EN ISO 80601-2-12:2011

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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved

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 specifications . 11
201.5. 101.3 * VENTILATOR testing errors . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.7. 2.3 * Consult ACCOMPANYING DOCUMENTS . 11
201.7. 2.101 Additional requirements for marking on the outside of ME EQUIPMENT or ME EQUIPMENT
parts . 11
201.7. 2.4.101 Additional requirements for ACCESSORIES . 12
201.7. 2.13.101 Additional requirements for physiological effects . 12
201.7. 2.17.101 Additional requirements for protective packaging . 13
201.7. 4.3 * Unit of measure . 13
201.7. 9.1 Additional general requirements . 13
201.7. 9.2.1.101 Additional general requirements . 14
201.7. 9.2.2.101 * Additional requirements for warnings and safety notices . 14
201.7. 9.2.8.101 * Additional requirements for start-up procedure. 15
201.7. 9.2.9.101 * Additional requirements for operating instructions . 15
201.7. 9.2.12 Cleaning, disinfection, and sterilization . 16
201.7. 9.2.14.101 * Additional requirements for ACCESSORIES, supplementary equipment, used
material . 16
201.7. 9.2.16.101 * Additional requirements for reference to the technical description . 16
201.7. 9.3.1.101 * Additional general requirements . 16
201.7. 9.3.101 Additional requirements for the technical description . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
201.9. 6.2.1.101 Additional requirements for audible acoustic energy . 17
201.9. 101 * Additional requirements for suction procedures . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 20
ISO 80601-2-12:2011(E)
201.11 Protection against excessive temperatures and other HAZARDS .20
201.11. 6.4 Leakage .20
201.11. 6.5.101 * Additional requirements for ingress of water or particulate matter
into ME EQUIPMENT or ME SYSTEM .21
201.11. 6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM .21
201.11. 6.7 Sterilization of ME EQUIPMENT or ME SYSTEM .21
201.11. 8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS
to ME EQUIPMENT .22
201.11. 8.101.1 TECHNICAL ALARM CONDITION for power supply failure .22
201.11. 8.101.2 INTERNAL ELECTRICAL POWER SOURCE or external reserve electrical power source .22
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 * DELIVERED VOLUME MONITORING .29
201.12. 1.104 * Response of the VENTILATOR to an increase in O concentration .29
201.12. 4 Protection against hazardous output .31
201.12. 4.101 Oxygen monitor .31
201.12. 4.102 * Measurement of AIRWAY PRESSURE .31
201.12. 4.103 * Measurement of expired volume and low-volume ALARM CONDITIONS .32
201.12. 4.103.1 VENTILATORS intended to provide a DELIVERED VOLUME > 50 ml .32
201.12. 4.103.2 VENTILATORS intended to provide a DELIVERED VOLUME u 50 ml .32
201.12. 4.104 * MAXIMUM LIMITED PRESSURE PROTECTION DEVICE .33
201.12. 4.105 High-pressure ALARM CONDITION and PROTECTION DEVICE .33
201.12. 4.106 PEEP ALARM CONDITIONS.33
201.12. 4.107 * Obstruction ALARM CONDITION.33
201.12. 4.108 * Partial-occlusion ALARM CONDITION .34
201.12. 101 * Protection against accidental adjustments .34
201.13 HAZARDOUS SITUATIONS and fault conditions .34
201.13. 2.101 * Additional specific SINGLE FAULT CONDITIONS .34
201.13. 102 * Failure of one gas supply to a VENTILATOR .35
201.13. 103 * Independence of ventilation control function and related RISK CONTROL measures .35
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .35
201.14. 101 Software life cycle .35
201.15 Construction of ME EQUIPMENT .35
201.15. 3.5.101 Additional requirements for rough handling .35
201.15. 3.5.101.1 * Shock and vibration .35
201.15. 3.5.101.2 * Shock and vibration for a MOBILE VENTILATOR .36
201.15. 101 Mode of operation .37
201.15. 102 Delivered Oxygen concentration .38
201.15. 103 ACCESSORY self-check .38
201.16 ME SYSTEMS .38
201.16. 1.101 Additional general requirements for ME SYSTEMS .38
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .38
201.17. 101 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS .38
201.101 Gas connections .38
201.101. 1 * Protection against reverse gas leakage .38
201.101. 2 Connection to the MEDICAL GAS PIPELINE SYSTEM .39
201.101. 3 VBS connectors .39
201.101. 3.1 * General .39
201.101. 3.2 Other named ports .39
201.101. 3.2.1 PATIENT-CONNECTION PORT .39
201.101. 3.2.2 GAS OUTPUT PORT and GAS RETURN PORT .39
201.101. 3.2.3 MANUAL ventilation port .39
201.101. 3.2.4 EMERGENCY INTAKE PORT .40
iv © ISO 2011 – All rights reserved

ISO 80601-2-12:2011(E)
201.101. 3.2.5 FLOW-DIRECTION-sensitive components . 40
201.101. 3.2.6 ACCESSORY port . 40
201.101. 3.2.7 Monitoring probe port . 40
201.101. 3.2.8 Gas EXHAUST PORT . 40
201.102 Requirements for the VBS and ACCESSORIES . 40
201.102. 1 * General . 40
201.102. 2 Labelling . 40
201.102. 3 Breathing tubes . 41
201.102. 4 * Water management . 41
201.102. 4.1 Humidification system . 41
201.102. 4.2 HEAT AND MOISTURE EXCHANGER (HME) . 41
201.102. 5 Gas mixers . 41
201.102. 6 BREATHING SYSTEM FILTERS . 41
201.102. 7 VENTILATOR BREATHING SYSTEMS . 41
201.102. 7.1 Leakage from complete VBS . 41
201.102. 7.2 * Non-invasive ventilation . 42
201.103 * Spontaneous breathing during loss of power supply . 42
201.104 * Training . 43
201.105 * Indication of duration of operation . 43
201.106 SIGNAL INPUT/OUTPUT PART . 43
201.106. 1 General . 43
201.106. 2 * Connection to an electronic health record . 43
201.106. 3 * Connection to a DISTRIBUTED ALARM SYSTEM . 43
201.106. 4 * Connection for remote control . 43
201.107 Display loops . 43
201.107. 1 Pressure-volume loops . 43
201.107. 2 Flow-volume loops . 44
201.108 * Timed ventilatory pause . 44
201.108. 1 Expiratory pause . 44
201.108. 2 Inspiratory pause. 44
202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests . 45
202.6.2.1.10 * Compliance criteria . 45
206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability . 46
208 Medical electrical equipment – Part 1-8: General requirements for basic safety and
essential performance – Collateral Standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical electrical systems . 47
208.6.3.3.2.101 * Additional requirements for characteristics of ALARM CONDITION logging . 47
208.6.8.3.101 Additional requirements for global indefinite ALARM SIGNAL inactivation states . 47
208.6.8.4.101 * Additional requirements for termination of ALARM SIGNAL inactivation . 47
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 48
Annex D (informative) Symbols on marking . 53
Annex AA (informative) Particular guidance and rationale . 55
Annex BB (informative) Reference to the Essential Principles . 72
Bibliography . 74
Alphabetized index of defined terms used in this particular standard . 77

ISO 80601-2-12:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 80601-2-12 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62, Electrical
equipment in medical practice, Subcommittee SC D, Electrical equipment. The draft was circulated for voting
to the national bodies of both ISO and IEC.
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 the third edition of IEC 60601-1.
The most significant changes are the following modifications:
 extending the scope to include the critical care VENTILATOR and its ACCESSORIES, where the characteristics
of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL PERFORMANCE of the VENTILATOR, and
thus not only the critical care VENTILATOR itself;
 identification of ESSENTIAL PERFORMANCE for a critical care VENTILATOR and its ACCESSORIES;
 modification of the obstruction of the expiratory limb (continuing AIRWAY PRESSURE) ALARM CONDITION
requirement;
and the following additions:
 tests for ventilation performance;
 tests for mechanical strength;
 new symbols;
 requirements for a critical care VENTILATOR as a component of an ME SYSTEM;
 tests for enclosure integrity (water ingress);
 tests for closed suction survivability of the VENTILATOR;
 tests for cleaning and disinfection procedures;
PATIENT from the gas pathways.
 consideration of contamination of the breathing gas delivered to the
vi © ISO 2011 – All rights reserved

ISO 80601-2-12:2011(E)
ISO 80601 consists of the following parts, under the general title Medical electrical equipment:
 Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
 Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic
workstation
 Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas
monitors
 Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for
body temperature measurement
 Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter
equipment for medical use
IEC 80601 consists of the following parts, under the general title Medical electrical equipment:
 IEC 80601-2-30: Particular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers
 IEC 80601-2-35: Particular requirements for the basic safety and essential performance of heating
devices using blankets, pads and mattresses and intended for heating in medical use
 IEC 80601-2-58: Particular requirements for the basic safety and essential performance of lens removal
devices and vitrectomy devices for ophthalmic surgery
 IEC 80601-2-59: Particular requirements for the basic safety and essential performance of screening
thermographs for human febrile temperature screening
 IEC 80601-2-60: Particular requirements for basic safety and essential performance of dental equipment
The ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards.

ISO 80601-2-12:2011(E)
Introduction
In this International Standard, the following print types are used:
 Requirements and definitions: roman type.
 Test specifications: 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.
 TERMS DEFINED IN IEC 60601-1:2005, CLAUSE 3, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL
CAPITALS TYPE.
In referring to the structure of this standard, the term
 “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
 “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this International Standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular International Standard are by number only.
In this International Standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this International Standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this International Standard, the auxiliary verb:
 “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
 “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
 “may” is used to describe a permissible way to achieve compliance with a requirement or test.
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.
The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
and testing organizations may need a transitional period following publication of a new, amended or revised
ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
this International Standard not be adopted for mandatory implementation nationally earlier than 3 years from
the date of publication for equipment newly designed, and not earlier than 5 years from the date of publication
for equipment already in production.

viii © ISO 2011 – All rights reserved

INTERNATIONAL STANDARD ISO 80601-2-12:2011(E)

Medical electrical equipment —
Part 2-12:
Particular requirements for basic safety and essential
performance of critical care ventilators
201.1 Scope, object and related standards
IEC 60601-1:2005, Clause 1 applies, except as follows:
201.1.1 Scope
Subclause 1.1 of IEC 60601-1:2005, Clause 1 is replaced by:
This International Standard 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
NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.
 intended for use in critical care environments in a professional healthcare facility or intended for use in
transport within a professional healthcare facility.
NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not
considered an emergency and transport ventilator.
This International Standard 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.
This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes
intended for patients who are not dependent on mechanical ventilation.
NOTE 3 A critical care VENTILATOR, when operating in such a mode, is not considered LIFE-SUPPORTING ME EQUIPMENT OR
ME 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 standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13
and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005, 4.2.
ISO 80601-2-12:2011(E)
This International Standard 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
[26]
(HFJVs) and high-frequency oscillatory ventilators (HFOVs). This International Standard 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.
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
anaesthetic applications which are given in ISO 80601-2-13.
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
1)
home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-2 .
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
2)
emergency and transport which are given in ISO 10651-3 .
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for
3)
home-care ventilatory support devices which are given in ISO 10651-6 .
201.1.2 Object
Subclause 1.2 of IEC 60601-1:2005 is replaced by:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for a VENTILATOR, as defin
...