EN ISO 10651-2:2009

SLOVENSKI STANDARD
01-julij-2009
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SIST EN ISO 10651-2:2005
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Lung ventilators for medical use - Particular requirements for basic safety and essential
performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO
10651-2:2004)
Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die
grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 2:
Heimbeatmungsgeräte für vom Gerät abhängige Patienten (ISO 10651-2:2004)
Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de
base et les performances essentielles - Partie 2: Ventilateurs pour soins à domicile pour
patients dépendants (ISO 10651-2:2004)
Ta slovenski standard je istoveten z: EN ISO 10651-2:2009
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 10651-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 10651-2:2004
English Version
Lung ventilators for medical use - Particular requirements for
basic safety and essential performance - Part 2: Home care
ventilators for ventilator-dependent patients (ISO 10651-2:2004)
Ventilateurs pulmonaires à usage médical - Exigences Beatmungsgeräte für die medizinische Anwendung -
particulières pour la sécurité de base et les performances Besondere Festlegungen für die grundlegende Sicherheit
essentielles - Partie 2: Ventilateurs pour soins à domicile einschließlich der wesentlichen Leistungsmerkmale - Teil 2:
pour patients dépendants (ISO 10651-2:2004) Heimbeatmungsgeräte für vom Gerät abhängige Patienten
(ISO 10651-2:2004)
This European Standard was approved by CEN on 14 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10651-2:2009: E
worldwide for CEN national Members.

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

Foreword
The text of ISO 10651-2:2004 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
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 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 ISO 10651-2:2004.
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 EC Directive.
For relationship with EC Directive, 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, 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 10651-2:2004 has been approved by CEN as a EN ISO 10651-2:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 – Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
All 1, 2, 3
4 (3.1) 4, 12.1
4 (3.4) 2
5.2 12.6
6.1 2, 13.1
nd
6.1 7.5 (2 paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
6.1 e) 13.3 a) This relevant Essential
Requirement is not fully
addressed in this European
Standard
6.1 q) 7.1, 7.2, 13.3 k)
6.1 aa), 6.1 bb) 9.2, 13.2
6.1 cc) 13.3 i)
6.1 dd) 13.3 i), 13.6 k)
6.1 ee) 13.3 e)
6.1 ff) 13.3 b), 13.3 f) This relevant Essential
Requirement is not fully
addressed in this European
Standard
nd
6.1 ff) 13.6 (h)(2 paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
6.1 ff) 2) 13.2
6.1 ff) 3) 13.3 d), 13.5
6.1 ff) 4) 13.3 a) This relevant Essential
Requirement is not fully
addressed in this European
Standard
6.1 ff) 5) 13.3 k)
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
6.1 ff) 6) 13.3 c)
6.1 ff) 8) 13.3 m)
6.1 gg) 8.2, 12, 13.2, 13.3 i)
6.1 hh) 8.7
6.3 2, 10, 12.9
6.6 12.7.4
6.8.2 2, 9.1, 13
rd
6.8.2 7.5 (3 paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
6.8.2 d) 13.6 a), 13.6 h), 13.6 i)
6.8.2 aa) 1) 13.4
6.8.2 aa) 2) 13.6 c)
6.8.2 aa) 4), 6.8.2 aa) 5), 6.8.2 aa) 6) 12.2, 13.6 d)
6.8.2 aa) 7), 6.8.2 aa) 8) 12.2, 13.6 a)
6.8.2 aa) 9) 13.6 p)
6.8.2 aa) 10) 13.6 l)
6.8.2 aa) 11) 13.6 b)
6.8.2 aa) 12), 6.8.2 aa) 13), 6.8.2 aa) 14), 13.6 a)
6.8.2 aa) 15), 6.8.2 aa) 16), 6.8.2 aa) 17),
6.8.2 aa) 15), 6.8.2 aa) 18) 13.6 d)
6.8.3 2, 3, 9.1, 13
6.101 10.2
7.101 9.1, 12.8.1
10 4, 5, 9.2
19.4 12.6
36 9.2, 12.5
43 7.3, 9.3
44.3 7.6
44.7 8.1
44.8 7.1, 7.5
st
44.8 7.5 (1 paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
46 10.2
49.101 9.2, 12.2, 12.3
49.102 9.2
49.103 4, 9.2, 12.1
49.104 5, 9.2, 12.9
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
51.101 12.8.1. 12.8.2
51.102 4, 9.2, 12.8.1
51.103 4, 9.2, 12.8.1
51.104 6, 10.1, 12.4
51.105 12.4
51.106 10.1, 12.4, 12.8.2
51.107 12.4, 12.8.2
51.108 12.4, 12.8.2
51.109 10.1, 12.4, 12.8.2
52.5 2, 12.1
54.3 5, 9.2, 12.9
56.3 12.7.4
56.101 9.1, 12.8.1
56.102 9.1, 12.7.5
56.103 9.1, 10.1, 10.2
56.104 9.1, 10.1, 10.2
56.105 9.1, 10
57.3 2, 4, 12.1, 12.8.1
201.8.3 12.4, 12.8.2
201.12 5, 12.4
- 6a) This relevant Essential
Requirement is not addressed
in this European Standard
- 12.1a) This relevant Essential
Requirement is not addressed
in this European Standard.
- 13.6 (q) This relevant Essential
Requirement is not
addressed in this European
Standard
WARNING : Other requirements and other EU Directives may be applicable to the products falling within the
scope of this 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 European Standard
(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
- 1.1.4 This relevant EHSR is not
addressed in this European
Standard
6.1, 56 1.5.4 This relevant EHSR is not
fully addressed in this
European Standard
- 1.6.1 This relevant EHSR is not
addressed in this European
Standard
- 1.6.2 This relevant EHSR is not
addressed in this European
Standard
- 1.6.3 This relevant EHSR is not
addressed in this European
Standard
- 3.6.2 This relevant EHSR is not
addressed in this European
Standard
INTERNATIONAL ISO
STANDARD 10651-2
Second edition
2004-07-01
Lung ventilators for medical use —
Particular requirements for basic safety
and essential performance —
Part 2:
Home care ventilators for ventilator-
dependent patients
Ventilateurs pulmonaires à usage médical — Exigences particulières
pour la sécurité de base et les performances essentielles —
Partie 2: Ventilateurs pour soins à domicile pour patients dépendants

Reference number
ISO 10651-2:2004(E)
©
ISO 2004
ISO 10651-2:2004(E)
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ii © ISO 2004 – All rights reserved

ISO 10651-2:2004(E)
Contents Page
Foreword. vi
Introduction . vii
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 General requirements and requirements for tests . 3
5 Classification. 4
6 Identification, marking and documents. 4
6.1 Marking on the outside of equipment or equipment parts . 4
6.3 Marking of controls and instruments. 5
6.6 Identification of medical gas cylinders and connections. 5
6.8.2 Instructions for use. 6
6.8.3 Technical description. 7
6.101 Test method for legibility . 8
7 Power input. 8
7.101 Pneumatic power. 8
8 Basic safety categories . 8
9 Removable protective means . 9
10 Environmental conditions. 9
10.2.1 Environment. 9
10.2.2 Power supply. 9
10.101 Pneumatic driving-power supplies . 9
11 Not used. 9
12 Not used. 9
13 General. 9
14 Requirements related to classification . 10
14.2 * Class II Equipment . 10
15 Limitation of voltage and/or energy . 10
16 Enclosures and protective covers . 10
17 Separation. 10
18 Protective earthing, functional earthing and potential equalization . 10
19 Continuous leakage currents and patient auxiliary currents . 10
19.4 * Tests. 10
20 Dielectric strength. 10
21 Mechanical strength. 10
22 Moving parts. 11
23 Surfaces, corners and edges. 11
24 Stability in normal use. 11
25 Expelled parts. 11
ISO 10651-2:2004(E)
26 Vibration and noise.11
27 Pneumatic and hydraulic power .11
28 Suspended masses.11
29 X-radiation.11
30 Alpha, beta, gamma, neutron radiation and other particle radiation.11
31 Microwave radiation.11
32 Light radiation (including lasers).11
33 Infra-red-radiation.12
34 Ultraviolet radiation.12
35 Acoustical energy (including ultrasonics).12
36 Electromagnetic compatibility.12
37 Locations and basic requirements.12
38 Marking, accompanying documents .12
39 Common requirements for category AP and category APG equipment .12
40 Requirements and tests for category AP equipment, parts and components thereof .12
41 Requirements and tests for category APG equipment, parts and components thereof .12
42 Excessive temperatures.12
43 Fire prevention.13
43.2 * Oxygen-enriched atmospheres.13
43.101 Compatibility with pressurized oxygen.13
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.13
44.3 Spillage.13
44.7 Cleaning, sterilization and disinfection .13
44.8 Compatibility with substances used with the equipment .14
45 Pressure vessels and parts subject to pressure .14
46 Human errors.14
47 Electrostatic charges.14
48 Biocompatibility.14
49 Interruption of the power supply .14
49.101 *Internal electrical power source.15
49.102 Additional external backup power source.15
49.103 Spontaneous breathing during power failure .15
49.104 Accidental operation of the on/off-switch .15
50 Accuracy of operating data .15
51 Protection against hazardous output.16
51.101 Failure of air and oxygen supply systems.16
51.102 Adjustable ventilator breathing system pressure limitation .16
51.103 Maximum ventilator breathing system pressure limitation .16
51.104 Measurement of airway pressure .16
51.105 *High-inspiratory pressure alarm condition .16
51.106 Expiratory monitoring.17
51.107 Hypoventilation alarm condition.18
51.108 Continuing pressure alarm condition .18
51.109 Respiration-rate alarm condition.18
52 Abnormal operation and fault conditions.18
iv © ISO 2004 – All rights reserved

ISO 10651-2:2004(E)
53 Environmental tests. 19
54 General. 19
54.3 Protection against inadvertent adjustments. 19
55 Enclosures and covers. 19
56 Components and general assembly . 19
56.3 Connections — General . 19
56.101 Reservoir bags and breathing tubes. 21
56.102 Humidifiers and heat and moisture exchangers. 21
56.103 Pulse oximeters and capnometers. 21
56.104 Oxygen monitor and alarm condition . 21
56.105 Integrated monitoring equipment. 21
57 Mains parts, components and layout. 22
57.3 * Power supply cords . 22
58 Protective earthing — Terminals and connections . 22
59 Construction and layout. 22
101 Alarm systems. 22
201.8.3 Indication and access. 22
201.12 Alarm condition logging. 22
102 Appendices of IEC 60601-1:1988. 23
Annex AA (informative) Rationale. 24
Annex BB (informative) Reference to the essential principles. 28
Bibliography . 30

ISO 10651-2:2004(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 10651-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This second edition of ISO 10651-2, together with ISO 10651-6, cancels and replaces the first edition
(ISO 10651-2:1996), which has been technically revised.
ISO 10651 consists of the following parts, under the general title Lung ventilators for medical use — Particular
requirements for basic safety and essential performance:
 Part 2: Home care ventilators for ventilator-dependent patients
 Part 3: Particular requirements for emergency and transport ventilators
 Part 4: Particular requirements for operator-powered resuscitators
 Part 6: Home-care ventilatory support devices
The following part is under preparation:
 Part 5: Gas-powered emergency resuscitators
NOTE ISO 10651-1:1993, Lung ventilators for medical use — Part 1: Requirements, was withdrawn in 2001 and has
been revised as IEC 60601-2-12:2003, Medical electrical equipment — Part 2-12: Particular requirements for the safety of
lung ventilators — Critical care ventilators.
vi © ISO 2004 – All rights reserved

ISO 10651-2:2004(E)
Introduction
This part of ISO 10651 specifies requirements for lung ventilators intended mainly for home care use but
which could be used elsewhere (in healthcare facilities or other locations) for patients dependent on
ventilatory support i.e. where the ventilator is considered to be life-supporting equipment. These
ventilators will frequently be used in locations where driving power is not reliable. These ventilators will often
be supervised by non-healthcare personnel with varying levels of training.
This part of ISO 10651 is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991)
and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic standard for
the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the
general medical and patient environment; it also contains certain requirements for reliable operation to ensure
safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment,
such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The
Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency
surgical equipment, hospital beds, etc.
NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this part of ISO 10651, the following drafting conventions have been applied.
This part of ISO 10651 uses the same main clause titles and numbering as the General Standard, for ease of
cross-referencing of the requirements. The changes to the text of the General Standard, as supplemented by
the Collateral Standards, are specified by the use of the following words.
 “Replacement” means that the indicated clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
 “Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list
item, note, table, figure) additional to the General Standard.
 “Amendment” means that existing text of the General Standard is partially modified by deletion and/or
addition as indicated by the text of this Particular Standard.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this International Standard: clauses, subclauses, tables and figures are
numbered starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered
AA, BB, etc.
In this part of ISO 10651, the following print types are used:
 requirements, compliance with which can be verified, and definitions: roman type;
 notes and examples: smaller roman type;
 description of type of document change, and test methods: italic type;
 terms defined in the General Standard IEC 60601-1:1988, Clause 2 and terms defined in this Particular
Standard: bold type.
ISO 10651-2:2004(E)
Throughout this part of ISO 10651, text for which a rationale is provided in Annex AA is indicated by an
asterisk (*).
Requirements for ventilators intended for anaesthetic applications are given in ISO 8835-5.

viii © ISO 2004 – All rights reserved

INTERNATIONAL STANDARD ISO 10651-2:2004(E)

Lung ventilators for medical use — Particular requirements for
basic safety and essential performance —
Part 2:
Home care ventilators for ventilator-dependent patients
1 Scope
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment:
This part of ISO 10651 specifies requirements for lung ventilators intended for home applications for those
patients who are dependent on ventilatory support. Such ventilators are considered life-supporting
equipment, are frequently used in locations where driving power is not reliable, and are often supervised by
non-healthcare personnel with different levels of training.
This part of ISO 10651 is not applicable to cuirass and “iron-lung” ventilators.
This part of ISO 10651 is not applicable to ventilators intended only to augment the ventilation of
spontaneously breathing patients.
The requirements of this part of ISO 10651 which replace or modify the requirements of IEC 60601-1:1988
and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general
requirements.
2 Normative references
The following referenced documents are indispensable for the application 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.
ISO 32, Gas cylinders for medical use — Marking for identification of content
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-
bearing connectors
ISO 5359, Low-pressure hose assemblies for use with medical gases
ISO 5362, Anaesthetic reservoir bags
ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and vacuum
ISO 10651-2:2004(E)
ISO 8185, Humidifiers for medical use — General requirements for humidification systems, and Technical
Corrigendum 1:2001
ISO 9360-1, 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, 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 9919, Pulse oximeters for medical use — Requirements
ISO 14937, 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, and
Technical Corrigendum 1:2003
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied
ISO 21647, Medical electrical equipment — Particular requirements for the basic safety and essential
performance of respiratory gas monitors
IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety, and
Amendment 1:1991 and Amendment 2:1995
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility- Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for safety — Collateral
standard: Usability
IEC 60601-1-8:2003, Medical electrical equipment — Part 1-8: General requirements for safety — Collateral
standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and
medical electrical systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, IEC 60601-1:1988,
IEC 60601-1-8 and the following apply.
3.1
airway pressure
pressure at the patient connection port
3.2
* applied part
part of the equipment which in normal use
 necessarily comes into physical contact with the patient for the equipment to perform its function; or
 can be brought into contact with the patient; or
2 © ISO 2004 – All rights reserved

ISO 10651-2:2004(E)
 needs to be touched by the patient; or
 all parts of the ventilator intended to be connected to the ventilator breathing system
NOTE Adapted from IEC 60601-1/A2:1995, 2.1.5.
3.3
clearly legible
capable of being read by the operator or other relevant person with normal vision
3.4
home care ventilator for ventilator-dependent patient
ventilator
ventilator, suitable for domiciliary use without continuous professional supervision, intended to augment or
provide ventilation of the lungs of a patient who is dependent on this ventilation
NOTE 1 As this ventilator is intended to be applied to patients who are dependent on this ventilation, it is considered
to be life-supporting equipment.
NOTE 2 This term is hereinafter referred to as “ventilator”.
3.5
home care ventilatory support device for non-ventilator-dependent patient
ventilator, suitable for domiciliary use without continuous professional supervision, intended to augment or
provide ventilation of the lungs of a patient who is not dependent on this ventilation
NOTE This ventilatory support device is intended to be applied to patients who are not dependent on this
ventilation and will survive without this ventilatory support, without significant degradation in their health.
3.6
minute volume

V
volume of gas per minute entering or leaving the lungs of the patient
3.7
operator's position
intended position of the operator during normal use of the equipment
3.8
reserve electrical power source
part of the equipment that temporarily provides electrical power in the event of interruption of the primary
supply
4 General requirements and requirements for tests
IEC 60601-1:1988, Clause 3 and Clause 4 apply, except as follows.
3.1 *
Amendment (add at the end of the subclause):
This shall include all displayed values and calibrated controls over the environmental ranges specified in
10.2.1, as well as the combination of all accessories specified by the manufacturer in the instructions for use.
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.
ISO 10651-2:2004(E)
3.4
Amendment (add at the end of the subclause):
An equivalent degree of safety can be demonstrated by means of a risk analysis, in accordance with
ISO 14971.
5 Classification
IEC 60601-1:1988, Clause 5 applies, except as follows.
5.2
Amendment (add at the end of the subclause):
NOTE A ventilator can have applied parts of different types.
6 Identification, marking and documents
IEC 60601-1:1988, Clause 6, applies, except as follows:
6.1 Marking on the outside of equipment or equipment parts
Replacement:
e) Indication of origin
The name and address of the manufacturer and authorized representative, if applicable.
Amendment (add at the end of the list item):
j) Power input
The rated power input marking shall include the maximum rated power output available to the auxiliary
mains socket-outlets with which the ventilator is equipped.
Amendment (add at the end of the list item):
q) Physiological effects
If applicable, a warning that latex is used.
Addition:
aa) Any high-pressure 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 maximum flow requirements. If gas-specific colour-
coding of flow control or flexible hoses is used, it shall be in accordance with ISO 32.
bb) operator-accessible ports shall be marked. If symbols are used, they shall be explained in the
instructions for use and validated according to IEC 60601-1-6.
cc) Any particular storage and transport instructions.
dd) * Any particular warnings and/or precautions relevant to the immediate use of the ventilator.
EXAMPLE Those relevant after storage or transport outside the environmental conditions speci
...