (informative) Guide to marking and labelling requirements for
33 ME equipment and ME systems . 58
34 Annex D (informative) Symbols on marking . 63
35 Annex AA (informative) Particular guidance and rationale. 66
36 Annex BB (informative) Data interface requirements . 97
37 Annex CC (informative) Reference to the essential principles . 103
38 Annex DD (informative) Reference to the general safety and performance
39 requirements . 106
40 Annex EE (informative) Terminology — alphabetized index of defined terms . 109
© ISO/IEC 2020 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
41 Bibliography . 114
42
43 Figures
44 Figure 201.101 — Typical closed suctioning test setup . 21
45 Figure 201.102 — Performance test setup for an HFV with
46 a patient-connection port . 28
47 Figure 201.103 —Performance test setup for an HFV without
48 a patient-connection port . 29
49 Figure AA.1 — Representative Pressure waveform in an HFV . 67
50 Figure AA.2 — Breathing system leakage flowrate limits as a function of pressure
[1] [3]
51 as specified in ISO 80601-2-12 and ISO 80601-2-13 . 93
52
53 Tables
54 Table 201.101 — Distributed essential performance requirements . 8
55 Table 201.102 — Test conditions for acoustic tests . 19
56 Table 201.103 — Examples of permissible combinations of temperature and
57 relative humidity . 22
58 Table 201.104 — Test conditions for mean airway pressure and other tests . 30
59 Table 201.105 — Tracheal tube parameters for HFV performance tests . 30
60 Table 201.C.101 — Marking on the outside of a ventilator, its parts or accessories . 58
61 Table 201.C.102 — Accompanying documents, general . 59
62 Table 201.C.103 — Instructions for use . 59
63 Table 201.C.104 — Technical description . 62
64 Table 201.D.2.101 — Additional symbols on marking . 63
65 Table AA.1 — Calculated conductance values by patient weight range . 92
66 Table BB.101 — Parameters and units of measurement . 98
67 Table BB.102 — Equipment identification . 99
68 Table BB.103 — Usage monitoring . 99
69 Table BB.104 — Equipment settings . 99
70 Table BB.105 — Ventilation monitoring . 100
71 Table BB.106 — Ventilator alarm limits . 101
72 Table BB.107 — Event information . 101
73 Table BB.108 — Service monitoring . 102
74 Table CC.1 — Correspondence between this document and the essential principles . 103
75 Table DD.1 — Correspondence between this document and the general safety and
76 performance requirements . 106
77
iv © ISO/IEC 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
78 Foreword
79 ISO (the International Organization for Standardization) is a worldwide federation of
80 national standards bodies (ISO member bodies). The work of preparing International
81 Standards is normally carried out through ISO technical committees. Each membe r body
82 interested in a subject for which a technical committee has been established has the right
83 to be represented on that committee. International organizations, governmental and non -
84 governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with
85 the International Electrotechnical Commission (IEC) on all matters of electrotechnical
86 standardization.
87 The procedures used to develop this document and those intended for its further
88 maintenance are described in the ISO/IEC Directives, Part 1. In particular the different
89 approval criteria needed for the different types of ISO documents should be noted. This
90 document was drafted in accordance with the editorial rules of the ISO/IEC Directives,
91 Part 2. www.iso.org/directives
92 Attention is drawn to the possibility that some of the elements of this document may be
93 the subject of patent rights. ISO shall not be held responsible for identifying any or all such
94 patent rights. Details of any patent rights identified during the development of the
95 document will be in the Introduction and/or on the ISO list of patent declarations received.
96 www.iso.org/patents
97 Any trade name used in this document is information given for the convenience of users
98 and does not constitute an endorsement.
99 This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and
100 respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment and
101 Technical Committee IEC/TC62, Electrical equipment in medical practice, Subcommittee
102 62D: Electric equipment.
103 This is the first edition of ISO 80601-2-87.
104 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
105
© ISO/IEC 2020 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
106 Introduction
107 In this document, the following print types are used:
108 – Requirements and definitions: roman type
109 – Instructions, test specifications and terms defined in Clause 3 of the general standard, in
110 this document or as noted: italic type
111 – Informative material appearing outside of tables, such as notes, examples and references: in
112 smaller type. Normative text of tables is also in a smaller type
113 In referring to the structure of this document, the term
114 – “clause” means one of the four numbered divisions within the table of contents,
115 inclusive of all subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.);
116 – “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are
117 all subclauses of Clause 201).
118 References to clauses within this document are preceded by the term “Clause” followed by
119 the clause number. References to subclauses within this document are by number only.
120 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if
121 any combination of the conditions is true.
122 The verbal forms used in this document conform to usage described in ISO/IEC Directives,
123 Part 2. For the purposes of this document, the auxiliary verb:
124 – “shall” means that conformance with a requirement or a test is mandatory for
125 conformance with this document;
126 – “should” means that conformance with a requirement or a test is recommended but is
127 not mandatory for conformance with this document;
128 – “may” is used to describe permission (e.g. a permissible way to achieve conformance
129 with a requirement or test);
130 – "can" is used to describe a possibility or capability; and
131 – "must" is used to express an external constraint.
132 Annex C contains a guide to the marking and labelling requirements in this document.
133 Annex D contains a summary of the symbols referenced in this document.
134 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table
135 title indicates that there is guidance or rationale related to that item in Annex AA.
vi © ISO/IEC 2020 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
136 Medical Electrical Equipment — Part 2-87: Particular
137 requirements for basic safety and essential performance
138 of high-frequency critical care ventilators
139 201.1 Scope, object and related standards
1
140 Clause 1 of the general standard applies, except as follows:
141 201.1.1 * Scope
142 Replacement:
143 This document applies to the basic safety and essential performance of a high-frequency
144 ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:
145 ⎯ intended for use in an environment that provides specialized care for patients whose
146 conditions can be life-threatening and who can require comprehensive care and
147 constant monitoring in a professional healthcare facility;
148 NOTE 1 For the purposes of this document, such an environment is referred to as a critical care
149 environment. High-frequency ventilators for this environment are considered life-sustaining.
150 NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport
151 within a professional healthcare facility (i.e. be a transit-operable ventilator).
152 NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare
153 facility is not considered as an ventilator intended for the emergency medical services environment.
154 ⎯ intended to be operated by a healthcare professional operator;
155 ⎯ intended for those patients who need differing levels of support from artificial
156 ventilation including ventilator-dependent patients; and
157 ⎯ capable of providing more than 150 inflations/min.
158 There are three principal designations of HFV:
159 ⎯ high frequency percussive ventilation (HFPV, with a typical HFV frequency of (60 to
160 1 000) HFV inflations/min);
161 ⎯ high frequency jet ventilation (HFJV, with a typical HFV frequency of (100 to 1 500)
162 HFV inflations/min); and
163 ⎯ high frequency oscillatory ventilation (HFOV, with a typical HFV frequency of (180 to
164 1200) HFV inflations/min and typically having an active expiratory phase).
165 Additionally, HFV designations can be combined together or with ventilation at rates less
166 than 150 inflations/min.
1
The general standard is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
© ISO/IEC 2020 – All rights reserved 1
---------------------- Page: 9 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
167 * A high-frequency ventilator is not considered to utilize physiologic closed loop-control
168 system unless it uses a physiological patient variable to adjust the ventilation therapy
169 settings.
170 This document is also applicable to those accessories intended by their manufacturer to be
171 connected to an HFV breathing system, or to a high-frequency ventilator, where the
172 characteristics of those accessories can affect the basic safety or essential performance of
173 the high-frequency ventilator.
174 If a clause or subclause is specifically intended to be applicable to ME equipment only, or
175 to ME systems only, the title and content of that clause or subclause will say so. If that is
176 not the case, the clause or subclause applies both to ME equipment and to ME systems, as
177 relevant.
178 Hazards inherent in the intended physiological function of ME equipment or ME systems
179 within the scope of this document are not covered by specific requirements in this
180 document except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.
181 NOTE 4 Additional information can be found in 4.2 of IEC 60601-1:2005+AMD1:2012.
182 This document is not applicable to ME equipment that is intended solely to augment the
183 ventilation of spontaneously breathing patients within a professional healthcare facility.
184 This document does not specify the requirements for:
185 ⎯ non-high-frequency ventilators or accessories which provide conventional ventilation
186 for use in critical care environments, which are given in ISO 80601-2-12;.
187 NOTE 5 An HFV can incorporate conventional critical care ventilator operational modes, in which case
188 ISO 80601-2-12 is applicable to those modes.
189 ⎯ ventilators or accessories intended for anaesthetic applications, which are given in
2
[3]
190 ISO 80601-2-13 ;
191 ⎯ ventilators or accessories intended for the emergency medical services environment,
[4]
192 which are given in ISO 80601-2-84, the future replacement for ISO 10651-3 ;
193 NOTE 6 An HFV can incorporate EMS ventilator capability.
194 ⎯ ventilators or accessories intended for ventilator-dependent patients in the home
[5]
195 healthcare environment, which are given in ISO 80601-2-72 ;
196 ⎯ ventilators or accessories intended for home-care ventilatory support devices, which
[6] [7]
197 are given in ISO 80601-2-79 and ISO 80601-2-80 , the replacements for
[8]
198 ISO 10651-6 ;
[9]
199 ⎯ sleep apnoea breathing therapy ME equipment, which are given in ISO 80601-2-70 ;
200 ⎯ continuous positive airway pressure (CPAP) ME equipment;
201 ⎯ oxygen therapy constant flow ME equipment; and
2
Figures in square brackets refer to the Bibliography.
2 © ISO/IEC 2020 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
202 ⎯ cuirass or “iron-lung” ventilation equipment.
203 This document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of
204 documents.
205 201.1.2 Object
206 Replacement:
207 The object of this document is to establish particular basic safety and essential performance
208 requirements for a high-frequency ventilator, as defined in 201.3.201, and its accessories.
209 NOTE 1 Accessories are included because the combination of the high-frequency ventilator and the
210 accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or
211 essential performance of a high-frequency ventilator.
212 NOTE 2 This document has been prepared to address the relevant essential principles of safety and
213 performance of ISO 16142-1:2016 as indicated in Annex CC.
214 NOTE 3 This document has been prepared to address the relevant general safety and performance
[10]
215 requirements of European regulation (EU) 2017/745 as indicated in Annex DD.
216 201.1.3 Collateral standards
217 Amendment (add after existing text):
218 This document refers to those applicable collateral standards that are listed in Clause 2 of
219 the general standard and 201.2 of this document.
220 IEC 60601-1-2, IEC 60601-1-6 and IEC 60601-1-8 apply as modified in Clauses 202, 206
[11] [12]
221 and 208 respectively. IEC 60601-1-3 , IEC 60601-1-9 , IEC 60601-1-11 and
[13]
222 IEC 60601-1-12 do not apply. All other published collateral standards in the
223 IEC 60601-1 series apply as published.
224 201.1.4 Particular standards
225 Replacement:
226 In the IEC 60601 series, particular standards may modify, replace or delete requirements
227 contained in the general standard, including the collateral standards, as appropriate for
228 the particular ME equipment under consideration, and may add other basic safety or
229 essential performance requirements.
230 A requirement of a particular standard takes priority over IEC 60601-1:2005 or the
231 collateral standards.
232 For brevity, IEC 60601-1:2005+AMD1:2012 is referred to in this particular document as
233 the general standard. Collateral standards are referred to by their document number.
234 The numbering of clauses and subclauses of this document corresponds to those of the
235 general standard with the prefix “201” (e.g. 201.1 in this document addresses the content
236 of Clause 1 of the general standard) or applicable collateral standard with the prefix “2xx”
237 where xx is the final digits of the collateral standard document number (e.g. 202.4 in this
238 document addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard,
239 208.4 in this document addresses the content of Clause 4 of the IEC 60601-1-8 collateral
240 standard, etc.). The changes to the text of the general standard are specified by the use of
241 the following words:
© ISO/IEC 2020 – All rights reserved 3
---------------------- Page: 11 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
242 “Replacement” means that the clause or subclause of IEC 60601-1:2005 or the applicable
243 collateral standard is replaced completely by the text of this document.
244 “Addition” means that the text of this document is additional to the requirements of
245 IEC 60601-1:2005 or the applicable collateral standard.
246 “Amendment” means that the clause or subclause of IEC 60601-1:2005 or the applicable
247 collateral standard is amended as indicated by the text of this document.
248 Subclauses, figures or tables that are additional to those of the general standard are
249 numbered starting from 201.101. However, due to the fact that definitions in the general
250 standard are numbered 3.1 through 3.147, additional definitions in this document are
251 numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
252 additional items aa), bb), etc.
253 Subclauses or figures that are additional to those of a collateral standard are numbered
254 starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
[11]
255 IEC 60601-1-2, 203 for IEC 60601-1-3 , etc.
256 The term “this document” is used to make reference to the general standard, any
257 applicable collateral standards and this particular document taken together.
258 Where there is no corresponding clause or subclause in this document, the clause or
259 subclause of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard,
260 although possibly not relevant, applies without modification; where it is intended that any
261 part of IEC 60601-1:2005+AMD1:2012 or the applicable collateral standard, although
262 possibly relevant, is not to be applied, a statement to that effect is given in this particular
263 document.
264 201.2 Normative references
265 The following documents are referred to in the text in such a way that some or all of their
266 content constitutes requirements of this document. For dated references, only the edition
267 cited applies. For undated references, the latest edition of the referenced document
268 (including any amendments) applies.
269 NOTE 1 The way in which these referenced documents are cited in normative requirements determines
270 the extent (in whole or in part) to which they apply.
271 NOTE 2 Informative references are listed in the Bibliography.
272 Clause 2 of the general standard applies, except as follows:
273 Replacement:
274 ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols
275 ISO 7010:2011+AMD1:2012+AMD2:2012+AMD3:2012+AMD4:2013+AMD5:2014
276 +AMD6:2014+AMD7:2016+AMD8:2017, Graphical symbols — Safety colours and safety
277 signs — Registered safety signs
278 ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels,
279 labelling and information to be supplied — Part 1: General requirements
280 IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for
281 basic safety and essential performance — Collateral standard: Electromagnetic
282 disturbances — Requirements and tests
4 © ISO/IEC 2020 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 80601-2-87:2020
ISO/DIS 80601-2-87:2020(E)
283 IEC 60601-1-6:2010+AMD1:2013, Medical electrical equipment — Part 1-6: General
284 requirements for basic safety and essential performance — Collateral standard: Usability
285 IEC 60601-1-8:2006+AMD1:2012, Medical electrical equipment — Part 1-8: General
286 requirements for basic safety and essential performance — Collateral standard: General
287 requirements, tests and guidance for alarm systems in medical electrical equ ipment and
288 medical electrical systems
289 IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
290 IEC 62304:2006+AMD1:2015, Medical device software — Software life cycle processes
291 Addition:
292 ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
293 ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels
294 of noise sources using sound pressure — Engineering methods for an essentially free field
295 over a reflecting plane
296 ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of
297 machinery and equipment
298 ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1:
299 Cones and sockets
300 ISO 5359:2014, Anaesthetic and respiratory equipment -- Low-pressure hose assemblies for
301 use with medical gases
302 ISO 5367:2014, Anaesthetic and respiratory equipment -- Breathing sets and connecto
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.