SIST EN ISO 17510-1:2008
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment (add at the end of the Subclause 1.1): This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions. This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates. Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510. This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including: - ISO 10651-2:2004; - ISO 10651-3:1997; - ISO 10651-4:2002; - ISO 10651-5:2006; - ISO 10651-6:2004. This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12. ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also Figure AA.1.
Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe-Atemtherapiegeräte (ISO 17510-1:2007)
IEC 60601 1:1988, Abschnitt 1, gilt mit folgender Ausnahme:
Änderung (am Ende des Unterabschnitts 1.1 ergänzen):
Dieses Dokument legt Anforderungen an Geräte fest, die für die Schlafapnoe Atemtherapie im häuslichen Bereich, in Schiffen, Luftfahrzeugen und anderen Transportfahrzeugen und in Einrichtungen des Gesundheitswesens vorgesehen sind.
Dieses Dokument gilt für zum Gebrauch bei Erwachsenen und Kindern vorgesehene Geräte und schließt für die Anwendung bei Neugeborenen vorgesehene Geräte aus.
Jet und Hochfrequenzbeatmung und Oszillation werden in diesem Teil dieses Dokuments nicht berücksichtigt.
Dieses Dokument trifft nicht auf Geräte zu, die im Anwendungsbereich der Normenreihe ISO 10651 liegen, einschließlich:
- 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 3:1997, Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators;
- ISO 10651 4:2002, Lung ventilators — Part 4: Particular requirements for operator powered resucitators;
- ISO 10651 5:2005, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas powered emergency resuscitators; und
- ISO 10651 6:2005, Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home care ventilatory support devices.
Dieses Dokument behandelt keine Geräte, die in den Anwendungsbereich von IEC 60601 2 12:2001, Medical electrical equipment — Part 2 12: Particular requirements for the safety of lung ventilators — Critical care ventilators, fallen.
Masken und Anwendungszubehör einschließlich Atemschläuche werden in Teil 2 dieses Dokuments behandelt.
Thérapie respiratoire de l'apnée du sommeil - Partie 1: Equipements de thérapie respiratoire de l'apnée du sommeil (ISO 17510-1:2007)
Zdravljenje dihanja pri prenehanju dihanja v spanju - 1. del: Oprema za zdravljenje prenehanja dihanja v spanju (ISO 17510-1:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 17510-1:2008
01-april-2008
1DGRPHãþD
SIST EN ISO 17510-1:2002
SIST EN ISO 17510-1:2002/AC:2004
Zdravljenje dihanja pri prenehanju dihanja v spanju - 1. del: Oprema za zdravljenje
prenehanja dihanja v spanju (ISO 17510-1:2007)
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment
(ISO 17510-1:2007)
Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe-Atemtherapiegeräte (ISO 17510-
1:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 1: Equipements de thérapie
respiratoire de l'apnée du sommeil (ISO 17510-1:2007)
Ta slovenski standard je istoveten z: EN ISO 17510-1:2007
ICS:
11.040.10
SIST EN ISO 17510-1:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 17510-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2007
ICS 11.040.10 Supersedes EN ISO 17510-1:2002
English Version
Sleep apnoea breathing therapy - Part 1: Sleep apnoea
breathing therapy equipment (ISO 17510-1:2007)
Thérapie respiratoire de l'apnée du sommeil - Partie 1: Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe-
Équipement de thérapie respiratoire de l'apnée du sommeil Atemtherapiegeräte (ISO 17510-1:2007)
(ISO 17510-1:2007)
This European Standard was approved by CEN on 30 September 2007.
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: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17510-1:2007: E
worldwide for CEN national Members.
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EN ISO 17510-1:2007 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC .4
2
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EN ISO 17510-1:2007 (E)
Foreword
This document (EN ISO 17510-1:2007) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment" in collaboration with 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 April 2008, and conflicting national standards shall be withdrawn at the
latest by April 2008.
This document supersedes EN ISO 17510-1:2002.
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(s).
For relationship with EC Directive(s), 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 17510-1:2007 has been approved by CEN as a EN ISO 17510-1:2007 without any
modification.
3
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EN ISO 17510-1:2007 (E)
Annex ZA
(informative)
Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC
This Document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices (Medical Device Directive).
Once this document 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
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Corresponding essential Qualifying remarks/Notes
this document requirement of Directive 93/42/EEC
All 1, 2, 3
4 6, 12.6
6 13
6.1 2, 13.3 a)
6.1 aa) to cc) 13.6 c), d)
6.1 dd) 8.7, 9.1, 13.3, 13.4, 13.5
6.3 10.2, 10.3, 12.9
6.8.2 13.6 b), c), h), i), l)
6.8.3 13.6 c), d), p), n)
10.1 8.3
10.101, 10.102 4
13, 15, 17, 18,19, 20 12.6
21 5, 9.2, 12.7.1
23 4, 9.2
24 4, 12.7.1
26 12.7.2, 12.7.3
36 4, 9.2, 11.3.1, 12.5
38 13.2, 13.4
39, 40, 41 9.3
4
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EN ISO 17510-1:2007 (E)
42 9.2, 12.7.5
43 7.1, 7.2, 9.3
43.101 7.1, 9.3
44 4, 7.2, 7.3, 7.5, 7.6, 8.1, 8.6
44.6 7.6
44.7 8.3, 8.5
46 9.2, 10.2, 12.8.2, 12.9
48 7.2, 7.5
49 4
49.101 12.8.1, 12.8.2
51 12.8.1, 12.8.2
51.5 2, 12.8.2, 12.9
51.101 12.8.2
51.102 10.1, 10.2, 12.8.2
51.103 10.1, 10.2, 12.8.2
51.104 4, 12.8.1, 12.8.2
51.105 4, 12.8.2
52 12.1
54.1 12.1, 12.9
54.101 7.5
56.3 9.1, 12.7.4
56.10 12.9
56.101.1 7.3, 8.1, 8.4
56.101.2 7.3, 8.1, 8.6
56.102 9.1
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International standard.
5
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INTERNATIONAL ISO
STANDARD 17510-1
Second edition
2007-10-01
Sleep apnoea breathing therapy —
Part 1:
Sleep apnoea breathing therapy
equipment
Thérapie respiratoire de l'apnée du sommeil —
Partie 1: Équipement de thérapie respiratoire de l'apnée du sommeil
Reference number
ISO 17510-1:2007(E)
©
ISO 2007
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ISO 17510-1:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 17510-1:2007(E)
Contents Page
Foreword. v
Introduction . vi
1 * Scope. 1
2 Normative references. 1
3 Terms and definitions. 3
4 Requirements. 4
5 Classification and designation. 4
6 Marking, labelling and packaging . 4
7 Power input. 8
8 Basic safety categories. 8
9 Removable protective means . 8
10 Environmental conditions. 8
11 Not used. 9
12 Not used. 9
13 General. 9
14 Requirements related to classification. 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. 9
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
26 * Vibration and noise . 10
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) . 12
33 Infra-red radiation . 12
© ISO 2007 – All rights reserved iii
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ISO 17510-1:2007(E)
34 Ultra-violet radiation . 12
35 Acoustical energy (including ultra-sonics) . 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 . 13
42 Excessive temperatures. 13
43 Fire prevention . 13
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection . 13
45 Pressure vessels and parts subject to pressure . 14
46 Human errors. 14
47 Electrostatic charges. 14
48 Biocompatibility . 15
49 Interruption of the power supply. 15
50 Accuracy of operating data. 15
51 Protection against hazardous output . 15
52 Abnormal operation and fault conditions. 16
53 Environmental tests. 16
54 General. 16
55 Enclosures and covers. 17
56 Components and general assembly . 17
57 Mains parts, components and layout. 19
58 Protective earthing — Terminals and connections . 19
59 Construction and layout. 19
Annex AA (informative) Rationale. 20
Annex BB (normative) * Pressure accuracy in normal use test methods . 25
Annex CC (normative) Maximum flowrate test method. 27
Annex DD (informative) Environmental aspects . 28
Annex EE (informative) Reference to the essential principles . 30
Annex FF (informative) Terminology – Alphabetized index of defined terms. 32
Bibliography . 34
iv © ISO 2007 – All rights reserved
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ISO 17510-1:2007(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 17510-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This second edition cancels and replaces the first edition (ISO 17510-1:2002) which has been technically
revised.
ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing therapy:
⎯ Part 1: Sleep apnoea breathing therapy equipment
⎯ Part 2: Masks and application accessories
© ISO 2007 – All rights reserved v
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ISO 17510-1:2007(E)
Introduction
Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep.
The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As a result,
the use of sleep apnoea breathing therapy equipment has become common. This document covers basic
safety and essential performance requirements needed to protect patients in the use of this equipment.
This document 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 document for the
safety of 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 electrical 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 Standard can be found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this document, the following drafting conventions have been applied.
This document 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 document.
⎯ “Addition” means that the relevant text of this document is supplementary to the requirements of the
General Standard.
⎯ “Amendment” means that existing text of the General Standard is modified as indicated by the text of this
document.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this document: 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.
Throughout this document, text for which a rationale is provided in Annex AA is indicated by an asterisk (*).
vi © ISO 2007 – All rights reserved
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INTERNATIONAL STANDARD ISO 17510-1:2007(E)
Sleep apnoea breathing therapy —
Part 1:
Sleep apnoea breathing therapy equipment
1 * Scope
IEC 60601-1:1988, Clause 1 applies, except as follows.
Amendment (add at the end of the Subclause 1.1):
This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for
domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.
This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes
equipment intended for use with neonates.
Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.
This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including:
⎯ ISO 10651-2:2004;
⎯ ISO 10651-3:1997;
⎯ ISO 10651-4:2002;
⎯ ISO 10651-5:2006;
⎯ ISO 10651-6:2004.
This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12.
ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks
and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also
Figure AA.1.
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 — Colour coding
ISO 3744:1994, Acoustics — Determination of sound power levels of noise sources using sound pressure —
Engineering method in an essentially free field over a reflecting plane
© ISO 2007 – All rights reserved 1
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ISO 17510-1:2007(E)
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 4871, Acoustics — Declaration and verification of noise emission values of machinery and equipment
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 8185:2007, Respiratory tract humidifiers for medical use — Particular requirements for respiratory
humidification systems
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed
medical gases and vacuum
ISO 11135 (both parts), Sterilization of health care products — Ethylene oxide
ISO 11137 (all parts), Sterilization of health care products — Radiation
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
ISO 14971:2007, Medical devices — Application of risk management to medical devices; Amendment 1, 2003
ISO 15223-1:2007, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO/TR 16142:2006, Medical devices — Guidance on the selection of standards in support of recognized
essential principles of safety and performance of medical devices
ISO 17510-2:2007, Sleep apnoea breathing therapy — Part 2: Masks and application accessories
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
ISO 17665 (both parts), Sterilization of health care products — Moist heat
ISO 23328-1, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to
assess filtration performance
ISO 23328-2, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature; Amendment 1, 1995
IEC 60529, Degrees of protection provided by enclosures (IP Code); Amendment 1:1999
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety and essential
performance; Amendment A1:1991; Amendment A2:1995
IEC 60601-1-1:2000, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral
Standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral Standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance — Collateral standard: Usability
2 © ISO 2007 – All rights reserved
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ISO 17510-1:2007(E)
IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral Standard: General requirements tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
IEC 61672 (all parts), Electroacoustics — Sound level meters
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, ISO 14971, ISO 17510-2,
ISO 23328-2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and the following apply.
NOTE For convenience, the sources of all defined terms used in this document are given in Annex FF.
3.1
* 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
⎯ is intended to be connected to the patient connection port of the sleep apnoea breathing therapy
equipment
[Modified from IEC 60601-1/A2:1995, definition 2.1.5]
3.2
bi-level positive airway pressure
two therapeutic
...
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