SIST EN ISO 10651-6:2005

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)

Es gilt IEC 60601-1:1988, Abschnitt 1 mit folgenden Ausnahmen:
Änderung:
Dieser Teil von ISO 10651 legt Anforderungen an die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale für Heimbeatmungsgeräte zur Atemunterstützung fest, die zur Verwendung bei der häuslichen Pflege von Patienten bestimmt sind, die aber auch an anderer Stelle (z. B. in Krankenhäusern) für Patienten verwendet werden können, bei denen ein Heimbeatmungsgeräte nach ISO 10651-2 nicht erforderlich ist.
Es ist davon auszugehen, dass die Anforderungen von diesem Teil von ISO 10651, die die Anforderungen von IEC 60601-1:1988 und ihrer Änderungen 1 (1991) und 2 (1995) ersetzen oder verändern, Vorrang vor den entsprechenden allgemeinen Anforderungen haben.

Ventilateurs pulmonaires a usage médical - Exigences particulieres pour la sécurité de base et les performances essentielles - Partie 6: Dispositifs d'assistance respiratoire a domicile (ISO 10651-6:2004)

Pljučni ventilatorji za uporabo v medicini – Posebne zahteve za osnovno varnost in bistvene lastnosti – 6. del: Ventilatorji in naprave za podporo pri dihanju pacientov v oskrbi na domu (ISO 10651-6:2004)

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-2004
• Withdrawal Date: 18-May-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 19-May-2009
• Due Date: 11-Jun-2009
• Completion Date: 19-May-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10651-6:2004 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

Relations

• Replaced By: SIST EN ISO 10651-6:2009 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
• Effective Date: 01-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10651-6:2005
01-januar-2005
3OMXþQLYHQWLODWRUML]DXSRUDERYPHGLFLQL±3RVHEQH]DKWHYH]DRVQRYQRYDUQRVW
LQELVWYHQHODVWQRVWL±GHO9HQWLODWRUMLLQQDSUDYH]DSRGSRURSULGLKDQMX
SDFLHQWRYYRVNUELQDGRPX,62
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 a usage médical - Exigences particulieres pour la sécurité de
base et les performances essentielles - Partie 6: Dispositifs d'assistance respiratoire a
domicile (ISO 10651-6:2004)
Ta slovenski standard je istoveten z: EN ISO 10651-6:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-6:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005


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

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SIST EN ISO 10651-6:2005
ISO 10651-6:2004(E)
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©  ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 10651-6:2005
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
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SIST EN ISO 10651-6:2005
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
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SIST EN ISO 10651-6:2005
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 2004 – All rights reserved v

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SIST EN ISO 10651-6:2005
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.
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SIST EN ISO 10651-6:2005
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.
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SIST EN ISO 10651-6:2005
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

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SIST EN ISO 10651-6:2005
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
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SIST EN ISO 10651-6:2005
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.
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SIST EN ISO 10651-6:2005
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.
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SIST EN ISO 10651-6:2005
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.
Amendme
...