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)

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.

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 Gesundheitseinrichtungen)
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 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)

L'ISO 10651-6:2004 spécifie les exigences fondamentales en matière de sécurité et de performance essentielle pour les dispositifs d'assistance respiratoire à domicile, destinés principalement à être utilisés dans le cadre des soins à domicile mais qui pourraient être utilisés ailleurs (par exemple dans des hôpitaux) pour des patients appropriés lorsque l'utilisation d'un ventilateur de soins à domicile conforme à l'ISO 10651-2 n'est pas nécessaire.Elle est destinée à être utilisée conjointement avec la norme générale CEI 60601-1:1988.
Les exigences de l'ISO 10651-6:2004 qui remplacent ou modifient les exigences de la CEI 60601-1:1988 et ses Amendements 1 (1991) et 2 (1995) sont destinés à avoir la priorité sur les exigences générales correspondantes.

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: 14-Jun-2009
• Withdrawal Date: 31-Aug-2020
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 25-Aug-2020
• Due Date: 17-Sep-2020
• Completion Date: 01-Sep-2020
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 10651-6:2009 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

Relations

• Replaced By: SIST EN ISO 80601-2-80:2019 - Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)
• Effective Date: 30-Oct-2019
• Replaced By: SIST EN ISO 80601-2-79:2019 - Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)
• Effective Date: 30-Oct-2019
• Replaces: 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)
• Effective Date: 01-Jul-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10651-6:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 10651-6:2005
3OMXþQLYHQWLODWRUML]DXSRUDERYPHGLFLQL3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLGHO9HQWLODWRUMLLQQDSUDYH]DSRGSRURSULGLKDQMXSDFLHQWRY
YRVNUELQDGRPX,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 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
SIST EN ISO 10651-6:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10651-6:2009

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SIST EN ISO 10651-6:2009
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.

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SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC .4

2

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SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (E)
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
EN ISO 10651-6:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
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.
3

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SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (E)
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)
4

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SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (E)
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
5

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SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (E)
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.
6

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SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (E)

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


7

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SIST EN ISO 10651-6:2009

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SIST EN ISO 10651-6:2009


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 10651-6:2009
ISO 10651-6:2004(E)
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All rights reserved. Unless otherwise specified, 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 either ISO at the address below or
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 10651-6:2009
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 2004 – All rights reserved iii

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SIST EN ISO 10651-6:2009
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

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SIST EN ISO 10651-6:2009
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 10651-6:2009
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

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SIST EN ISO 10651-6:2009
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), hereaft
...