EN ISO 80601-2-12:2011

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)

ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:
intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and
intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility.
ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation.
ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation.
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.
ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13.
ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2.
ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3.
ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6.

Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die Intensivpflege (ISO 80601-2-12:2011)

Appareils électromédicaux - Partie 2-12: Exigences particulières relatives à la sécurité de base et aux performances essentielles des ventilateurs pulmonaires pour utilisation en soins intensifs (ISO 80601-2-12:2011)

L'ISO 80601-2-12:2010 s'applique à la sécurité de base et aux performances essentielles d'un ventilateur associé à ses accessoires, ci-après désignés par appareil em:
destinés à être utilisés par un opérateur professionnel sur des patients dépendants d'une ventilation mécanique; et
destinés à être utilisés dans un environnement de soins intensifs, dans un établissement de santé professionnel ou lors d'un transport dans un établissement de soins professionnel.
L'ISO 80601-2-12:2010 s'applique également aux accessoires conçus par leur fabricant pour être connectés à un système respiratoire ou un ventilateur, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base et les performances essentielles du ventilateur.
L'ISO 80601-2-12:2010 n'est applicable à aucun appareil em ni système em fournissant des modes de ventilation pour patients non dépendants de la ventilation mécanique.
L'ISO 80601-2-12:2010 n'est applicable à aucun appareil em ni système em pour patient non dépendant de la ventilation mécanique.
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 aux appareils em et aux systèmes em, selon le cas.
L'ISO 80601-2-12:2010 ne s'applique pas aux appareils em délivrant une pression positive continue (CPAP), aux appareils em de thérapie d'apnée du sommeil, aux ventilateurs de soins de santé à domicile, aux appareils em d'assistance respiratoire, aux ventilateurs de secours et de transport, aux ventilateurs d'anesthésie, aux jets ventilateurs à haute-fréquence (JVHF) et aux ventilateurs à oscillation haute-fréquence (VOHF). L'ISO 80601‑2‑12:2010 ne précise pas les exigences liées aux appareils em uniquement destinés à augmenter la ventilation des patients respirant spontanément au sein d'un établissement de santé professionnel.
L'ISO 80601-2-12:2010 ne précise pas les exigences liées aux ventilateurs ou accessoires prévus pour des applications anesthésiques. Celles-ci sont données dans l'ISO 80601-2-13.
L'ISO 80601-2-12:2010 ne précise pas les exigences liées aux ventilateurs ou accessoires destinés aux ventilateurs pour soins à domicile pour patients dépendants d'un ventilateur. Celles-ci sont données dans l'ISO 10651-2.
L'ISO 80601-2-12:2010 ne précise pas les exigences liées aux ventilateurs ou accessoires prévus pour les urgences et le transport. Celles-ci sont données dans l'ISO 10651-3.
L'ISO 80601-2-12:2010 ne précise pas les exigences liées aux ventilateurs ou accessoires prévus pour les dispositifs d'assistance respiratoire à domicile. Celles-ci sont données dans l'ISO 10651-6.

Elektromedicinska oprema - 2-12. del: Posebne zahteve za osnovno varnost in bistvene lastnosti ventilatorjev za intenzivno nego (ISO 80601-2-12:2011)

IEC 60601-1:2005, točka 1 velja, razen: Podtočka 1.1. 60601-1:2005, točka 1 je nadomeščena z naslednjim. Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI VENTILATORJEV skupaj z DODATKI, v nadaljevanju OPREMA ME: - namenjeno, da jo spremlja strokovni OPERATER pri tistih BOLNIKIH, ki so odvisni od mehanske ventilacije; in OPOMBA 1: Taki VENTILATORJI se štejejo za OPREMO ME ALI SISTEME ME, KI VZDRŽUJEJO TELESNE FUNKCIJE. - namenjeno za uporabo v okoljih za kritično nego v strokovni zdravstveni ustanovi ali namenjeno uporabi pri prevozu v strokovni zdravstveni ustanovi.

General Information

• Status: Withdrawn
• Publication Date: 14-Apr-2011
• Withdrawal Date: 10-Mar-2020
• 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
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 11-Mar-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 80601-2-12:2011 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2011)

Relations

• Replaces: EN 794-1:1997+A2:2009 - Lung ventilators - Part 1: Particular requirements for critical care ventilators
• Effective Date: 23-Apr-2011
• Replaced By: EN ISO 80601-2-12:2020 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)
• Effective Date: 24-Mar-2020
• Corrected By: EN ISO 80601-2-12:2011/AC:2011 - Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators - Technical Corrigendum 1 (ISO 80601-2-12:2011/Cor 1:2011)
• Effective Date: 08-Jun-2022
• Revised: EN 794-1:1997 - Lung ventilators - Part 1: Particular requirements for critical care ventilators
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2011
1DGRPHãþD
SIST EN 794-1:2000+A2:2009
Elektromedicinska oprema - 2-12. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti ventilatorjev za intenzivno nego (ISO 80601-2-12:2011)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and
essential performance of critical care ventilators (ISO 80601-2-12:2011)
Medizinische elektrische Geräte - Teil 2-12: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Beatmungsgeräten für die
Intensivpflege (ISO 80601-2-12:2011)
Appareils électromédicaux - Partie 2-12: Exigences particulières de sécurité de base et
de performances essentielles des ventilateurs de soins critiques (ISO 80601-2-12:2011)
Ta slovenski standard je istoveten z: EN ISO 80601-2-12:2011
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.

EUROPEAN STANDARD
EN ISO 80601-2-12
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2011
ICS 11.040.10 Supersedes EN 794-1:1997+A2:2009
English Version
Medical electrical equipment - Part 2-12: Particular requirements
for basic safety and essential performance of critical care
ventilators (ISO/IEC 80601-2-12:2011)
Appareils électromédicaux - Partie 2-12: Exigences Medizinische elektrische Geräte - Teil 2-12: Besondere
particulières relatives à la sécurité de base et aux Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs pulmonaires wesentlichen Leistungsmerkmale von Beatmungsgeräten
pour utilisation en soins intensifs (ISO/IEC 80601-2- für die Intensivpflege (ISO/IEC 80601-2-12:2011)
12:2011)
This European Standard was approved by CEN on 5 February 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-12:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 80601-2-12:2011) 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 2011, and conflicting national standards shall be withdrawn at
the latest by October 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 794-1:1997+A2:2009, EN 60601-2-12:2006.
This first edition of ISO 80601-2-12 cancels and replaces the second edition of IEC 60601-2-12 (2001). This
edition of ISO 80601-2-12 constitutes a major technical revision of IEC 60601-2-12:2001 and includes an
alignment with third edition of IEC 60601-1.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO/IEC 80601-2-12:2011 has been approved by CEN as a EN ISO 80601-2-12:2011 without any
modification.
Annex ZA
(informative)
Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC
This Document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices” (Medical Device Directive).
Once this document is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause/subclause of this Document Corresponding essential Qualifying remarks/notes
requirement of Directive 93/42/EEC
All 1, 2, 3
201.4 1
201.7 5, 8.6, 8.7, 10.3, 11.4.1,12.7.4, 12.8.2, 12.9,
13.1, 13.2, 13.3, 13.4, 13.5, 13.6
201.7.2.3 13.1, 13.2
201.7.2.101 a) 13.3 i)
201.7.2.101 b) 13.3 j), 13.3 k)
201.7.2.101 c), 201.7.2.101 d) 13.1
201.7.2.101 e) 13.3 j), 13.3 k)
201.7.2.101 f) 13.3 e)
201.7.2.101 g) 13.3 k)
201.7.2.101 h) 13.3 k)
201.7.2.4.101 13.1, 13.3 e), 13.3 i), 13.3 j), 13.3 k)
201.7.2.13.101 13.1, 13.2, 13.3 k)
201.7.2.17.101 a) 13.2, 13.3 b), 13.3 c), 13.3 d), 13.3 f), 13.5
201.7.2.17.101 b) 13.2, 13.3 b), 13.3 d), 13.5
201.7.9.1 13.3 a)
201.7.9.2.8.101 13.6 d)
201.7.9.2.9.101 13.6 b)
201.7.9.2.1 a) 13.6 h), 13.6 i)
201.7.9.2.1 b) 13.6 q)
201.7.9.2.2.101 13.1, 13.6 a)
Table ZA.1 — (continued)
Clause/subclause of this Document Corresponding essential Qualifying remarks/notes
requirement of Directive 93/42/EEC
201.7.9.2.9.101 13.6 a), 13.6 b), 13.6 c), 13.6 d)
201.7.9.2.12 13.6 h), 13.6 i)
201.7.9.2.14.101 13.6 c)
201.8 9.1, 9.2, 9.3, 12.6, 12.7.4
201.9 7.1, 9.1, 9.2, 12.7.1, 12.7.2, 12.7.3
201.10 11.1.1, 11.3
201.11 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 8.5, 9.1, 9.3,
12.7.5
201.11.6.4 7.5
201.11.8 12.2, 12.3
201.12 9.2, 10.1, 10.2, 11.1.1, 11.3, 12.3, 12.4,
12.8.1, 12.8.2, 12.9
201.12.1 3, 4
201.12.4 3, 4, 12.4, 12.8
201.13 1, 2, 4, 7.5, 7.6, 9.3 And via IEC 60601-1-6
201.14 9.1, 12.1, 12.1 a)
201.15 4, 9.1, 9.2, 9.3, 12.6, 12.7.1, 12.7.4, 12.7.5
201.16 9.1, 12.6, 12.7, 13.1
201.17 11.1.1, 12.5
201.101 9.1, 9.2, 12.7.4, 12.8.1
201.102 3, 4, 9.1, 13.6 c)
201.103 2, 6
201.104 12.9
201.105 2, 3, 4
201.106 1, 2, 9.1, 9.2 And via IEC 60601-1-6
201.107 1, 12.9 And via IEC 60601-1-6
201.108 1, 3, 9.1, 9.2 And via IEC 60601-1-6
202 9.2, 11.1.1, 12.5
206 1, 9.2, 12.9 And via IEC 60601-1-6
208 12.4
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International Standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant
essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific
than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table
ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not
provide presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on machinery that are
addressed by this Document
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this EN EHSR of 2006/42/EC Qualifying remarks/Notes
201.12.1 1.1.4 And via IEC 60601-1
– 1.1.8
201.12.1, 201.12.101 1.2.2 And via IEC 60601-1 and
IEC 60601-1-6
201.7.2.101 c), 201.7.2.101 d), 201.101.2, 1.5.4
201.101.3, 201.101.4
– 1.6.1 Via IEC 60601-1
– 1.6.2 Via IEC 60601-1
– 1.6.3 Via IEC 60601-1
– 3.4.5 Via IEC 60601-1
201.7.2.101 i) 3.6.2 And via IEC 60601-1

INTERNATIONAL ISO
STANDARD 80601-2-12
First edition
2011-04-15
Medical electrical equipment —
Part 2-12:
Particular requirements for basic safety
and essential performance of critical care
ventilators
Appareils électromédicaux —
Partie 2-12: Exigences particulières relatives à la sécurité de base et
aux performances essentielles des ventilateurs pulmonaires pour
utilisation en soins intensifs

Reference number
ISO 80601-2-12:2011(E)
©
ISO 2011
ISO 80601-2-12:2011(E)
©  ISO 2011
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ISO 80601-2-12:2011(E)
Contents Page
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 . 2
201.2 Normative references . 3
201.3 Terms and definitions . 6
201.4 General requirements . 9
201.4. 3 ESSENTIAL PERFORMANCE . 9
201.4. 3.101 * Additional requirements for ESSENTIAL PERFORMANCE . 9
201.4. 6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 9
201.4. 11.101 * Additional requirements for pressurized gas input . 9
201.4. 11.101.1 Overpressure requirement . 9
201.4. 11.101.2 Compatibility requirement . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.5. 101 * Additional requirements for general requirements for testing of ME EQUIPMENT . 10
201.5. 101.1 VENTILATOR test conditions . 10
201.5. 101.2 * Gas flowrate and leakage
...