EN ISO 80601-2-80:2019

Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories:
—          intended for use in the home healthcare environment;
—          intended for use by a lay operator;
—          intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
—          intended for transit-operable use;
—          not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1    Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.
NOTE 1    In the home healthcare environment, the supply mains is often not reliable.
NOTE 2    Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2    Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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 IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 3    Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for:
—          ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
—          ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[5];
—          ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[6][1], the future replacement for ISO 10651‑3[7];
—          ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—          ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79[1];
—          sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[8];
—          continuous positive airway pressure (CPAP) me equipment;
—          high-frequency jet ventilators (HFJVs);
—          high-frequency oscillatory ventilators (HFOVs)[9];
—          oxygen therapy constant flow me equipment;
—          cuirass or "iron-lung" ventilation equipment.
This document is a particular standard in the IEC 60601 and IEC

Medizinische elektrische Geräte - Teil 2-80: Besondere Festlegungen für die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten zur Atemunterstützung von Patienten mit Atmungsinsuffizienz (ISO 80601-2-80:2018)

Dieses Dokument gilt für die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE eines HEIMBEATMUNGSGERÄTS ZUR ATEMUNTERSTÜTZUNG nach 201.3.205 für PATIENTEN mit ATMUNGSINSUFFIZIENZ nach 201.3.204 in Kombination mit dessen ZUBEHÖR, nachfolgend auch als ME-GERÄT bezeichnet, das
   für die Anwendung in der MEDIZINISCHEN VERSORGUNG IN HÄUSLICHER UMGEBUNG vorgesehen ist,
   für die Anwendung durch einen NICHT FACHKUNDIGEN BEDIENER vorgesehen ist,
   für PATIENTEN mit ATMUNGSINSUFFIZIENZ vorgesehen ist, wobei die fragilsten von ihnen bei Verlust dieser künstlichen Beatmung wahrscheinlich gesundheitliche Schäden erleiden würden,
   für den Einsatz als BEI BEWEGUNG BETRIEBSFÄHIGES Gerät vorgesehen ist,

Appareils électromédicaux - Partie 2-80: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'assistance ventilatoire en cas d'insuffisance ventilatoire (ISO 80601-2-80:2018)

Le présent document s'applique à la sécurité de base et aux performances essentielles des équipements d'assistance ventilatoire, tels que définis en 201.3.205, pour les insuffisances ventilatoires, telles que définies en 201.3.204, ci-après également désignés par appareils em, en association avec leurs accessoires:
—          destinés à être utilisés dans l'environnement des soins à domicile;
—          destinés à être utilisés par un opérateur non spécialiste;
—          destinés à être utilisés avec des patients souffrant d'une insuffisance ventilatoire ou d'un trouble ventilatoire, les plus fragiles de ces patients ayant des risques d'être blessés en cas de perte de cette ventilation artificielle;
—          destinés à être opérationnel en déplacement;
—          non destinés à être utilisés chez les patients dont le maintien immédiat des fonctions vitales dépend d'une ventilation artificielle.
EXEMPLE 1    Patients souffrant d'une bronchopneumopathie chronique obstructive (BPCO) modérée à grave, d'une sclérose latérale amyotrophique (SLA) modérée, d'une dysplasie bronchopulmonaire grave ou d'une dystrophie musculaire.
NOTE 1    Dans l'environnement des soins à domicile, il est fréquent que le réseau d'alimentation ne soit pas fiable.
NOTE 2    Ces équipements d'assistance ventilatoire peuvent également être utilisés dans les établissements de santé professionnels, pour d'autres applications qu'en soins intensifs.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être raccordés au système respiratoire du ventilateur des équipements d'assistance ventilatoire en cas d'insuffisance ventilatoire, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles des équipements d'assistance ventilatoire en cas d'insuffisance ventilatoire.
EXEMPLE 2    Ensembles respiratoires, raccords, pièges à eau, valve expiratoire, humidificateur, filtre pour système respiratoire, source d'énergie électrique externe et système d'alarme réparti.
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. Dans le cas contraire, 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 de l'IEC 60601‑1:2005+AMD1:2012, 7.2.13 et 8.4.1.
NOTE 3    Des informations supplémentaires peuvent être trouvées dans l'IEC 60601‑1:2005+AMD1:2012, 4.2.
Le présent document ne spécifie pas les exigences relatives aux:
—          ventilateurs ou accessoires pour patients ventilo-dépendants prévus pour les applications en soins intensifs, qui sont données dans l'ISO 80601‑2‑12;
—          ventilateurs ou accessoires prévus pour les applications en anesthésie, qui sont données dans l'ISO 80601‑2‑13[5];
—          ventilateurs ou accessoires destinés à l'environnement des services médicaux d'urgence, qui sont données dans l'ISO 80601‑2‑84[6][1]), qui remplacera l'ISO 10651‑3[7];
      ventilateurs ou accessoires pour patients ventilo-dépendants dans l'environnement des soins à domicile, qui sont données dans l'ISO 80601‑2‑72;
—          équipements d'ass

Medicinska električna oprema - 2-80. del: Posebne zahteve za osnovno varnost in bistvene lastnosti pomožne ventilacijske opreme pri nezadostnem prezračevanju (ISO 80601-2-80:2018)

Ta dokument se uporablja za osnovno varnost in bistvene lastnosti pomožne ventilacijske opreme, kot je opredeljeno v točki 201.3.205, pri nezadostnem prezračevanju, kot je določeno v točki 201.3.204, v nadaljevanju poimenovane tudi elektromedicinska oprema, in sicer skupaj z dodatno opremo:
– ki je namenjena za uporabo v okolju domače zdravstvene oskrbe;
– ki je namenjena nestrokovnjakom;
– ki je namenjena za uporabo pri bolnikih z nezadostnim prezračevanjem ali okvaro ventilatorja, pri čemer bo pri bolnikih najšibkejšega zdravja verjetno prišlo do telesnih poškodb zaradi izgube te umetne ventilacije;
– ki je namenjena za delovanje med nošnjo;
– ki ni namenjena bolnikom, ki so odvisni od umetne ventilacije za neposredno ohranjanje pri življenju.
PRIMER 1: Bolniki z blago ali zmerno kronično obstruktivno pljučno boleznijo (COPD), zmerno amiotrofično lateralno sklerozo (ALS), hudo bronhopulmonalno displazijo ali mišično distrofijo.
OPOMBA 1: V okolju domače zdravstvene oskrbe napajalno omrežje pogosto ni zanesljivo.
OPOMBA 2: Taka pomožna ventilacijska oprema se lahko uporablja tudi pri nekritični oskrbi v zdravstvenih ustanovah.
Ta dokument se uporablja tudi za tisto dodatno opremo, ki jo je proizvajalec predvidel za priklop na ventilatorski dihalni sistem pomožne ventilacijske opreme pri nezadostnem prezračevanju, pri čemer lahko lastnosti te dodatne opreme vplivajo na osnovno varnost ali bistvene lastnosti pomožne ventilacijske opreme pri nezadostnem prezračevanju.
PRIMER 2: Dihalni seti, priključki, sifoni, ventil za izdihavanje, vlažilnik, filter dihalnega sistema, zunanji vir električne energije, distribuiran alarmni sistem.
Če je točka ali podtočka namenjena samo obravnavi elektromedicinske opreme ali elektromedicinskih sistemov, bo to zapisano v naslovu in vsebini dane točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava elektromedicinsko opremo in elektromedicinske sisteme.
Posebne zahteve tega dokumenta ne vključujejo inherentnih tveganj pri predvideni fiziološki funkciji elektromedicinske opreme ali elektromedicinskih sistemov, ki sodijo na področje uporabe tega dokumenta, razen v točkah 7.2.13 in 8.4.1 standarda IEC 60601‑1:2005+AMD1:2012.
OPOMBA 3: Dodatne informacije so navedene v točki 4.2 standarda IEC 60601‑1:2005+AMD1:2012.
Ta dokument ne določa zahtev za:
– ventilatorje ali dodatno opremo za od aparata odvisne bolnike za uporabo pri intenzivni negi, ki so podani v standardu ISO 80601‑2‑12;
– ventilatorje ali dodatno opremo za anestezijsko uporabo, ki so podani v standardu ISO 80601‑2‑13[5];
– ventilatorje ali dodatno opremo za uporabo v okolju nujnih zdravstvenih storitev, ki so podani v standardu ISO 80601‑2‑84[6][1], ki bo v prihodnje nadomeščal standard ISO 10651‑3[7];
– ventilatorje ali dodatno opremo za uporabo pri od aparata odvisnih bolnikih v okolju domače zdravstvene oskrbe, ki so podani v standardu ISO 80601‑2‑72;
– pomožno ventilacijsko opremo ali dodatno opremo pri okvari ventilatorja, ki je podana v standardu ISO 80601‑2‑79[1];
– elektromedicinsko opremo za zdravljenje motenj dihanja v spanju, ki je podana v standardu ISO 80601‑2‑70[8];
– elektromedicinsko opremo za vzdrževanje stalnega tlaka v dihalnih poteh (CPAP);
– ventilatorje za visokofrekvenčno pospešeno predihavanje (HFJV);
– ventilatorje za visokofrekvenčno oscilacijsko predihavanje (HFOV)[9];
– elektromedicinsko opremo za kisikovo terapijo s stalnim pretokom;
– opremo za ventilacijo pljuč, t.i. »curiass« ali »železna pljuča«.
Ta dokument je standard iz skupin dokumentov IEC 60601 in IEC/ISO 80601.
[1] V pripravi. Faza v času objave: ISO/DIS 80601-2-84:2017.

General Information

• Status: Withdrawn
• Publication Date: 17-Sep-2019
• Withdrawal Date: 03-Sep-2024
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Ref Project: SIST EN ISO 80601-2-80:2019 - Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)

Relations

• Replaces: EN ISO 10651-6:2009 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
• Effective Date: 30-Oct-2019
• Replaced By: EN ISO 80601-2-80:2024 - Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024)
• Effective Date: 28-Jul-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2019
Medicinska električna oprema - 2-80. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti pomožne ventilacijske opreme pri nezadostnem prezračevanju
(ISO 80601-2-80:2018)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and
essential performance of ventilatory support equipment for ventilatory insufficiency (ISO
80601-2-80:2018)
Medizinische elektrische Geräte - Teil 2-80: Besondere Festlegungen für die
grundlegende Sicherheit und die wesentlichen Leistungsmerkmale von
Heimbeatmungsgeräten zur Atemunterstützung von Patienten mit Atmungsinsuffizienz
(ISO 80601-2-80:2018)
Appareils électromédicaux - Partie 2-80: Exigences particulières pour la sécurité de base
et les performances essentielles des équipements d'assistance ventilatoire en cas
d'insuffisance ventilatoire (ISO 80601-2-80:2018)
Ta slovenski standard je istoveten z: EN ISO 80601-2-80:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 80601-2-80
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2019
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-80: Particular
requirements for basic safety and essential performance of
ventilatory support equipment for ventilatory
insufficiency (ISO 80601-2-80:2018)
Appareils électromédicaux - Partie 2-80: Exigences Medizinische elektrische Geräte - Teil 2-80: Besondere
particulières pour la sécurité de base et les Festlegungen für die grundlegende Sicherheit und die
performances essentielles des équipements wesentlichen Leistungsmerkmale von
d'assistance ventilatoire en cas d'insuffisance Heimbeatmungsgeräten zur Atemunterstützung von
ventilatoire (ISO 80601-2-80:2018) Patienten mit Atmungsinsuffizienz (ISO 80601-2-
80:2018)
This European Standard was approved by CEN on 28 July 2019.

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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-80:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 80601-2-80:2018 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment” of the International Organization for Standardization (ISO) and has been
taken over as EN ISO 80601-2-80:2019 by 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 March 2020, and conflicting national standards shall
be withdrawn at the latest by March 2020.
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 80601-2-80:2018 has been approved by CEN as EN ISO 80601-2-80:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-80
First edition
2018-07
Medical electrical equipment —
Part 2-80:
Particular requirements for basic
safety and essential performance of
ventilatory support equipment for
ventilatory insufficiency
Appareils électromédicaux —
Partie 2-80: Exigences particulières pour la sécurité de base et les
performances essentielles des équipements d'assistance ventilatoire
en cas d'insuffisance ventilatoire
Reference number
ISO 80601-2-80:2018(E)
©
ISO 2018
ISO 80601-2-80:2018(E)
© ISO 2018
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 2018 – All rights reserved

ISO 80601-2-80:2018(E)
Contents
Foreword . vi
Introduction . viii
201.1 Scope, object and related standards . 1
201.1.1 * Scope . 1
201.1.2 Object . 2
201.1.3 Collateral standards . 2
201.1.4 Particular standards . 3
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 7
201.4.3 Essential performance . 7
201.4.3.101 * Additional requirements for ESSENTIAL PERFORMANCE . 7
201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 7
201.4.11.101 * Additional requirements for pressurized gas input . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.5.101 * Additional requirements for the general requirements for testing of
ME EQUIPMENT . 9
201.5.101.1 Ventilatory support equipment test conditio ns . 9
201.5.101.2 * Gas flowrate and leakage specifications . 9
201.5.101.3 * VENTILATORY SUPPORT EQUIPMENT testing errors . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.6.101 * Additional requirements for classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 17
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.11.7 Biocompatiblity of ME EQUIPMENT and ME SYSTEMS . 20
201.11.8 Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT . 21
201.11.8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT ALARM CONDITION . 21
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 23
201.12.1 Accuracy of controls and instruments . 23
201.12.1.101 Volume-controlled breath type . 23
201.12.1.102 Pressure-controlled breath type . 26
201.12.1.103 Other breath types . 28
201.12.2.101 Usability of me equipment . 29
201.12.4 Protection against hazardous output . 29
201.12.4.101 * Measurement of AIRWAY PRESSURE . 29
201.12.4.102 Measurement of expired volume . 31
201.12.4.103 * Maximum limited pressure protection device . 31
201.12.4.104 Hypoventilation ALARM CONDITION . 31
201.12.4.105 * High leakage ALARM CONDITION . 31
201.12.4.106 * CO rebreathing . 32
201.12.101 * Protection against accidental adjustments . 32
© ISO 2018 – All rights reserved iii

ISO 80601-2-80:2018(E)
201.13 Hazardous situations and fault conditions for ME EQUIPMENT. 33
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 34
201.15 Construction of ME EQUIPMENT . 34
201.15.101 Mode of operation . 34
201.15.102 Pre-use check . 34
201.16 ME SYSTEMS . 34
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 35
201.101 Gas connections . 35
201.101.1 VBS connec
...