EN ISO 10651-6:2009

SLOVENSKI STANDARD
01-julij-2009
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SIST EN ISO 10651-6:2005
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Lung ventilators for medical use - Particular requirements for basic safety and essential
performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die
grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 6:
Heimbeatmungsgeräte zur Atemunterstützung (ISO 10651-6:2004)
Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de
base et les performances essentielles - Partie 6: Dispositifs d'assistance respiratoire à
domicile (ISO 10651-6:2004)
Ta slovenski standard je istoveten z: EN ISO 10651-6:2009
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 10651-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 10651-6:2004
English Version
Lung ventilators for medical use - Particular requirements for
basic safety and essential performance - Part 6: Home-care
ventilatory support devices (ISO 10651-6:2004)
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 6: Dispositifs d'assistance respiratoire einschließlich der wesentlichen Leistungsmerkmale - Teil 6:
à domicile (ISO 10651-6:2004) Heimbeatmungsgeräte zur Atemunterstützung (ISO 10651-
6:2004)
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 10651-6:2009: 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 10651-6:2004 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 10651-6:2004.
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 10651-6:2004 has been approved by CEN as a EN ISO 10651-6:2009 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) Qualifying remarks/Notes
of 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) 13.3 k)
6.1 aa), 6.1 bb) 13.2
6.1 cc) 13.3i)
6.1 dd) 13.3 i), 13.6 k)
6.1 ee) 13.3 e)
6.1 ff) 13.3 b), 13.3 f)
6.1 ff) 13.3 (f) 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)
6.1 ff) 5) 13.3 k)
6.1 ff) 6) 13.3 c)
6.1 ff) 8) 13.3 m)
6.1 gg) 12.8.2, 13.2, 13.3 i)
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 93/42/EEC
6.1 hh) 8.7
6.3 2, 10, 12.9
6.6 12.7.4
rd
6.8 7.5 (3 paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
6.8.2 2, 9.1, 13
6.8.2 d) 13.6 a), 13.6 h), 13.6 i)
nd
6.8.2 d) 13.6 (h)(2 paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
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) 15), 6.8.2 aa) 17) 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
43.2 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 12.2
49.102 4, 9.2, 12.1
49.103 5, 9.2, 12.9
51.101 4, 9.2
51.102 6, 10.1
51.103 10.1, 12.4, 12.8.2
51.104 10.1. 12.4
51.105 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
57.3 2, 4, 12.1, 12.8.1
Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) Qualifying remarks/Notes
of Directive 93/42/EEC
101 12.4, 12.8.2
- 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 o 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 10651-6
First edition
2004-07-01
Lung ventilators for medical use —
Particular requirements for basic safety
and essential performance —
Part 6:
Home-care ventilatory support devices
Ventilateurs pulmonaires à usage médical — Exigences particulières
pour la sécurité de base et les performances essentielles —
Partie 6: Dispositifs d'assistance respiratoire à domicile

Reference number
ISO 10651-6:2004(E)
©
ISO 2004
ISO 10651-6:2004(E)
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ii © ISO 2004 – All rights reserved

ISO 10651-6:2004(E)
Contents Page
Foreword . vi
Introduction . vii
1 Scope . 1
2 Normative references. 1
3 Terms and definitions . 2
4 General requirements and general requirements for tests. 3
5 Classification . 3
6 Identification, marking and documents. 3
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
6.101 Test method for legibility. 7
7 Power input . 8
7.101 Pneumatic power. 8
8 Basic safety categories. 8
9 Removable protective means. 8
10 Environmental conditions. 8
10.101 Pneumatic driving power supplies .9
11 Not used . 9
12 Not used . 9
13 General. 9
14 Requirements related to classification.9
14.2 * Class II Equipment. 9
15 Limitation of voltage and/or energy. 9
16 Enclosures and protective covers . 9
17 Separation . 9
18 Protective earthing, functional earthing and potential equalization . 9
19 Continuous leakage currents and patient auxiliary currents. 10
19.4 * Tests. 10
20 Dielectric strength . 10
21 Mechanical strength. 10
22 Moving parts . 10
23 Surfaces, corners and edges . 10
24 Stability in normal use . 10
25 Expelled parts . 10
ISO 10651-6:2004(E)
26 Vibration and noise.10
27 Pneumatic and hydraulic power.10
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 .11
34 Ultra-violet radiation .11
35 Acoustical energy (including ultrasonics) .11
36 Electromagnetic compatibility.11
37 Locations and basic requirements.11
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 .12
43.2 Oxygen enriched atmospheres .12
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.13
45 Pressure vessels and parts subject to pressure.13
46 Human errors.14
47 Electrostatic charges.14
48 Biocompatibility .14
49 Interruption of the power supply.14
49.101 * Internal electrical power source.14
49.102 Spontaneous breathing during power failure .14
49.103 Accidental operation of the on/off-switch.15
50 Accuracy of operating data.15
51 Protection against hazardous output .15
51.101 Maximum ventilator breathing system pressure limitation.15
51.102 Measurement of airway pressure.15
51.103 * High-inspiratory pressure alarm condition .15
51.104 Expiratory monitoring .15
51.105 Respiration rate alarm condition.16
iv © ISO 2004 – All rights reserved

ISO 10651-6:2004(E)
52 Abnormal operation and fault conditions . 17
53 Environmental tests . 17
54 General. 17
54.3 Protection against inadvertent adjustments. 17
55 Enclosures and covers . 17
56 Components and general assembly. 17
56.3 Connections — General. 17
56.101 Reservoir bags and breathing tubes . 19
57 Mains parts, components and layout . 19
57.3 * Power supply cords. 19
58 Protective earthing — Terminals and connections. 19
59 Construction and layout . 20
101 Alarm systems . 20
102 Appendices of IEC 60601-1:1988 . 20
Annex AA (informative) Rationale. 21
Annex BB (informative) Reference to the Essential Principles . 25
Bibliography . 26

ISO 10651-6:2004(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 10651-6 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This first edition of ISO 10651-6, together with the second edition of ISO 10651-2, cancels and replaces the
first edition of 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 10651-6:2004(E)
Introduction
This part of ISO 10651 specifies requirements for ventilatory support devices mainly for home-care use but
which could be used elsewhere (in healthcare facilities or other locations) for patients not dependent on
ventilatory support, i.e. where the ventilator is not considered to be life-supporting equipment. These
ventilators are frequently used in locations where driving power is not reliable. These ventilators often are
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 Standards 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 an existing element 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 part of ISO 10651: 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 part of
ISO 10651: bold type.
ISO 10651-6:2004(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 10651-6:2004(E)

Lung ventilators for medical use — Particular requirements for
basic safety and essential performance —
Part 6:
Home-care ventilatory support devices
1 Scope
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment:
This part of ISO 10651 specifies the basic safety and essential performance requirements for home-care
ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in
healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with
ISO 10651-2 is not required.
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 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 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 10651-6:2004(E)
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied
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 60601-1-2:2001, 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 (at present Commmittee draft)
IEC 60601-1-8:2003, Medical electrical equipment — Part 1-8: General requirements for safety — Collateral
standard: Alarm systems — Requirements, tests and guidelines — General requirements and guidelines 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 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
 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, 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 As this ventilator is intended to be applied to patients who are dependent on this ventilation, it is considered
to be life-supporting equipment.
2 © ISO 2004 – All rights reserved

ISO 10651-6:2004(E)
3.5
home-care ventilatory support device for non-ventilator-dependent patients
ventilator
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 1 This ventilator 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.
NOTE 2 This term is hereinafter referred to as “ventilator”.
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 in normal use of the equipment
4 General requirements and general 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.
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
Additon (add at the end of the subclause):
NOTE A ventilator may have applied parts of different types.
6 Identification, marking and documents
IEC 60601-1:1988, Clause 6, applies, except as follows.
ISO 10651-6:2004(E)
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)]:
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)]:
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 32:1977.
bb) Operator-accessible ports shall be marked. If symbols are used, they shall be explained in the
instructions for use and validated in accordance with 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 After storage or transport outside the environmental conditions specified for use.
ee) Where appropriate, the date after which the safe operation of the ventilator or accessory, when used for
the first time, is not assured, expressed as the year and month. Symbol 3.12 from ISO 15223:2000 may be
used.
ff) Packages containing breathing attachments shall be clearly marked with the following, as far as applicable:
1) a description of the contents;
2) an identification reference to the type, or Symbol 3.13 from ISO 15223:2000;
3) an identification reference to the batch or serial number, or Symbol 3.14 or 3.16 from
ISO 15223:2000;
4) the name or trademark and address of the manufacturer, supplier, and authorized representative;
5) packages containing latex shall be clearly marked with the word ‘LATEX’;
6) the word “STERILE”, or Symbols 3.20 to 3.24 from ISO 15223:2000;
7) the words “SINGLE USE ONLY”, “DO NOT REUSE”, or Symbol 3.2 from ISO 15223:2000;
gg) All flow-direction-sensitive components that are operator-removable without the use of a tool shall be
durably and legibly marked with an arrow indicating the direction of the flow.
4 © ISO 2004 – All rights reserved

ISO 10651-6:2004(E)
hh) Device packaging and/or labelling shall differentiate between sterile and non-sterile versions of the same
or similar products placed on the market by the same manufacturer [see 6.1 ff) 6].
6.3 Marking of controls and instruments
Amendment [add at the end of the list item g)]:
g)
Airway pressures shall be marked in both an SI unit and centimetre water column (cm H O).
Addition:
aa) Visual displays shall be visible and clearly legible.
Amendment (add at the end of the compliance test):
and the legibility test of 6.101.
6.6 Identification of medical gas cylinders and connections
Replacement:
If gas-specific colour-coding is used (e.g. for flow controls, flexible hoses, gas cylinders, etc.) it shall be in
accordance with ISO 32. See also 56.3 aa).
6.8.2 Instructions for use
Amendment [add at the end of the list item d)]:
d) Cleaning, disinfection and sterilization of parts in contact with the patient
If applicable, the instructions for use shall contain
 information about cleaning and sterilization prior to first use,
 information about cleaning, disinfection and sterilization and any restriction concerning re-use,
 instructions which indicate the maximum number of reprocessing cycles of cleaning, disinfection and
sterilization before a component can no longer be used, or instructions which indicate the visual or
functional pass/fail criteria to be used in determining when a component can no longer be used after
reprocessing.
Additions:
aa) Additional general information
The instructions for use shall include the following:
1) the intended use of the ventilator;
2) description of operator-accessible ports. See also 6.1 bb) and 56.3 dd);
3) the rated supply range and consumption that is required for normal use of the ventilator (see also
49.101 e.g. voltage, current, pressure, flow);
4) information necessary to ensure that the ventilator is installed correctly and is in safe and correct
working order;
ISO 10651-6:2004(E)
5) a method for testing the function of the alarm system for each possible alarm condition and a
recommendation for the interval of testing;
6) if the ventilator is provided with a reserve power supply,
 how to determine the status of the reserve power source,
 how the reserve power source can be tested, and
 the functioning after a switchover to the reserve power supply.
7) * the ampere-hour rating of the internal electrical power source and the operational time after it
has become fully charged;
8) if the ventilator has provision for an external reserve electrical power source (see 49.101 and
49.102),
 the rated voltage range requirement,
 the nominal voltage range, and
 the maximum current requirement.
9) for each control and measured variable provided on the ventilator, a listing of the applicable range,
resolution and accuracy (see also Cla
...