IEC 60601-2-12:2001

Medical electrical equipment — Part 2-12: Particular requirements for the safety of lung ventilators — Critical care ventilators

Appareils électromédicaux — Partie 2-12: Règles particulières de sécurité pour ventilateurs pulmonaires — Ventilateurs pour utilisation en soins intensifs

General Information

• Status: Withdrawn
• Publication Date: 05-Dec-2001
• Withdrawal Date: 05-Dec-2001
• 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 - Respiratory devices and related equipment used for patient care
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 18-Jul-2013

Relations

• Revised: ISO 80601-2-12:2011 - Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
• Effective Date: 27-Jul-2013
• Revises: ISO 10651-1:1993 - Lung ventilators for medical use — Part 1: Requirements
• Effective Date: 15-Apr-2008

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-12
[ISO 10651-1]
Second edition
2001-10
Medical electrical equipment –
Part 2-12:
Particular requirements for the safety of lung
ventilators – Critical care ventilators
Appareils électromédicaux –
Partie 2-12:
Règles particulières de sécurité pour ventilateurs
pulmonaires – Ventilateurs pour utilisation en soins intensifs
Reference number
IEC 60601-2-12:2001(E)

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Publication numbering
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INTERNATIONAL IEC
STANDARD
60601-2-12
[ISO 10651-1]
Second edition
2001-10
Medical electrical equipment –
Part 2-12:
Particular requirements for the safety of lung
ventilators – Critical care ventilators
Appareils électromédicaux –
Partie 2-12:
Règles particulières de sécurité pour ventilateurs
pulmonaires – Ventilateurs pour utilisation en soins intensifs
 IEC 2001  Copyright - all rights reserved
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 the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
PRICE CODE
S
For price, see current catalogue

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– 2 – 60601-2-12 © IEC:2001(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
SECTION ONE – GENERAL
1 Scope and object .7
2 Terminology and definitions .8
3 General requirements .12
4 General requirements for tests.12
5 Classification .12
6 Identification, marking and documents .12
7 Power input .16
SECTION TWO – ENVIRONMENTAL CONDITIONS
8 Basic safety categories .16
9 Removable protective means .16
10 Environmental conditions .16
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General .17
14 Requirements related to classification .17
15 Limitation of voltage and/or energy.17
16 ENCLOSURES and PROTECTIVE COVERS.17
17 Separation.18
18 Protective earthing, functional earthing and potential equalization.18
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.18
20 Dielectric strength.18
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.18
22 Moving parts.18
23 Surfaces, corners and edges .18
24 Stability in NORMAL USE.18
25 Expelled parts.18
26 Vibration and noise .18
27 Pneumatic and hydraulic power.19
28 Suspended masses .19
SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 X-radiation.19
30 Alpha, beta, gamma, neutron radiation and other particle radiation .19
31 Microwave radiation .19
32 Light radiation (including lasers).19
33 Infra-red radiation .19
34 Ultra-violet radiation.19

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60601-2-12 © IEC:2001(E) – 3 –
35 Acoustical energy (including ultrasonics) .19
36 Electromagnetic compatibility.19
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and basic requirements .20
38 Marking, ACCOMPANYING DOCUMENTS .20
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT .20
40 Requirements and tests for CATEGORY AP EQUIPMENT, parts and components thereof.20
41 Requirements and tests for CATEGORY APG EQUIPMENT, parts and components thereof .20
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.20
43 * Fire prevention .20
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility .21
45 Pressure vessels and parts subject to pressure.21
46 Human errors .22
47 Electrostatic charges .22
48 Biocompatibility.22
49 Interruption of the power supply .22
SECTION EIGHT – ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.23
51 Protection against hazardous output .24
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions.26
53 Environmental tests .26
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General .27
55 ENCLOSURES and covers .27
56 Components and general assembly.27
57 MAINS PARTS, components and layout.29
58 Protective earthing – Terminals and connections.30
59 Construction and layout .30
Appendix L References – Publications mentioned in this standard .31
Annex AA (informative) Rationale .34
Annex BB (normative) Legibility and visibility of visual indications .39
Annex CC (informative) Intelligent alarm systems .40
Bibliography .41
Terminology – Index of defined terms.42

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-12: Particular requirements for the safety of lung ventilators –
Critical care ventilators
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization, comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international cooperation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters, express as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides, and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national standard shall be clearly indicated in the
latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. IEC shall not be held responsible for identifying any such patent rights.
International Standard IEC 60601-2-12 has been prepared by subcommittee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
ISO TC 121/SC 3, Lung ventilators and related equipment, also participated in the preparation
of this standard.
This second edition replaces the first edition of IEC 60601-2-12:1988, Medical electrical
equipment – Part 2: Particular requirements for the safety of lung ventilators for medical use,
and ISO 10651-1:1993, Lung ventilators for medical use – Part 1: Requirements.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/414/FDIS 62D/440/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
Annex BB forms an integral part of this standard.
Annexes AA and CC are for information only.

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60601-2-12 © IEC:2001(E) – 5 –
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– notes, explanations, advice, introductions, general statements and references: smaller roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 60601-1 OR IN THIS PARTICULAR
STANDARD: SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2004. At this date, the publication will be:
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
NOTE IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for safety – Collateral
Standard: General requirements and guidelines for the application of alarms in medical electrical equipment is
currently under development. This Standard will require maintenance to conform to that Collateral Standard.

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INTRODUCTION
Critical care VENTILATORS are an essential medical device in every intensive care unit (ICU).
Approximately half of all PATIENTS in ICUs receive partial to full ventilatory support with this
EQUIPMENT. Given the vulnerable status of these PATIENTS, EQUIPMENT safety is of fundamental
importance. Accordingly, this Particular Standard, by building on other standards and
specifically on IEC 60601-1: Medical electrical equipment – Part 1: General requirements for
safety, herein referred to as the “General Standard”, sets the minimum requirements that
should be met by every critical care VENTILATOR that is designed after the publication of this
Particular Standard.
A rationale for the most important requirements is given in Annex AA.
Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, support-
care VENTILATORs, anaesthesia, emergency and transport VENTILATORs, jet and high frequency
VENTILATOR and oscillators are not covered by this Particular Standard, nor are devices that
may be used within hospitals, intended solely to augment the ventilation of spontaneously
breathing PATIENTS.

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60601-2-12 © IEC:2001(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-12: Particular requirements for the safety of lung ventilators –
Critical care ventilators
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies, except as follows:
1.1 Scope
Addition:
This Particular Standard specifies the safety requirements for VENTILATORS, as defined in
2.1.125, intended for use in critical care settings.
Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, support-
care VENTILATORs, emergency and transport VENTILATORs, jet and high frequency VENTILATORs
and oscillators are outside the scope of this Particular Standard, nor are devices that may be
used within hospitals, intended solely to augment the ventilation of spontaneously breathing
PATIENTS. Standards for other types of VENTILATORs, e.g. high frequency jet and oscillation
ventilators, are under consideration.
Requirements for VENTILATORs intended for anaesthetic applications are given in IEC 60601-2-13.
1.2 Object
Addition:
The object of this standard is to specify particular safety requirements for VENTILATORS
intended for use in critical care settings.
1.3 Particular standards
Addition:
This Particular Standard refers to IEC 60601-1:1988, Medical electrical equipment – Part 1:
General requirements for safety, as amended by its amendment 1 (1991) and its amendment 2
(1995), herein referred to as the “General Standard”.
The General Standard takes into account a set of Collateral Standards:
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requirements for safety,
Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001, Medical electrical equipment – Part 1-2: General requirements for safety
– Collateral standard: Electromagnetic compatibility – Requirements and tests

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IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety, 4.
Collateral standard: Programmable electrical medical systems
1
Amendment 1
The term “this Standard” covers this Particular Standard, used together with the General
Standard and the Collateral Standards.
The numbering of sections, clauses, and subclauses of this Particular Standard corresponds
with that of the General Standard. 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 the General Standard is replaced
completely by the text of this Particular Standard.
– “Addition” means that the text of this Particular Standard is additional to the requirements of
the General Standard.
– “Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures that are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
Clauses and subclauses to which there is a rationale are marked with an asterisk *. These
rationales can be found in an informative Annex AA.
Annexes AA and CC are not normative parts of this Particular Standard and only provide
additional information; they can never be the subjects of testing.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard or specified Collateral Standard applies
without modification.
Where it is intended that any part of the General Standard or Collateral Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General
Standard or a Collateral Standard takes precedence over the corresponding general
requirement(s).
2 Terminology and definitions
This clause of the General Standard applies, except as follows:
* 2.1.5
applied part
Addition:
or any part of the VENTILATOR intended to be connected to the breathing system
___________
1
There exists a consolidated edition 1.1 (2000) that includes IEC 60601-1-4 (1996) and its amendment 1 (1999).

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60601-2-12 © IEC:2001(E) – 9 –
Additional definitions:
2.1.101
bacterial filter
device that removes bacteria and particulate matter from the gas stream
[ISO 4135:1995, definition 4.1.7 modified]
2.1.102
clearly legible
visual attribute of information displayed by the EQUIPMENT that allows the OPERATOR to discern
(or identify) qualitative or quantitative values or functions under a specific set of environmental
conditions
2.1.103
emergency air intake port
dedicated intake port through which ambient air may be drawn when the supply of FRESH GAS is
insufficient or absent
[ISO 4135:1995, definition 4.2.2 modified]
2.1.104
flow-direction-sensitive component
VENTILATOR component through which the gas flow has to be in one direction only for its proper
functioning and/or PATIENT safety
[ISO 4135:1995, definition 4.1.13]
2.1.105
fresh gas
gas supplied to the VENTILATOR BREATHING SYSTEM. It excludes the following:
– air drawn through the EMERGENCY AIR INTAKE PORT;
– air drawn through leaks in the VENTILATOR BREATHING SYSTEM;
– expired gas from the PATIENT
2.1.106
fresh gas intake port
intake port, other than the EMERGENCY AIR INTAKE PORT, through which FRESH GAS may be
drawn into the VENTILATOR BREATHING SYSTEM
[ISO 4135:1995, definition 4.2.6 modified]
2.1.107
gas exhaust port
that port of a VENTILATOR from which gas is discharged to the atmosphere either directly or via
a gas scavenging system
[ISO 4135:1995, definition 4.2.7]
2.1.108
gas intake port
port through which gas is drawn into the VENTILATOR BREATHING SYSTEM

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2.1.109
gas output port
port through which gas is delivered at RESPIRATORY PRESSURES via the inspiratory limb to the
PATIENT CONNECTION PORT
[ISO 4135:1995, definition 4.2.8 modified]
2.1.110
gas return port
port through which gas is returned at RESPIRATORY PRESSURES via the expiratory limb from the
PATIENT CONNECTION PORT
[ISO 4135:1995, definition 4.2.9 modified]
2.1.111
high pressure gas input port
input port to which gas may be supplied at a pressure greater than 100 kPa
[ISO 4135:1995, definition 4.2.10 modified]
2.1.112
inflating gas
FRESH GAS that may also power the VENTILATOR
2.1.113
inflating gas input port
input port to which INFLATING GAS is supplied
[ISO 4135:1995, definition 4.2.11]
NOTE An input port is a port to which gas is supplied under positive pressure and through which the gas is driven
by this pressure. The gas may be supplied either at a controlled pressure or at a controlled flow.
2.1.114
inhibition
(disabled)
state in which an alarm system or part of an alarm system can not annunciate alarm signals
NOTE 1 INHIBITION may apply to an individual alarm condition, to a group of alarm conditions, or to the entire alarm
system of the EQUIPMENT.
NOTE 2 INHIBITION may be invoked by the OPERATOR or by the EQUIPMENT (for instance, in a warm-up mode or
when no PATIENT is connected).
NOTE 3 The duration of INHIBITION is always indefinite. Only direct action by the OPERATOR or a change in the
EQUIPMENT caused by the OPERATOR (for instance, the end of a warm-up mode or when a PATIENT is connected) will
revoke INHIBITION.
2.1.115
low-pressure gas input port
input port to which gas is supplied at a pressure not exceeding 100 kPa
[ISO 4135:1995, definition 4.2.14]
2.1.116
manual ventilation port
port to which a device may be connected for manual inflation of the lungs
[ISO 4135:1995, definition 4.2.15 modified]
2.1.117
maximum limited pressure (P max)

LIM
Highest pressure at the PATIENT CONNECTION PORT during NORMAL USE and under a SINGLE
FAULT CONDITION

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60601-2-12 © IEC:2001(E) – 11 –
2.1.118
maximum working pressure (P max)
W
highest pressure at the PATIENT CONNECTION PORT during NORMAL USE, irrespective of the
setting of controls, other than the control intended to adjust this pressure
NOTE Even if not adjustable, this maximum is equal to or less than the MAXIMUM LIMITED PRESSURE.
2.1.119
minimum limited pressure (P min)
LIM
lowest pressure at the PATIENT CONNECTION PORT during NORMAL USE and under a SINGLE FAULT
CONDITION
NOTE This pressure may be sub-atmospheric.
2.1.120
&
minute volume (V )
volume of gas per minute entering or leaving the lungs of the PATIENT
2.1.121
operator’s position
intended location and orientation of the OPERATOR with respect to the EQUIPMENT for NORMAL
USE according to the instructions for use
2.1.122
patient connection port (of the VENTILATOR BREATHING SYSTEM)
port of the VENTILATOR BREATHING SYSTEM to which the PATIENT can be connected
[ISO 4135:1995, definition 4.2.16]
NOTE Interface between the VENTILATOR BREATHING SYSTEM and the PATIENT.
2.1.123
respiratory pressure
pressure at the PATIENT CONNECTION PORT
2.1.124
suspended
state of an alarm system where OPERATOR action has temporarily caused an otherwise enabled
alarm system to disable all auditory or all auditory and visual alarm signals for a fixed interval
2.1.125
ventilator
automatic EQUIPMENT that is intended to augment or provide ventilation of the lungs of the
PATIENT when connected to the airway of the PATIENT
2.1.126
ventilator breathing system (VBS)
breathing system bounded by the LOW PRESSURE GAS INPUT PORT(S), the GAS INTAKE PORT(S)
and the PATIENT CONNECTION PORT, together with the FRESH GAS INTAKE and EXHAUST PORT(S), if
these are provided
[ISO 4135:1995, definition 4.1.6 modified]

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3 General requirements
This clause of the General Standard applies, except as follows:
* 3.1
Addition:
Any fault that can lead to a hazard and that is not detected by intrinsic means or by periodic
inspection (e.g. an oxidant leak, software defect) shall be regarded as a NORMAL CONDITION and
not a SINGLE FAULT CONDITION.
3.4
Addition:
An equivalent degree of safety may be demonstrated by means of a risk analysis, in
accordance with ISO 14971.
4 General requirements for tests
This clause of the General Standard applies.
5 Classification
This clause of the General Standard applies, except as follows:
5.2
Addition:
NOTE A VENTILATOR may have APPLIED PARTS of different types.
6 Identification, marking and documents
This clause of the General Standard applies, except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
e) Indication of origin
Addition (after the existing sentence):
The name and address of the manufacturer or authorized representative, as applicable,
shall also be marked.
k) Mains power output
Replacement:
If provided, AUXILIARY MAINS SOCKET OUTLET(S) of EQUIPMENT shall be marked with the
maximum allowed output in amperes or volt-amperes.
q) Physiological effects
Addition (between the first and second paragraphs)
If applicable, a warning that latex is used.

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60601-2-12 © IEC:2001(E) – 13 –
Addition:
aa) Any HIGH PRESSURE GAS INPUT PORT shall be marked with the name or symbol of gas in
accordance with ISO 5359 and with the supply pressure range and the nominal maximum
flow requirements. If gas-specific color-coding of flow control or flexible hoses is
provided, it shall be in accordance with ISO 32.
bb) If OPERATOR accessible ports are provided, they shall be marked. The following terms
should be used.
− INFLATING GAS INPUT PORT: 'Inflating Gas Input'
− MANUAL VENTILATION PORT: 'Bag'
− GAS OUTPUT PORT: 'Gas Output'
− GAS RETURN PORT: 'Gas Return'
− GAS EXHAUST PORT: 'Exhaust'
Alternatively, other terms or symbols may be used in the above and explained in the
instructions for use.
− EMERGENCY AIR INTAKE PORT: 'WARNING: Emergency Air Intake – Do Not Obstruct'
cc) Any particular storage and/or handling instructions.
dd) Any particular warnings and/or precautions relevant to the immediate operation of the
VENTILATOR.
ee
...