EN ISO 17510-1:2009

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 17510-1:2008
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: Équipement de thérapie
respiratoire de l'apnée du sommeil (ISO 17510-1:2007)
Ta slovenski standard je istoveten z: EN ISO 17510-1:2009
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.

EUROPEAN STANDARD
EN ISO 17510-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 17510-1:2007
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 24 February 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 17510-1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
The text of ISO 17510-1:2007 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
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 September 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 17510-1:2007.
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 17510-1:2007 has been approved by CEN as a EN ISO 17510-1:2009 without any
modification.
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 - Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
All 1, 2, 3
4 6, 12.6
- 6a
This relevant Essential Requirement is
not addressed in this European
Standard
6 13
6 13.6 (h)(2nd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 13.6 (q) This relevant Essential Requirement is
not addressed in this European
Standard
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
6.1 dd) 7th dash 13.3 (f) 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
6.3 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
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 7.5 (1st paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
54 7.5 (2nd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 7.5 (3rd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 12.1a) This relevant Essential Requirement is
not addressed in this European
Standard.
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
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 EHSR o 2006/42/EC Qualifying remarks/Notes
EN
- 1.1.4 This relevant EHSR is not addressed in
this European Standard
6.8.2, 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
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International standard.

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
ISO 17510-1:2007(E)
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ii © ISO 2007 – All rights reserved

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 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

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 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

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 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

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 positive pressure levels at the patient connection port during the respiratory cycle
3.3
breathing gas pathway
pathway through which gas flows at respiratory pressures between the fresh-gas intake port and the patient
connection port
3.4
continuous positive airway pressure
CPAP
therapeutic continuous positive airway pressure at the patient connection port during the respiratory cycle
3.5
pressure accuracy
difference between the pressure set on the sleep apnoea breathing therapy equipment and the pressure
measured at the patient connection port
3.6
self-adjusting
automatically adjusting the pressure in the breathing gas pathway according to the patient's needs during use
3.7
sleep apnoea breathing therapy equipment
equipment intended to alleviate the symptoms of patients who suffer from sleep apnoea by delivering a
therapeutic breathing pressure to the patient
NOTE Sleep apnoea breathing therapy equipment is primarily used without direct professional supervision when a
patient is at home.
ISO 17510-1:2007(E)
4 Requirements
IEC 60601-1:1988, Clauses 3 and 4 apply.
5 Classification and designation
IEC 60601-1:1988, Clause 5 applies.
6 Marking, labelling and packaging
IEC 60601-1:1988, Clause 6 applies, except as follows.
6.1 Marking on the outside of equipment or equipment parts
e) Identification of the origin
Replacement:
The address and name or trade-mark of the manufacturer or supplier or of the authorized representative of the
manufacturer who claims that the equipment complies with this document.
Addition:
aa) Flow-direction sensitive components
All operator-interchangeable flow-direction sensitive components shall be permanently marked with a clearly
legible arrow indicating the correct direction of flow.
bb) High-pressure input port
Any high-pressure input port shall be marked on or in the vicinity with the name or symbol of the gas as given
in ISO 5359 with the rated range of supply pressures in kilopascals and with the maximum flowrate
requirement in litres per minute.
cc) Operator-accessible ports
If an operator-accessible port is provided, it shall be marked. Appropriate pictograms or symbols may be used.
dd) * Label of the equipment or detachable parts
The label shall contain the following:
⎯ if the intended purpose of the equipment is not obvious to the operator, the detachable part or its package
shall be provided with an instruction leaflet or operating instructions;
⎯ the name or trade name and address of the manufacturer and the name and address of the person
responsible or of the authorized representative of the manufacturer or importer;
⎯ equipment identification and content information;
⎯ where appropriate, symbols 5.20 to 5.24 from ISO 15223-1:2007;
⎯ where appropriate, an identification reference to the batch or serial number, or symbols 5.14 or 5.16 from
ISO 15223-1:2007;
4 © ISO 2007 – All rights reserved

ISO 17510-1:2007(E)
⎯ where appropriate, an indication of the latest date by which the equipment can be used, expressed as the
year and month;
⎯ where appropriate, an indication that the equipment is for single or multiple patient use only;
⎯ any special storage and/or handling conditions;
⎯ any warning and/or precaution to take;
⎯ equipment which is considered to constitute active medical devices, year of manufacture or symbol 5.13
from ISO 15223-1:2007, except those covered by 6.1 dd) 6th dash;
NOTE This indication can be included in the batch code or serial number.
⎯ where applicable, recommended methods of cleaning and disinfection or cleaning and sterilization shall
be specified;
⎯ where applicable, use of an appropriate breathing system filter shall be specified;
⎯ where applicable, methods of cleaning the breathing system filter shall be specified;
⎯ equipment packaging and/or labelling shall differentiate between the same or similar products placed on
the market, both sterile and non-sterile;
⎯ for equipment and its parts, marking regarding their proper disposal;
⎯ if provided, gas-specific colour-coding of flowrate controls and flexible hoses in accordance with ISO 32.
6.2 Marking of controls and instruments
g)
Amendment (add at the end of the list):
Airway pressures shall be marked in both an SI unit and centimetre water (cm H O). The units of measure
may be selectable.
6.8.2 Instructions for use
Amendment (add at the end of the list item):
d) * Cleaning, disinfection and sterilization of parts in contact with the patient
If applicable, the instructions for use shall contain:
⎯ information about cleaning and disinfection or sterilization of equipment and accessories prior to first use;
⎯ information about cleaning and disinfection or cleaning and sterilization and any restriction concerning
re-use, including any specific procedure(s) necessary before the equipment and accessories are
transferred to another patient;
⎯ instructions that indicate the maximum number of reprocessing cycles of cleaning, disinfection and
sterilization before a component can no longer be used, or instructions that indicate the visual or
functional pass/fail criteria to be used in determining when a component can no longer be used after
reprocessing.
ISO 17510-1:2007(E)
Addition:
aa) The instructions for use shall additionally include the following:
⎯ the form and the dimensions of the patient connection port [see 56.3 ee)];
⎯ * the maximum flowrate at pressures of the minimum, ¼, ½, ¾ and the maximum of adjustable pressure
(rounded up to the next whole integer) under the conditions specified in Annex CC, expressed in tabular
form (see Table CC.1);
⎯ pressure accuracy under the static long-term and dynamic short-term conditions derived from the tests as
specified in BB.1 and BB.2;
NOTE This information is expressed in tabular form.
⎯ for equipment with an integrated humidifier, all results shall be given with the humidifier filled halfway
between the minimum and maximum and operating in normal use;
⎯ for equipment that is recommended for use with a humidifier, all results shall be given without a
humidifier as well as with any humidifier recommended in the instructions for use, filled halfway
between the minimum and maximum and operating in normal use.
⎯ unless not applicable, a warning to the effect that appropriate masks and accessories must be used with
the equipment to ensure the delivery of the therapeutic pressure and to minimize CO rebreathing;
⎯ information concerning the disposal of the equipment and components (e.g. battery).
bb) The maximum achievable pressure at the patient connection port under normal and single fault conditions
(see 51.101).
cc) If there is no respiratory pressure measuring device, the manufacturer shall declare the stability of
pressure control between recommended maintenance times.
NOTE This requirement applies whether or not the respiratory pressures are adjustable by the patient.
dd) The maximum A-weighted sound pressure level and sound power level measured as described in
Clause 26.
ee) The extreme conditions of operation (see 10.102).
ff) The humidification system output if the sleep apnoea breathing therapy equipment contains an integral
humidifier.
gg) For equipment not intended for use in conjunction with oxidants (see Clause 43), a warning to the effect
that sources of oxygen should be located more than 1 m from the equipment.
hh) If provided, the exchange interval of the air inlet filter.
ii) Information about the nature and frequency of regular and preventative maintenance of the equipment,
including information about the replacement of consumable components of the equipment during its intended
life.
6 © ISO 2007 – All rights reserved

ISO 17510-1:2007(E)
6.8.3 Technical description
Addition:
aa) Additional general information:
The technical description shall include the following:
⎯ all information necessary to check that the equipment is installed correctly and is in safe and correct
working order;
⎯ the maximum steady limiting pressure (P ) when tested as described in 51.101;
lim, max
⎯ if appropriate, the means of triggering;
⎯ the purpose, type, range and sensing position of all measuring and display devices, either incorporated
into the equipment or recommended by the manufacturer for use with the equipment including the
description(s) of the interface(s) necessary for equipment set-up and safe operation;
1)
⎯ unless measured or displayed parameters are expressed under ATPD conditions, the conditions under
2)
which they are expressed (e.g. BTPS );
⎯ description of operator-detachable breathing gas pathway components including breathing system filters;
⎯ functional diagram of the pneumatic flow path through the equipment;
⎯ details of any restrictions on the sequence of components within the breathing gas pathway, e.g. where
such components are flow-direction sensitive;
⎯ interdependence of controls;
⎯ accuracies and ranges of displayed values and calibrated controls;
NOTE The accuracy could be expressed in the form of maximum zero error (bias) quoted in appropriate units plus a
sensitivity error, e.g. quoted as percentage of the reading.
⎯ if applicable, battery life and description of battery replacement and charging;
⎯ equipment function after interruption and restoration of the power supply;
bb) if appropriate, a statement to the effect that combinations with other medical devices can alter the
performance of the equipment, e.g. combinations with humidifier, filters, heat and moisture exchangers,
breathing system filters or exhaust ports other than recommended.
cc) A statement on proper disposal at the end of the equipment's life.

1) ATPD: Ambient Temperature and Pressure, Dry.
2) BTPS: Body Temperature and Pressure, Saturated.
ISO 17510-1:2007(E)
7 Power input
IEC 60601-1:1988, Clause 7 applies.
8 Basic safety categories
IEC 60601-1:1988, Clause 8 applies.
9 Removable protective means
IEC 60601-1:1988, Clause 9 applies.
10 Environmental conditions
IEC 60601-1:1988, Clause 10 applies, except as follows.
10.1 Transport and storage
Amendment (add at end of paragraph):
Packaging of sterile equipment or equipment parts shall ensure sterile conditions until opened or damaged or
until its expiration date is reached.
Consideration should be given to the disposal of packaging waste.
Addition:
10.101 Electrical and pneumatic driving power supplies
The equipment shall continue to function within the specified tolerances throughout the range of supply
variation specified by the manufacturer.
10.102 * Operation under extreme conditions
Outside the environmental and supply conditions specified in IEC 60601-1:1988, 10.2, but within the limits
stated below, the equipment shall not cause a safety hazard to the patient or operator.
⎯ ambient temperature range of 5 °C to 40 °C;
⎯ ambient relative humidity range of 15 % RH to 95 % RH;
⎯ AC supply voltage range of −15 % to +10 % of declared nominal value;
⎯ DC supply voltage range of −15 % to +25 % of declared nominal value.
NOTE The equip
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