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CEN

EN ISO 10651-6:2004

(Main)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (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)

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 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)

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Withdrawn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
30-Jun-2004
Withdrawal Date
07-Apr-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
08-Apr-2009
Completion Date
08-Apr-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
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)

Relations

Replaced By
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
15-Apr-2009

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Standards Content (Sample)


SLOVENSKI STANDARD
01-januar-2005
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LQELVWYHQHODVWQRVWL±GHO9HQWLODWRUMLLQQDSUDYH]DSRGSRURSULGLKDQMX
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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 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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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©  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,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
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 aga
...

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This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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