SIST EN ISO 10651-2:2009

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)

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. 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 2: Heimbeatmungsgeräte für vom Gerät abhängige Patienten (ISO 10651-2:2004)

Dieser Teil von ISO 10651 legt Anforderungen für Beatmungsgeräte fest, die zur Verwendung bei der häuslichen Pflege von Patienten bestimmt sind, die von der Atemunterstützung abhängig sind. Diese Beatmungsgeräte werden als lebenserhaltende Geräte angesehen. Diese Beatmungsgeräte werden oft an Orten verwendet, an denen die Antriebsenergie nicht zuverlässig ist. Sie werden oft durch nichtmedizinisches Personal mit unterschiedlichen Ausbildungsgraden überwacht.
Dieser Teil von ISO 10651 gilt nicht für den Körper umschließende sowie in Form einer „Eisernen Lunge“ vorliegende Beatmungsgeräte.
Dieser Teil von ISO 10651 gilt nicht für Beatmungsgeräte, die nur dazu bestimmt sind, den Atmungsumfang spontan atmender Patienten zu vergrößern.
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 2: Ventilateurs pour soins à domicile pour patients dépendants (ISO 10651-2:2004)

L'ISO 10651-2:2004 spécifie les exigences relatives aux ventilateurs pulmonaires destinés aux applications à domicile par des patients qui dépendent d'une assistance respiratoire. Ces ventilateurs sont considérés comme un équipement vital, sont souvent utilisés dans des endroits où la fiabilité de la puissance motrice n'est pas assurée, et sont fréquemment supervisés par un personnel non médical ayant différents niveaux de formation.
L'ISO 10651-2:2004 n'est pas destinée à être utilisée avec la norme générale CEI 60601-1:1988.
L'ISO 10651-2:2004 n'est pas applicable aux ventilateurs de type cuirasse ou «poumon d'acier».
Les ventilateurs qui sont exclusivement destinés à augmenter la ventilation des patients qui respirent de manière spontanée sont exclus du domaine d'application de l'ISO 10651-2:2004.
Les exigences de l'ISO 10651-2:2004 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 - 2. del: Ventilatorji za oskrbo od aparata odvisnih pacientov na domu (ISO 10651-2:2004)

General Information

• Status: Withdrawn
• Publication Date: 14-Jun-2009
• Withdrawal Date: 01-Nov-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 30-Oct-2015
• Due Date: 22-Nov-2015
• Completion Date: 02-Nov-2015
• 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10651-2:2009 - 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)

Relations

• Replaced By: SIST EN ISO 80601-2-72:2015 - Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
• Effective Date: 01-Dec-2015
• Replaced By: SIST EN ISO 80601-2-72:2015 - Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 10651-2:2005 - 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)
• Effective Date: 01-Jul-2009
• Replaces: SIST EN ISO 10651-2:2005 - 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)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10651-2:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 10651-2:2005
3OMXþQLYHQWLODWRUML]DXSRUDERYPHGLFLQL3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLGHO9HQWLODWRUML]DRVNUERRGDSDUDWDRGYLVQLKSDFLHQWRYQD
GRPX,62
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
SIST EN ISO 10651-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10651-2:2009

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SIST EN ISO 10651-2:2009
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.

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SIST EN ISO 10651-2:2009
EN ISO 10651-2:2009 (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 10651-2:2009
EN ISO 10651-2:2009 (E)
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
EN ISO 10651-2:2009 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 10651-2:2004.
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.
3

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SIST EN ISO 10651-2:2009
EN ISO 10651-2:2009 (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) 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)
4

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SIST EN ISO 10651-2:2009
EN ISO 10651-2:2009 (E)
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
5

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SIST EN ISO 10651-2:2009
EN ISO 10651-2:2009 (E)
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.

6

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SIST EN ISO 10651-2:2009
EN ISO 10651-2:2009 (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 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

7

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SIST EN ISO 10651-2:2009

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SIST EN ISO 10651-2:2009


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

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SIST EN ISO 10651-2:2009
ISO 10651-2:2004(E)
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 10651-2:2009
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 2004 – All rights reserved iii

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SIST EN ISO 10651-2:2009
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

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SIST EN ISO 10651-2:2009
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 2004 – All rights reserved v

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SIST EN ISO 10651-2:2009
ISO 10651-2:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of nati
...