ISO 80601-2-12:2020

Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

General Information

• Status: Published
• Technical Committee: COVID 19 - COVID 19 - ISO
• Directive: standardi COVID-19 - UPDATE ON THE AVAILABILITY OF CEN, CENELEC, ISO, IEC STANDARDS AND THEIR NATIONAL ADOPTIONS IN RESPONSE TO THE COVID-19 OUTBREAK

Standards Content (Sample)

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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INTERNATIONAL ISO
STANDARD 80601-2-12
Second edition
2020-02
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 80601-2-12:2020(E)
©
ISO 2020

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(E)

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ii © ISO 2020 – All rights reserved

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(E)
Contents
201. 1 Scope, object and related standards . 1
201. 1.1 * Scope . 1
201. 1.2 Object . 2
201. 1.3 Collateral standards . 3
201. 1.4 Particular standards . 3
201. 2 Normative references . 4
201. 3 Terms and definitions . 7
201. 4 General requirements . 9
201. 4.3 Essential performance . 9
201. 4.3.101 * Additional requirements for essential performance . 9
201. 4.4 Additional requirements for expected service life . 9
201. 4.6 * ME equipment or ME system parts that contact the patient . 10
201. 4.11.101 * Additional requirements for pressurized gas input . 10
201. 4.11.101.1 Overpressure requirement . 10
201. 4.11.101.2 Compatibility requirement . 10
201. 5 General requirements for testing of ME equipment. 11
201. 5.101 Additional requirements for general requirements for testing
of ME equipment . 11
201. 5.101.1 Ventilator test conditions . 11
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 . 12
201. 7 ME equipment identification, marking and documents . 12
201. 7.2.3 * Consult accompanying documents . 12
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 . 12
201. 7.2.18 External gas source . 13
201. 7.2.101 * Additional requirements for marking on the outside of
ME equipment or ME equipment parts . 13
201. 7.4.3 * Units of measurement . 14
201. 7.9.1 Additional general requirements . 14
201. 7.9.2.1.101 Additional general requirements . 14
201. 7.9.2.2.101 * Additional requirements for warnings and safety notices . 15
201. 7.9.2.8.101 * Additional requirements for start-up procedure . 16
201. 7.9.2.9.101 * Additional requirements for operating instructions . 16
201. 7.9.2.12 Cleaning, disinfection, and sterilization . 17
201. 7.9.2.14.101 * Additional requirements for accessories, supplementary
equipment, used material . 17
© ISO 2020 – All rights reserved iii

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(E)
201. 7.9.2.16.101 * Additional requirements for reference to the technical
description . 18
201. 7.9.3.1.101 * Additional general requirements . 18
201. 7.9.3.101 Additional requirements for the technical description . 18
201. 8 Protection against electrical hazards from ME equipment . 19
201. 9 Protection against mechanical hazards of ME equipment and ME systems 19
201. 9.6.2.1.101 * Additional requirements for audible acoustic energy . 19
201. 9.101 * Additional requirements for suction procedures . 20
201. 10 Protection against unwanted and excessive radiation hazards . 23
201. 11 Protection against excessive temperatures and other hazards . 23
201. 11.1.2.2 * Applied parts not intended to supply heat to a patient . 23
201. 11.6.5.101 * Additional requirements for ingress of water or particulate
matter into ME equipment or ME system . 23
201. 11.6.6 * Cleaning and disinfection of ME equipment or ME system . 24
201. 11.6.7 Sterilization of ME equipment or ME system . 24
201. 11.7 Biocompatibility of ME equipment and ME systems . 24
201. 11.8.101 * Additional requirements for interruption of the power
supply/supply mains to ME equipment . 25
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 27
201. 12.1 * Accuracy of controls and instruments . 27
201. 12.1.101 * Volume-control inflation-type . 27
201. 12.1.102 * Pressure-control inflation-type . 31
201. 12.1.103 Other inflation-types . 34
201. 12.1.104 * Inspiratory volume monitoring . 35
201. 12.1.105 * Response of the ventilator to an increase in set O
2
concentration . 35
201. 12.4 Protection against hazardous output . 37
201. 12.4.101 Oxygen monitor . 37
201. 12.4.102 * Measurement of airway pressure . 38
201. 12.4.103 * Measurement of expired volume and low volume alarm
conditions . 39
201. 12.4.103.1 Ventilators intended to provide a tidal volume >50 ml . 39
201. 12.4.103.2 Ventilators intended to provide a tidal volume ≤50 ml . 40
201. 12.4.104 * Expiratory end-tidal CO monitoring equipment . 41
2
201. 12.4.105 * Maximum limited pressure protection device . 42
201. 12.4.106 * High airway pressure alarm condition and protection device 42
201. 12.4.107 PEEP alarm conditions . 43
201. 12.4.108 * Obstruction alarm condition . 44
201. 12.4.109 * Disconnection alarm condition . 45
201. 12.4.110 Protection against inadvertent setting of high airway pressure .
 . 45
201. 12.101 * Protection against accidental or unintentional adjustments 45
201. 13 Hazardous situations and fault conditions for ME equipment . 46
iv © ISO 2020 – All rights reserved

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(E)
201. 13.2.101 * Additional specific single fault conditions . 46
201. 13.2.102 * Failure of one gas supply to a ventilator . 46
201. 13.2.103 * Independence of ventilation control function and related risk
control measures . 47
201. 13.2.104 * Failure of functional connection to a ventilator control or
monitoring means . 47
201. 14 Programmable electrical medical systems (PEMS) . 47
201. 14.101 Software life cycle . 48
201. 15 Construction of ME equipment . 48
201. 15.3.5.101 Additional requirements for rough handling . 48
201. 15.3.5.101.1 * Shock and vibration (robustness) . 48
201. 15.3.5.101.2 * Shock and vibration for a transit-operable ventilator during
operation . 49
201. 15.4.1 Construction of connectors . 51
201. 15.101 Mode of operation . 51
201. 15.102 Delivered oxygen concentration . 51
201. 15.103 Accessory self-check . 51
201. 16 ME systems . 52
201. 16.1.101 Additional general requirements for ME systems . 52
201. 16.2.101 * Additional general requirements for accompanying documents
of an ME system . 52
201. 17 Electromagnetic compatibility of ME equipment and ME systems. 52
201. 101 Gas connections . 52
201. 101.1 * Protection against reverse gas leakage . 52
201. 101.2 Connection to a high-pressure input port . 53
201. 101.2.1 Connector . 53
201. 101.2.2 * Filter . 53
201. 101.3 VBS connectors . 53
201. 101.3.1 * General . 53
201. 101.3.2 Other named ports . 53
201. 101.3.2.1 Patient-connection port . 53
201. 101.3.2.2 Gas output port and gas return port . 54
201. 101.3.2.3 Emergency intake port . 54
201. 101.3.2.4 Flow-direction-sensitive components. 54
201. 101.3.2.5 * Accessory port . 54
201. 101.3.2.6 Gas exhaust port . 55
201. 101.3.2.7 Temperature sensor port . 55
201. 102 Requirements for the VBS and accessories . 55
201. 102.1 * General . 55
201. 102.2 Labelling . 55
201. 102.3 Breathing tubes . 55
201. 102.4 * Water vapour management . 56
201. 102.4.1 Humidification system . 56
201. 102.4.2 Heat and moisture exchanger (HME) . 56
© ISO 2020 – All rights reserved v

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(E)
201. 102.6 Breathing system filters . 56
201. 102.7 Ventilator breathing systems . 56
201. 102.7.1 * Leakage from complete VBS . 56
201. 102.7.2 * Non-invasive ventilation . 57
201. 103 * Spontaneous breathing during loss of power supply . 57
201. 104 * Indication of duration of operation . 57
201. 105 Functional connection . 58
201. 105.1 General . 58
201. 105.2 * Connection to an electronic health record . 58
201. 105.3 * Connection to a distributed alarm system . 58
201. 105.4 Connection for remote control . 58
201. 106 Display loops . 58
201. 106.1 Pressure-volume loops . 58
201. 106.2 Flow-volume loops . 59
201. 107 * Timed ventilatory pause. 59
201. 107.1 Expiratory pause . 59
201. 107.2 Inspiratory pause . 60
202 Electromagnetic disturbances — Requirements and tests . 61
206 Usability . 62
206.101 Primary operating functions . 62
206.102 * Training . 63
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 64
Annex C (informative) Guide to marking and labelling requirements for
ME equipment and ME systems . 66
201.C.101 Marking on the outside of ME equipment, ME systems or their
parts . 66
201.C.102 Accompanying documents, general . 67

201.C.103 Accompanying documents, instructions for use . 67
201.C.104 Accompanying documents, technical description . 70
Annex D (informative) Symbols on marking . 71
Annex AA (informative) Particular guidance and rationale . 75
AA.1 General guidance. 75
AA.2 Rationale for particular clauses and subclauses . 75
Annex BB (informative) Data interfaces . 114
BB.1 Background and purpose . 114
BB.2 Data definition . 115
Annex CC (informative) Reference to the essential principles . 123
Annex DD (informative) Reference to the general safety and performance
requirements .126
Annex EE (informative) Terminology — Alphabetized index of defined terms . 129
Bibliography .134
vi © ISO 2020 – All rights reserved

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(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.
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 ISO documents 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 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).
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 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, Electric
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).
This second edition cancels and replaces the first edition (ISO 80601-2-12:2011), which has been
technically revised. It also incorporates the Technical Corrigendum ISO 80601-2-12:2011/Cor 1:2011.
The main changes compared to the previous edition are as follows:
— alignment with IEC 60601-1:2005+AMD1:2012, IEC 60601-1-8:2006+AMD1:2012, IEC
60601-1-2:2014 and IEC 60601-1-6:2010+AMD1:2013.
— determination of probability of component failure during the expected service life;
— delivered gas maximum enthalpy requirement;
— new test protocol for internal electrical power source operation time;
— performance test and disclosure requirements for other inflation-types;
— additional protections against hazardous outputs;
— clarification of performance requirements during abnormals testing;
— consideration of input gas of Oxygen 93 %; and
— harmonization of terminology with ISO 19223, where appropriate.
© ISO 2020 – All rights reserved vii

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(E)
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.

viii © ISO 2020 – All rights reserved

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
ISO 80601-2-12:2020(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 201.12 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.
© ISO 2020 – All rights reserved ix

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

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Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
INTERNATIONAL STANDARD ISO 80601-2-12:2020(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
Clause 1 of the general standard applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012.
201.1.1 * Scope
Replacement:
This document applies to the basic safety and essential performance of a ventilator 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.
Ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional
healthcare facility (i.e. be a transit-operable ventilator).
NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not
considered as an emergency medical services environment ventilator.
 intended to be operated by a healthcare professional operator; and
 intended for those patients who need differing levels of support from artificial ventilation
including for ventilator-dependent patients.
A critical care ventilator is not considered to utilize a physiologic clo
...