SIST EN 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

• Status: Published
• Public Enquiry End Date: 19-Mar-2020
• Publication Date: 03-Jun-2021
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-May-2021
• Due Date: 18-Jul-2021
• Completion Date: 04-Jun-2021
• Ref Project: EN 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)

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.

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SIST EN ISO 80601-2-87:2021
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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.
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SIST EN ISO 80601-2-87:2021
EN ISO 80601-2-87:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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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.
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SIST EN ISO 80601-2-87:2021
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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
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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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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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
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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
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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
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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
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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
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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
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SIST EN ISO 80601-2-87:2021
ISO 80601-2-87:2021(E)
 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

Under preparation. Stage at the time of publication: ISO/DIS 80601-2-90:2020.
© ISO 2021 – All rights reserved 3
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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
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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.

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oSIST prEN ISO 80601-2-87:2020
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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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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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

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41 Bibliography ......................................................................................................................................... 114

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

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

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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
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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.

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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
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.

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
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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

[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
Figures in square brackets refer to the Bibliography.
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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:
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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
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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

...