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

General Information

Status

Not Published

ICS

11.040.10 - Anaesthetic, respiratory and reanimation equipment

Technical Committee

ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care

Drafting Committee

ISO/TC 121/SC 3/JWG 1 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Critical care ventilators

Parallel Committee

IEC/SC 62D - Electromedical equipment

Current Stage

5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat

Start Date

05-Jun-2023

Completion Date

05-Jun-2023

Ref Project

Relations

Consolidates

ISO 7053:2019 - Fasteners — Hexagon washer head tapping screws

Effective Date

06-Jun-2022

Revises

ISO 80601-2-12:2020 - Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

Effective Date

19-Jun-2021

Buy Standard

REDLINE ISO/FDIS 80601-2-12.2 - Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Released:9/19/2022

Draft

REDLINE ISO/FDIS 80601-2-12.2 - Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators Released:9/19/2022

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ISO/FDIS 80601-2-12.2 - Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
Released:9/19/2022

Draft

ISO/FDIS 80601-2-12.2 - Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators Released:9/19/2022

English language

156 pages

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Standards Content (Sample)

INTERNATIONAL STANDARD ISO 80601-2-12:2019(E)
ISO/TC 121/SC 3/JWG 12
ISO/FDIS 80601-2-12:20212022(Ed 3)
2022-07-20
Secretariat: ANSI

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

Draft FDIS stage
Warning for WDs and CDs

This document is not an ISO International Standard. It is distributed for review and comment. It is subject to

change without notice and may not be referred to as an International Standard.

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 2015 – All rights reserved 1
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ISO 80601-2-12:2022(E)
© ISO 2022

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
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.
© ISO 2022 – All rights reserved
ii © ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 80601-2-12:2022(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............................................................................................................................ 25

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 ........................................................ 36

201.9 Protection against mechanical hazards of ME equipment and ME systems ........................... 36

201.10 Protection against unwanted and excessive radiation hazards ............................................... 40

201.11 Protection against excessive temperatures and other hazards ............................................... 40

201.12 Accuracy of controls and instruments and protection against

hazardous outputs .................................................................................................................................. 44

201.13 Hazardous situations and fault conditions for ME equipment ................................................... 62

201.14 Programmable electrical medical systems (PEMS) ........................................................................ 64

201.15 Construction of ME equipment ............................................................................................................ 65

201.16 ME systems ................................................................................................................................................. 68

201.17 Electromagnetic compatibility of ME equipment and ME systems ........................................... 69

201.101 Gas connections ....................................................................................................................................... 69

201.102 Requirements for the VBS and accessories ...................................................................................... 72

201.103 Spontaneous breathing during loss of ventilation ....................................................................... 74

201.104 Indication of duration of operation ................................................................................................... 75

201.105 Functional connection............................................................................................................................. 75

201.106 Display loops ............................................................................................................................................. 76

201.107 Timed ventilatory pause ....................................................................................................................... 77

202 Electromagnetic disturbances — Requirements and tests ........................................................ 78

206 Usability...................................................................................................................................................... 79

208 General requirements, tests and guidance for alarm systems in

medical electrical equipment and medical electrical systems ................................................. 81

Annex C (informative) Guide to marking and labelling requirements

for ME equipment and ME systems ..................................................................................................... 85

Annex D (informative) Symbols on marking ........................................................................................................ 90

Annex AA (informative) Particular guidance and rationale ........................................................................... 92

Annex BB (informative) Data interfaces ............................................................................................................ 133

Annex CC (informative) Reference to the IMDRF essential principles

and labelling guidances ...................................................................................................................... 142

Annex DD (informative) Reference to the essential principles ................................................................... 145

Bibliography ................................................................................................................................................................ 148

Alphabetized index of defined terms .................................................................................................................. 153

Figures
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ISO 80601-2-12:2022(E)

Figure 201.101 — Typical closed suctioning test setup .................................................................................. 39

Figure 201.102 — Typical test setup for volume- and pressure-control

inflation-type accuracy ............................................................................................................................................... 46

Figure 201.103 — Oxygen concentration change test setup .......................................................................... 53

Figure AA.1 — Pressure drop calculation for 3,0 mm ETT, 100 % RH room air

at sea level, 37°C, using approach specified in Reference [60] .................................................................. 111

Figure AA.2 — Pressure waveforms as a function of time during volume-

control breath delivery to a patient with acute severe asthma .................................................................. 117

Figure AA.3 — VBS leakage flowrate limits as a function of pressure

as specified in ISO 80601-2-12 and ISO 80601-2-13 ..................................................................................... 129

Tables

Table 201.101 — Distributed essential performance requirements ........................................................... 25

Table 201.102 — Test conditions for acoustic tests ......................................................................................... 37

Table 201.103 — Examples of permissible combinations of temperature and

relative humidity .......................................................................................................................................................... 41

Table 201.104 — Volume-control inflation-type testing .................................................................................. 47

Table 201.105 — Pressure-control inflation-type testing ................................................................................ 50

Table 201.106 — Test conditions for oxygen concentration change tests ................................................ 53

Table 201.C.101 — Marking on the outside of a ventilator, its parts or accessories .............................. 85

Table 201.C.102 — Accompanying documents, general ................................................................................... 86

Table 201.C.103 — Instructions for use ................................................................................................................. 86

Table 201.C.104 — Technical description ............................................................................................................. 89

Table 201.D.2.101 — Additional symbols on marking ..................................................................................... 90

Table AA.1 — Flow and pressure drop for linear and parabolic resistors ............................................. 111

Table AA.2 — Flow and pressure drop for linear and parabolic resistors ............................................. 112

Table AA.3 — Calculated conductance values by tidal volume range ....................................................... 127

Table BB.101 — Parameters and units of measurement ............................................................................. 134

Table BB.102 — Equipment identification ....................................................................................................... 134

Table BB.103 — Usage monitoring ...................................................................................................................... 135

Table BB.104 — Equipment settings .................................................................................................................. 136

Table BB.105 — Ventilation monitoring ........................................................................................................... 138

Table BB.106 — Ventilator alarm limits ............................................................................................................ 139

Table BB.107 — Event information ..................................................................................................................... 140

Table BB.108 —Service monitoring .................................................................................................................... 141

Table CC.1 — Correspondence between this document and the essential principles ......................... 142

Table CC.2 — Correspondence between this document and the labelling principles ........................ 144

Table DD.1 — Correspondence between this document and the essential principles ........................ 145

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 or
www.iec.ch/members_experts/refdocs).

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 https://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 conformance 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. In the IEC, see www.iec.ch/understanding-standards.

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,

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 third edition cancels and replaces the second edition (ISO 80601-2-12:2020), which has been

technically revised.
The main changes are as follows:
— alignment with IEC 60601-1:2005+AMD1:2012+AMD2:2020,
IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020 and
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020.

— added requirements for the display legibility for operators wearing personal protective equipment;

— added requirements for display during calibration of gas monitors;
— clarified maximum limited pressure requirements;
© ISO 2022 – All rights reserved
© ISO 2022 – All rights reserved v
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ISO 80601-2-12:2022(E)
— clarified high airway pressure alarm condition requirements;
— added requirements for ventilator system recovery; and
— harmonization with ISO 20417, where appropriate.

A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.

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 and www.iec.ch/national-

committees.
© ISO 2022 – All rights reserved
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ISO 80601-2-12:2022(E)
Introduction
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.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— "can" is used to describe a possibility or capability.

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.

Requirements in this document have been decomposed so that each requirement is uniquely

delineated. This is done to support automated requirements tracking.
© ISO 2022 – All rights reserved
© ISO 2022 – All rights reserved vii
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FINAL DRAFT INTERNATIONAL STANDARD ISO 80601-2-12:2022(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+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

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 2 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 3 For the purposes of this document, such a ventilator can provide ventilation during transport

within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 4 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 use a physiologic closed-loop-control system unless it uses a

physiological patient variable to adjust the artificial ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to

a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect

the basic safety or essential performance of the ventilator.
© ISO 2022 – All rights reserved 1
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ISO 80601-2-12:2022(E)

NOTE 5 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+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

This document is not applicable to ME equipment or an ME system operating in a ventilator-operational

mode solely intended for patients who are not dependent on artificial ventilation.

NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-

sustaining.

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:

NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.

 ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13;

 ventilators or accessories intended for the emergency medical services environment, which are given

in ISO 80601-2-84;

 ventilators or accessories intended for ventilator-dependent patients in the home healthcare

environment, which are given in ISO 80601-2-72;

 ventilators or accessories intended for home-care ventilatory support devices, which are given in

ISO 80601-2-79 and ISO 80601-2-80;

 obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70;

 high-frequency ventilators, which are given in ISO 80601-2-87;

NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory

ventilator-operational modes.
 respiratory high-flow therapy equipment, which are given in ISO 80601-2-90;

NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is

only for spontaneously breathing patients.
 oxygen therapy constant flow ME equipment; and
 cuirass or “iron-lung” ventilation equipment.
201.1.2 Object
Replacement:
2 © ISO 2022 – All rights reserved
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ISO 80601-2-12:2022(E)

The object of this document is to establish basic safety and essential performance requirements for a

ventilator, as defined in 201.3.306, and its accessories.

Accessories are included because the combination of the ventilator and the accessories needs to be

adequately safe. Accessories can have a significant impact on the basic safety or essential performance of

a ventilator.
[42] [43]

NOTE 1 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 2 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 3 This document has been prepared to address the relevant general safety and performance requirements

of European regulation (EU) 2017/745.
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 in 201.2 of this document.
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and

IEC 60601-1-8:2016+AMD1:2012+AMD2:2020 apply as modified in Clauses 202, 206 and 208

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.

201.1.43 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 the

general standard) or applicable collateral standard with the prefix “2xx” where xx are 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+AMD1:2012+AMD2:2020 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+AMD1:2012+AMD2:2020 or the applicable collateral standard.

“Amendment” means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+AMD2:2020 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 3.154, 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, 208 for IEC 60601-1-

8, 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+AMD2:2020 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+AMD2:2020 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.

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
Replacement:

ISO 15223-1:2021, Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements
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 2022 – All rights reserved
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ISO 80601-2-12:2022(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+AMD1:2017, Medical gas pipeline systems — Part 1: Pipeline systems for compressed

medical gases and vacuum

ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for

humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml

ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for

humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having

minimum tidal volumes of 250 ml

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 17664-1:2021, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices — Part 2: Non-critical 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 20417:2021, 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 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the basic

safety and essential performance of respiratory gas monitors
ISO 80601-2-
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 80601-2-12
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 2-12:
2022-10-03
Particular requirements for basic
Voting terminates on:
safety and essential performance of
2022-11-28
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
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
ISO/CEN PARALLEL PROCESSING
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 80601-2-12:2022(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2022
---------------------- Page: 1 ----------------------
ISO/FDIS 80601-2-12:2022(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 80601-2-12
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 2-12:
Particular requirements for basic
Voting terminates on:
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
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
ISO/CEN PARALLEL PROCESSING

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.
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ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
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DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 80601-2-12:2022(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
© ISO 2022 – All rights reserved
NATIONAL REGULATIONS. © ISO 2022
---------------------- Page: 2 ----------------------
ISO 80601-2-12:2022(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 .............................................................................................................................. 24

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 ......................................................... 36

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 ............................................... 40

201.12 Accuracy of controls and instruments and protection against

hazardous outputs ..................................................................................................................................... 43

201.13 Hazardous situations and fault conditions for ME equipment ................................................... 62

201.14 Programmable electrical medical systems (PEMS) ......................................................................... 64

201.15 Construction of ME equipment .............................................................................................................. 65

201.16 ME systems .................................................................................................................................................... 68

201.17 Electromagnetic compatibility of ME equipment and ME systems ........................................... 69

201.101 Gas connections .......................................................................................................................................... 69

201.102 Requirements for the VBS and accessories ....................................................................................... 72

201.103 Spontaneous breathing during loss of ventilation ........................................................................ 74

201.104 Indication of duration of operation..................................................................................................... 75

201.105 Functional connection ............................................................................................................................... 75

201.106 Display loops ................................................................................................................................................ 76

201.107 Timed ventilatory pause ......................................................................................................................... 77

202 Electromagnetic disturbances — Requirements and tests ........................................................ 78

206 Usability ......................................................................................................................................................... 79

208 General requirements, tests and guidance for alarm systems in

medical electrical equipment and medical electrical systems ................................................. 81

Annex C (informative) Guide to marking and labelling requirements

for ME equipment and ME systems ....................................................................................................... 85

Annex D (informative) Symbols on marking .......................................................................................................... 90

Annex AA (informative) Particular guidance and rationale ............................................................................ 92

Annex BB (informative) Data interfaces ............................................................................................................... 132

Annex CC (informative) Reference to the IMDRF essential principles

and labelling guidances ......................................................................................................................... 141

Annex DD (informative) Reference to the essential principles ..................................................................... 144

Bibliography .................................................................................................................................................................... 147

Alphabetized index of defined terms ..................................................................................................................... 152

© ISO 2022 – All rights reserved iii
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ISO 80601-2-12:2022(E)
Figures

Figure 201.101 — Typical closed suctioning test setup .................................................................................... 39

Figure 201.102 — Typical test setup for volume- and pressure-control

inflation-type accuracy ................................................................................................................................................... 46

Figure 201.103 — Oxygen concentration change test setup ........................................................................... 53

Figure AA.1 — Pressure drop calculation for 3,0 mm ETT, 100 % RH room air

at sea level, 37°C, using approach specified in Reference [60] ..................................................................... 111

Figure AA.2 — Pressure waveforms as a function of time during volume-

control breath delivery to a patient with acute severe asthma .................................................................... 117

Figure AA.3 — VBS leakage flowrate limits as a function of pressure

as specified in ISO 80601-2-12 and ISO 80601-2-13 ........................................................................................ 128

Tables

Table 201.101 — Distributed essential performance requirements ............................................................ 25

Table 201.102 — Test conditions for acoustic tests ........................................................................................... 37

Table 201.103 — Examples of permissible combinations of temperature and

relative humidity ............................................................................................................................................................. 40

Table 201.104 — Volume-control inflation-type testing .................................................................................... 46

Table 201.105 — Pressure-control inflation-type testing ................................................................................. 49

Table 201.106 — Test conditions for oxygen concentration change tests ................................................. 53

Table 201.C.101 — Marking on the outside of a ventilator, its parts or accessories ............................... 85

Table 201.C.102 — Accompanying documents, general ..................................................................................... 86

Table 201.C.103 — Instructions for use ................................................................................................................... 86

Table 201.C.104 — Technical description ............................................................................................................... 89

Table 201.D.2.101 — Additional symbols on marking ....................................................................................... 90

Table AA.1 — Flow and pressure drop for linear and parabolic resistors ............................................... 111

Table AA.2 — Flow and pressure drop for linear and parabolic resistors ............................................... 112

Table AA.3 — Calculated conductance values by tidal volume range ......................................................... 127

Table BB.101 — Parameters and units of measurement ................................................................................ 133

Table BB.102 — Equipment identification ........................................................................................................... 133

Table BB.103 — Usage monitoring ......................................................................................................................... 134

Table BB.104 — Equipment settings ...................................................................................................................... 135

Table BB.105 — Ventilation monitoring ............................................................................................................... 137

Table BB.106 — Ventilator alarm limits ................................................................................................................ 138

Table BB.107 — Event information ........................................................................................................................ 139

Table BB.108 —Service monitoring ........................................................................................................................ 140

Table CC.1 — Correspondence between this document and the essential principles ........................... 141

Table CC.2 — Correspondence between this document and the labelling principles .......................... 143

Table DD.1 — Correspondence between this document and the essential principles ......................... 144