ISO 17510-1:2002

INTERNATIONAL ISO
STANDARD 17510-1
First edition
2002-02-01

Sleep apnoea breathing therapy —
Part 1:
Sleep apnoea breathing therapy devices
Thérapie respiratoire de l'apnée du sommeil —
Partie 1: Dispositifs de thérapie respiratoire de l'apnée du sommeil




Reference number
ISO 17510-1:2002(E)
©
ISO 2002

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ISO 17510-1:2002(E)
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ii © ISO 2002 – All rights reserved

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ISO 17510-1:2002(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 3.
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 part of ISO 17510 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 17510 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical
Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
Throughout the text of this document, read ".this European Standard." to mean ".this International Standard.".
ISO 17510 consists of the following parts, under the general title Sleep apnoea breathing therapy:
— Part 1: Sleep apnoea breathing therapy devices
— Part 2: Masks and application accessories
Annexes AA and BB of this part of ISO 17510 are for information only.
For the purposes of this part of ISO 17510, the CEN annex regarding fulfilment of European Council Directives has
been removed.
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ISO 17510-1:2002(E)
Contents

page
Foreword vi
Introduction vii
Section one General 1
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 General requirements and general requirements for test 4
5 Classification 4
6 Identification, marking and documents 4
7 Power input 7
Section two - Environmental conditions 8
8 Basic safety categories 8
9 Removable protective means 8
10 Environmental conditions 8
11 Not used 8
12 Not used 8
Section three - Protection against electric shock hazards 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 9
Section four - Protection against mechanical hazards 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
Section five - Protection against hazards from unwanted or excessive radiation 12
29 X-radiation 12
30 Alpha, beta, gamma, neutron radiation and other particle radiation 12
31 Microwave radiation 12
32 Light radiation (including lasers) 12
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ISO 17510-1:2002(E)
33 Infra-red radiation 12

34 Ultra-violet radiation 12
35 Acoustical energy (including ultra-sonics) 12
36 Electromagnetic compatibility 12
Section six - Protection against hazards of ignition of flammable anaesthetic mixtures 13
37 Locations and basic requirements 13
38 Marking, accompanying documents 13
39 Common requirements for Category AP and Category APG equipment 13
40 Requirements and tests for Category AP equipment, parts and components thereof 13
41 Requirements and tests for Category APG equipment, parts and components thereof 13
Section seven - Protection against excessive temperatures and other safety hazards 14
42 Excessive temperatures 14
43 Fire prevention 14
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection 14
45 Pressure vessels and parts subject to pressure 14
46 Not used 15
47 Electrostatic charges 15
48 Biocompatibility 15
49 Interruption of the power supply 15
Section eight - Accuracy of operating data and protection against hazardous output 16
50 Accuracy of operating data 16
51 Protection against hazardous output 16
Section nine - Abnormal operation and fault conditions ; environmental tests 17
52 Abnormal operation and fault conditions 17
53 Environmental tests 17
Section ten - Constructional requirements 18
54 General 18
55 Enclosures and covers 18
56 Components and general assembly 18
57 Mains parts, components and layout 20
58 Protective earthing - Terminals and connections 20
59 Construction and layout 20
Annexes 20
Annex AA (informative) Rationale 21
Annex BB (informative) Glossary 25
Bibliography 26
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ISO 17510-1:2002(E)
Foreword

The text of EN ISO 17510-1:2002 has been prepared by Technical Committee CEN/TC 215 "Respiratory and
anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC
121 "Anaesthetic and respiratory equipment".
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 August 2002, and conflicting national standards shall be withdrawn at the latest by
August 2002.
This European Standard has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
Annexes AA and BB are for information only.
EN ISO 17510 consists of the following parts under the general title Sleep apnoea breathing therapy.
— Part 1: Sleep apnoea breathing therapy devices
— Part 2: Masks and application accessories.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,
Sweden, Switzerland and the United Kingdom.
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ISO 17510-1:2002(E)
Introduction

This particular standard amends and supplements EN 60601-1 (see the exact references with amendments in
clause 2).
The requirements are followed by specifications for the relevant tests.
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of EN 60601-1.
The changes to the text of EN 60601-1 are specified by the use of the following words.
"Replacement" means that the clause or subclause of EN 60601-1:1990 + A1:1993 and A12:1993 is replaced
completely by the text of this particular standard.
"Addition" means that the clause or subclause of this particular standard is additional to the requirements of
EN 60601-1.
"Amendment" means that the clause or subclause of EN 60601-1:1990 + A1:1993 and A12:1993 is amended as
indicated by the text of this particular standard.
Subclauses or figures which are additional to those of EN 60601-1:1990 + A1:1993 and A12:1993 are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Annex AA contains rationales for this European Standard. The clauses and subclauses which have corresponding
rationale statements are marked with R) after their number.
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ISO 17510-1:2002(E)
Section one General
1 Scope
The scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.
This European Standard specifies requirements for devices intended for sleep apnoea breathing therapy for
domiciliary use and for use in healthcare institutions.
Jet and very high frequency ventilation and oscillation are not considered in this part of the European Standard.
This European standard does not apply to devices covered by the scope of the EN 794 series.
Masks and application accessories are adressed in Part 2 of this Standard (in preparation).
This European Standard does not cover external body ventilators as defined in EN ISO 4135.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in text and the publications are listed hereafter. For dated
references, subsequent amendments to or revisions of any of these publications apply to this European Standard
only when incorporated in it by amendment or revision. For undated references the latest edition of the publication
referred to applies (including amendments).
EN 550, Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization.
EN 552, Sterilization of medical devices - Validation and routine control of sterilization by irradiation.
EN 554, Sterilization of medical devices - Validation and routine control of sterilization by moist heat.
Sterilization of medical devices - Requirements for medical devices to be labelled “STERILE”.
EN 556,
prEN 737-6:1998, Medical gas pipeline systems - Part 6: Dimensions of probes for terminal units for compressed
medical gases and vacuum
.
EN 739, Low-pressure flexible hose assemblies for use with medical gases.
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1 : Cones and sockets.
Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing
EN 1281-2,
connectors. (ISO 5356-2:1987 modified)
Anaesthesiology – Vocabulary (ISO 4135:1995)
EN ISO 4135:1996, .
EN ISO 8185, Humidifiers for medical use - General requirements for humidification systems.
EN 60601-1:1990 + A1:1993, A2:1995, A12:1993 and A13:1996, Medical electrical equipment - Part 1: General
requirements for safety (includes amendments A1:1993, A2:1995, A12:1993 and A13:1996) (IEC 60601-1:1988 +
A1:1991 + A2:1995 + corrigendum 1995 mod).
EN 60601-1-2, Medical electrical equipment – Part 1: General requirements for safety – 2: Collateral Standard:
electromagnetic compatibility – Requirements and tests (IEC 60601-1-2:1993)
ISO 32, Gas cylinders for medical use- Marking for identification of content.
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ISO 17510-1:2002(E)
ISO 3744, Acoustics - Determination of sound power levels of noise sources - Engineering methods for free-field
1)
conditions over a reflecting plane .
Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying
EN ISO 9360-1,
respired gases in humans – Part 1 : HMEs for use with minimum tidal volumes of 250 ml ( ISO 9360-1 :2000).
IEC 60079-4, Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition temperature.
IEC 60651:1979, Sound level meters.
3 Terms and definitions
For the purposes of this Standard, EN 60601-1:1990, clause 2 + A1:1993 and A12:1993 applies with the terms and
definitions of EN IS0 4135:1996 and the following:
2.1.5 R) applied part:
 Add the following item

all parts of the device intended to be connected to the patient or to the breathing system.
3.1
bi-level positive airway pressure device
device intended to generate two positive pressure levels at the patient connection port during the respiratory cycle
3.2
breathing system
2)
sleep apnoea therapy device breathing system bounded by the low pressure gas input port(s), the gas intake
port(s) and the patient connection port together with the fresh-gas inlet and exhaust port(s), if these are provided
NOTE Valves can be placed anywhere in relation to ports and, indeed, anywhere in the breathing system, provided the
requirements of this standard are met.
3.3
continuous positive airway pressure device ; CPAP device
device intended to generate continuous positive airway pressure at the patient connection port throughout the
respiratory cycle
3.4
fresh-gas
gas supplied to the breathing system
It excludes the following :
a) air drawn through the emergency air intake port ;
b) air drawn through leaks in the breathing system ;
c) expired gas from the patient.
3.5
fresh-gas intake port
gas intake port, other than the emergency air intake port, through which fresh-gas can be drawn into the equipment
breathing system by the equipment or the patient (see note to 3.2)

1) This reference will be replaced when EN 21201 is published by reference to EN 21201 "Acoustics – Noise emitted by
machinery and equipment – Measurement of emission sound pressure levels at the work station and at other specific positions
– Engineering method in an essentially free field over a reflecting plane".
2) See the glossary for these terms (in Annex BB)
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ISO 17510-1:2002(E)
3.6
gas exhaust port
port of the equipment from which gas is discharged to the atmosphere under normal operating conditions either
directly or via an anaesthetic gas scavenging system.
3.7
gas output port
port of the equipment through which gas is delivered at respiratory pressures through an operator-detachable part
of the breathing system to the patient connection port
3.8
gas return port
port of the equipment through which gas is returned at respiratory pressures through an operator-detachable part
of the breathing system from the patient connection port
3.9
high pressure gas input port
gas input port to which gas is supplied at a pressure greater than 100 kPa
3.10
label
printed or graphic information applied to a medical device or any of its containers or wrappers
3.11
low pressure gas input port
gas input port to which gas is supplied at a pressure not exceeding 100 kPa
3.12
marking
inscription in writing or as a symbol applied on a medical device from which the inscription is not dissociable
3.13
maximum limited pressure (P )
lim max
highest pressure measured at the patient connection port under normal and single fault conditions
3.14
microbial filter
device intended to remove bacteria other microorganisms and particles from the gas stream
3.15
patient connection port
port of the breathing system to which the patient can be connected
3.16
self-adjusting sleep apnoea breathing therapy devices
device which automatically adjusts the pressure in the breathing system according to the patient's needs during
use.
Note This device may adjust to one or more pressure levels.
3.17
sleep apnoea breathing therapy device
3)
breathing therapy device intended to alleviate the symptoms of patients who suffer from sleep apnoea , suitable
for healthcare institution and domiciliary use, primarily without professional supervision
3.18
stability of the respiratory pressure
change of the respiratory pressure set value with regard to time and change in the environmental conditions (e.g.
temperature and ageing)

3) See the glossary for these terms (in Annex BB)
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ISO 17510-1:2002(E)
3.19
variation of the respiratory pressure
difference between actual reading of the respiratory pressure and set value during the respiratory cycle
4 General requirements and general requirements for test
4.1 Clause 3 of EN 60601-1:1990 + A1:1993 and A12:1993
Clause 3 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
4.2 Clause 4 of EN 60601-1:1990 + A1:1993 and A12:1993
Clause 4 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
5 Classification
Clause 5 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
NOTE A device can have applied parts of different types.
6 Identification, marking and documents
Clause 6 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following additions and modifications :
In 6.1 (marking on the outside of equipment or equipment parts) add the following to item e) (identification of the
origin).
If imported from outside the EU, the name and address of the person responsible or of the authorized
representative of the manufacturer or the importer established within the EU shall be provided with the label or the
accompanying documents.
In 6.1 j) (power input) replace the first paragraph by the following :
The rated input shall be given in amperes.
In addition, add the following items to 6.1.
aa) All user-interchangeable flow-direction sensitive components shall be permanently marked with a clearly
legible arrow indicating the direction of flow.
bb) Any high pressure gas input port shall be marked on or in the vicinity with the name or symbol of the gas as
given in EN 739 with the range of supply pressures in kPa and with the maximum flow requirement in l/min.
cc) If operator accessible ports are provided, they shall be marked.
The following terms may be used :

fresh-gas intake port: “FRESH-GAS INTAKE” ;

gas output port: “GAS OUTPUT” ;

gas return port: “GAS RETURN” ;

gas exhaust port: “EXHAUST”.
If an optional port is dedicated for a probe, it shall be marked accordingly.
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ISO 17510-1:2002(E)
Alternatively, other terms, pictograms or symbols may be used, in which case they shall be explained and referred
to in the above terms.
dd)R) Label of the device and accessories (e.g. breathing system attachments)
The label shall contain the following :

if the intended purpose of the device is not obvious to the operator, the attachment or its package shall be
provided with an instruction leaflet or operating instructions ;

the name or tradename and address of the manufacturer and additionally for accessories imported from
outside the EU the name and address of the person responsible or of the authorised representative of the
manufacturer or the importer established within the EU ;

device identification and content information ;

where appropriate, the symbol STERILE in accordance with EN 980 and the method of sterilization ;

where appropriate, the batch code preceded by the symbol LOT in accordance with EN 980 or serial number ;

where appropriate, an indication of the date by which the device can be used, expressed as the year and
month ;

where appropriate, an indication that the device is for single use only ;
NOTE Symbol ISO 7000-1051 can be used (see EN 980).

any special storage and/or handling conditions ;

any warning and/or precaution to take ;

devices which are considered as active medical devices, year of manufacture, except those covered by 6.1dd)
th
6 dash ;
NOTE This indication can be included in the batch code or serial number.

where applicable, recommended methods of cleaning, disinfection and sterilization.
Device packaging and/or labelling shall differentiate between the same or similar products placed on the market
both sterile and non-sterile.
Packages containing breathing attachments made of conductive materials shall be clearly marked with the word
“CONDUCTIVE” or “ANTISTATIC”.
ee) If gas-specific colour-coding of flow controls and flexible hoses is provided, it shall be in accordance with
ISO 32.
In 6.8.2 add the following items.
aa) The instructions for use shall additionally include the following :

The form and the dimensions of the patient connection port (see 56 ee)) ;

cleaning requirements for components, if applicable.
bb) The maximum achievable pressure at the patient connection port under normal and single fault conditions (see
51.101).
For expiratory tidal volume, or minute volume, measurement, the range and the accuracy of the actual reading, if a
measuring device is provided.
cc) A warning statement to the effect that, for protection class 1 equipment, it is essential that the protective earth
of the domiciliary electrical installation be checked for safe and effective operation.
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ISO 17510-1:2002(E)
dd) If there is no respiratory pressure measuring device, the manufacturer shall declare the stability of pressure(s)
control between recommended maintenance times.
NOTE This requirement applies whether or not the respiratory pressures are adjustable by the patient.
ee) The maximum A-weighted sound pressure level tested as described in clause 26 with the recommended
relative position of the patient and device.
ff) The extreme conditions of operation (see 10.102).
gg) Description of how carbon dioxide re-breathing is minimised during normal and single fault conditions.
In 6.8.3 (technical description) add the following :
The following additional information shall be included in the technical description as far as applicable :

all information necessary to check that the device is installed correctly and is in safe and correct working order ;

the maximum limited pressure (P ) ;
lim max

the means of triggering ;

the purpose, type, range and sensing position of all measuring and display devices, either incorporated into
the device or recommended by the manufacturer for use with the device including the description(s) of the
interface(s) necessary for device set-up and safe operation ;
4)

unless measured or displayed parameters are expressed under ATPD conditions, the conditions under
4)
which they are expressed (e.g. BTPS ) ;

description of the alarms, principle of their detection, methods of testing their proper functioning and how to
operate them ;

description of operator detachable breathing system components including microbial filters ;

functional diagram of the pneumatic system (s) ;

details of any restrictions on the sequence of components within the breathing system, 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.

battery life and description of battery replacement and charging ;

device function after interruption and restoration of the power supply ;

maximum flow at pressures of 1/3, 2/3 and the maximum of adjustable pressure under the conditions specified
by the manufacturer ;

the pressure/volume curve and the respiratory pressure variation under the test conditions as specified in
56.103.

4) ATPD: Ambient Temperature and Pressure, Dry,
BTPS: Body Temperature and Pressure, Saturated.
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ISO 17510-1:2002(E)
7 Power input
Clause 7 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
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ISO 17510-1:2002(E)
Section two - Environmental conditions
8 Basic safety categories
Clause 8 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
9 Removable protective means
Not used.
10 Environmental conditions
Clause 10 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following additions.
10.101 Electrical and pneumatic driving power supplies
The device shall continue to function within the specified tolerances throughout the range of supply variation
specified by the manufacturer.
10.102 R) Operation under extreme conditions
The manufacturer shall declare how the device will respond as the environmental and supply conditions are
extended to the following limits, changing one parameter at a time whilst other parameters are maintained within
normal limits:

ambient temperature range of 5° C to 40 °C ;

ambient relative humidity range of 10 % RH to 95 % RH ;

atmosphere pressure range of 700 mbar to 1060 mbar ;

AC supply voltage range of - 15 % to + 10 % of declared nominal value ;

DC supply voltage range of - 15 % to + 25 % of declared nominal value.
Outside the environmental and supply conditions specified in 10.2 of EN 60601-1:1990 + A1:1993 and A12:1993
but within the limits stated above, the device shall not cause a safety hazard to the patient or operator.
NOTE The equipment might continue to function but outside the specified tolerances.
11 Not used
12 Not used
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ISO 17510-1:2002(E)
Section three - Protection against electric shock hazards
13 General
Clause 13 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
14 Requirements related to classification
Clause 14 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
15 Limitation of voltage and/or energy
Clause 15 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
16 Enclosures and protective covers
Clause 16 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
17 Separation
Clause 17 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
18 Protective earthing, functional earthing and potential equalization
Clause 18 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
19 Continuous leakage currents and patient auxiliary currents
Clause 19 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.
In 19.4 add the following to item h) :
101)R) The patient leakage current shall be measured from those applied parts classified as the same type (see
14.6 of EN 60601-1:1990 + A1:1993 and A12:1993). The parts shall be connected together electrically. Parts
connected to the protective earth terminal shall be tested separately.
20 Dielectric strength
Clause 20 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
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ISO 17510-1:2002(E)
Section four - Protection against mechanical hazards
21 Mechanical strength
Clause 21 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
22 Moving parts
Clause 22 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
23 Surfaces, corners and edges
Clause 23 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
24 Stability in normal use
Clause 24 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
25 Expelled parts
Clause 25 of EN 60601-1:1990 + A1:1993 and A12:1993 applies.
26 Vibration and noise
Clause 26 of EN 60601-1:1990 + A1:1993 and A12:1993 shall be replaced by the following:
26.101 R The A-weighted sound pressure level caused by the device and to which the patient is exposed shall
be measured under the conditions given in 26.102.
NOTE By the test set-up it should be ensured that the sound presure level measurement of the device is not interfered by
the noise caused by the tubing system and the gas flow leaving the tubing resistance system at the patient connection port.
26.102 Place the device on the floor and fit with the breathing tube as provided or recommended by the
manufacturer. Connect a resistance with 4 mm internal, 40 mm length and outlet angle of 45° to the patient
connection port (see figure 101). Acoustically isolate the tubing system and the gas leaving the resistance at the
patient connection port by a suitable means out of the testing area so that the noise caused by the tubing system
and by the gas flow is not interfering with the sound pressure measurement of the device.
Set the device in order to achieve a continuous pressure of 1 kPa a
...