SIST EN 60601-3-1:1998

SLOVENSKI STANDARD
01-september-1998
Medical electrical equipment - Part 3-1: Essential performance requirements for
transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
(IEC 60601-3-1:1996)
Medical electrical equipment -- Part 3-1: Essential performance requirements for
transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment
Medizinische elektrische Geräte -- Teil 3-1: Wesentliche Anforderungen an die
Leistungsfähigkeit für Geräte für die transkutane Partialdrucküberwachung von
Sauerstoff und Kolhlendioxid
Appareils électromédicaux -- Partie 3-1: Prescriptions essentielles de performances pour
les appareils de surveillance de la pression partielle transcutanée de l'oxygène et du
dioxyde de carbone
Ta slovenski standard je istoveten z: EN 60601-3-1:1996
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

NORME
CEI
INTERNATIONALE
IEC
601-3-1
INTERNATIONAL
Première édition
STANDARD
First edition
1996-07
Appareils électromédicaux –
Partie 3-1:
Prescriptions essentielles de performances pour les
appareils de surveillance de la pression partielle
transcutanée de l'oxygène et du dioxyde de carbone
Medical electrical equipment –
Part 3-1:
Essential performance requirements for
transcutaneous oxygen and carbon dioxide
partial pressure monitoring equipment
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601-3-1 © IEC:1996 – 3 –
CONTENTS
Page
FOREWORD 5
INTRODUCTION 7
Clause
1 Scope and object 9
2 Normative references 9
3 Definitions 11
4 Test conditions 11
5 ACCOMPANYING DOCUMENTS 15
6 Accuracy 15
7 RESPONSE TIME 19
8 Recorder 21
9 WARNING SIGNALS 21
10 INTERNAL ELECTRICAL POWER SOURCE 21
11 TRANSDUCERS and cables 21
Figures
1 Suggested test fixture for TRANSDUCER test, if the manufacturer does not
recommend another test chamber 23
2 Test cycle for linearity test – Example of typical results 25
Annex A – Guidance and rationale 27

601-3-1 © IEC:1996 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
MEDICAL ELECTRICAL EQUIPMENT –
Part 3-1: Essential performance requirements
for transcutaneous oxygen and carbon dioxide
partial pressure monitoring equipment
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization
comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to
promote international co-operation on all questions concerning standardization in the electrical and electronic
fields. To this end and in addition to other activities, the IEC publishes International Standards. Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt
with may participate in this preparatory work. International, governmental and non-governmental
organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the
International Organization for Standardization (ISO) in accordance with conditions determined by agreement
between the two organizations.
The formal decisions or agreements of the IEC on technical matters, express as nearly as possible, an
2)
international consensus of opinion on the relevant subjects since each technical committee has
representation from all interested National Committees.
The documents produced have the form of recommendations for international use and are published in the
3)
form of standards, technical reports or guides and they are accepted by the National Committees in that
sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
6)
of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 601-3-1 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
The text of this Particular Standard is based on the following documents:
Report on voting
FDIS
62D/209/RVD
62D/189/FDIS
Full information on the voting for the approval of this Particular Standard can be found in the
report on voting indicated in the above table.
Annex A is for information only.
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
— notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
test specifications: in italic type;
–
— TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN
CLAUSE 3 AND IN IEC 601-1: SMALL CAPITALS

- 7 -
601-3-1 © IEC:1996
INTRODUCTION
These performance requirements, while different in presentation from ASTM standard
specification for transcutaneous gas monitoring devices for oxygen and carbon dioxide
F984-86, are closely aligned with those requirements.
Essential performance requirements for transcutaneous oxygen and carbon dioxide partial
pressure monitoring equipment constitute a Part 3 of IEC 601, as long as these
requirements for the functional performance do not directly affect safety.
A particular standard for functional performance does not normally specify minimum levels
of performance but requires the disclosure of the functional performance of the equipment in
a standardized way in order that users, manufacturers and test authorities have a common
understanding of the parameters concerned.
A Part 3 contains the terminology, terms and definitions applicable to a particular kind of
medical electrical equipment as well as the tests to be used in order that a manufacturer's
declared performance can be tested in a uniform and acceptable way.
The numbering of clauses and subclauses of this Particular Standard do not relate to those
of the General Standard IEC 601-1.
A 'Guidance and rationale' section for the more important requirements is given in annex A.
Clauses or subclauses for which there are explanatory notes in annex A are marked with an
asterisk (*).
It is considered that a knowledge of the reasons for these requirements will not only
facilitate the proper application of the standard but will, in due course, expedite any revision
necessitated by changes in clinical practices or as a result of developments in clinical
technology. However, this annex does not form part of the requirements of this Particular
Standard.
601-3-1 © IEC:1996 – 9 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 3-1: Essential performance requirements
for transcutaneous oxygen and carbon dioxide
partial pressure monitoring equipment
1 Scope and object
1.1* Scope
This part of IEC 601 is a Particular Standard which specifies essential requirements for the
performance of TRANSCUTANEOUS OXYGEN AND CARBON DIOXIDE PARTIAL PRESSURE MONITORING
EQUIPMENT as defined in 3.1, hereinafter referred to as EQUIPMENT.
It applies to transcutaneous monitors intended for use with adults, children and neonates,
and includes the use of these devices in foetal monitoring during birth.
It does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of
the body other than the skin such as conjunctiva or mucosa.
1.2 Object
The object of this standard is to establish certain requirements for a satisfactory level of
performance for EQUIPMENT and to establish test conditions for certain disclosure
requirements.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this part of IEC 601. At the time of publication, the editions indicated
were valid. All normative documents are subject to revision, and parties to agreements
based on this part of IEC 601 are encouraged to investigate the possibility of applying the
most recent editions of the normative documents indicated below. Members of IEC and ISO
maintain registers of currently valid International Standards.
IEC 601-1: 1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
Amendment 2 (1995)
IEC 601-2-23: 1993, Medical electrical equipment – Part 2: Particular requirements for the
safety of transcutaneous partial pressure monitoring equipment

601-3-1 © IEC:1996 – 11 –
3 Definitions
For the purposes of this part of IEC 601, the definitions given in IEC 601-2-23, together with the
following definitions, apply.
3.1 TRANSCUTANEOUS OXYGEN AND CARBON DIOXIDE PARTIAL PRESSURE MONITORING EQUIPMENT
(EQUIPMENT)
Device and associated
TRANSDUCERS for the monitoring and/or recording of partial pressures of
oxygen and carbon dioxide at the skin surface.
3.2 CALIBRATION INTERVAL
Recommended time between calibrations as described in the ACCOMPANYING DOCUMENTS.
3.3 GAS CONCENTRATION
Volume fraction of the gas expressed as a percentage referred to dry conditions and constant
barometric pressure.
3.4
TRANSDUCER
Device for converting the partial pressure of a gas into a signal for monitoring or recording.
3.5 RESPONSE TIME
Time required to display a 10 % to 90 % response to a change of partial pressure as measured
in clause 7.
NOTE — Different gases may have different response times.
4 Test conditions
4.1 Type tests
(See figure 1 for suggested test fixture.)
Tests described in this standard are type tests.
Prior to carrying out the type tests, the EQUIPMENT shall be stored, prepared for use, stabilized
and calibrated with test gas(es) according to the manufacturer's instructions for use.
4.2* Operating conditions
The EQUIPMENT shall satisfy the requirements of this standard when operating under the
following conditions:
4.2.1 Mains voltage fluctuations ±10 % of RATED voltage
4.2.2 A mains frequency which deviates not more than 1 Hz from the NOMINAL value up to
100 Hz and not more than 1 % from the NOMINAL value from 100 Hz to 1 kHz.

– 13 –
601-3-1 © IEC:1996
4.2.3 Battery voltage variations: see clause 10.
4.2.4 Ambient temperature range for the monitor: 10 °C to 40 °C. Ambient temperature
less 3 °C.
range for the TRANSDUCER: 15 °C to SET TEMPERATURE
4.2.5 a) Relative humidity range 30 % to 75 % (without condensation) for the monitor.
b) Relative humidity range 30 % to 95 % (without condensation) for the TRANSDUCER.
4.2.6 Atmospheric pressure range 70,0 kPa to 106,0 kPa (525 mm Hg to 795 mm Hg).
4.3 Environmental conditions
a) After the EQUIPMENT to be tested has been set up according to the instructions for use,
the tests are carried out under normal operating conditions at:
– an ambient temperature within the range 15 °C to 35 °C;
– a relative humidity within the range 45 %/o 75 %;
an atmospheric pressure within the range 86,0 kPa to 106,0 kPa (645 mm Hg to
–
795 mm Hg).
NOTES
1 For reference tests (if the results are dependent on the ambient conditions), three sets of specified
atmospheric conditions are recognized and it is recommended that only one of these be used for any particular
application (see table 1). The one that is chosen is at the discretion of the test house.
2 It is acceptable to use the ambient conditions prevailing in the test house at the time of the test provided that
these conditions are within the limits specified above, are monitored and recorded and any necessary corrections
made for them.
b) The EQUIPMENT shall be shielded from other conditions which might affect the validity
of the tests (for example draughts).
If ambient temperatures cannot be maintained, the test conditions shall be modified in
c)
consequence and the results adjusted accordingly.
Table 1 – Specified atmospheric conditions
a b c
Temperature°C 20 ± 2 23 ± 2 27 ± 2
Relative humidity % 65 ± 5 50 ± 5 65 ± 5
Atmospheric pressure 86,0 kPa to 106,0 kPa
(645 mm Hg to 795 mm Hg)
4.4 Alternative TRANSDUCERS Or ACCESSORIES
EQUIPMENT for which alternative TRANSDUCERS or ACCESSORIES are specified shall be tested
with each specified TRANSDUCER or ACCESSORY.
4.5 Test SET TEMPERATURE
shall be any one of the manufacturer's recommended
The test SET TEMPERATURE
temperature set points.
601-3-1 © IEC:1996 – 15 –
4.6
Test gases
The test gas concentrations specified in table 2 shall be used:
Table 2 – Test gas concentrations (VN)
CO2 N2
Test gas 1 2 %
3 % 95 %
Test gas 2
10 % 5% 85 %
Test gas 3 20,9 % 10 % 69,1 %
AC
The relative accuracy of the gas concentration — x 100 % shall be better than 0,5 %, where
c
c
is the gas concentration and Ac is the concentration error.
In the case of testing a single oxygen TRANSDUCER or the oxygen part of a combined sensor,
tes
...