SIST EN 60601-2-23:2015

SLOVENSKI STANDARD
SIST EN 60601-2-23:2015
01-december-2015
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SIST EN 60601-2-23:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DVNR]LNRåQRQDG]RURYDQMHGHOQHJDSDUFLDOQHJD
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Medical electrical equipment - Part 2-23: Particular requirements for basic safety and
essential performance of transcutaneous partial pressure monitoring equipment
Appareils électromédicaux - Partie 2-23: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de surveillance de la pression partielle
transcutanée
Ta slovenski standard je istoveten z: EN 60601-2-23:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-23:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-23:2015

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SIST EN 60601-2-23:2015


EUROPEAN STANDARD EN 60601-2-23

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2015
ICS 11.040.55 Supersedes EN 60601-2-23:2000
English Version
Medical electrical equipment - Part 2-23: Particular requirements
for the basic safety and essential performance of transcutaneous
partial pressure monitoring equipment
(IEC 60601-2-23:2011)
Appareils électromédicaux - Partie 2-23: Exigences Medizinische elektrische Geräte - Teil 2-23: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance de la pression wesentlichen Leistungsmerkmale von Geräten für die
partielle transcutanée transkutane Partialdrucküberwachung
(IEC 60601-2-23:2011) (IEC 60601-2-23:2011)
This European Standard was approved by CENELEC on 2015-09-15. CENELEC 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-CENELEC
Management Centre or to any CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-2-23:2015 E

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SIST EN 60601-2-23:2015
EN 60601-2-23:2015
European foreword
The text of document 62D/885/FDIS, future edition 3 of IEC 60601-2-23, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-23:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-23:2000.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-23:2011 was approved by CENELEC as a
European Standard without any modification.
2

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SIST EN 60601-2-23:2015
EN 60601-2-23:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral Standard: General
requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical
systems
Addition to Annex ZA of EN 60601-1:2006:
EN 60601-2-49 2015
IEC 60601-2-49 2011 Medical electrical equipment -
Part 2-49: Particular requirements for the
basic safety and essential performance
of multifunction patient monitoring
equipment

3

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SIST EN 60601-2-23:2015
EN 60601-2-23:2015
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.

4

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SIST EN 60601-2-23:2015
IEC 60601-2-23
®

Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-23: Particular requirements for the basic safety and essential performance
of transcutaneous partial pressure monitoring equipment

Appareils électromédicaux –
Partie 2-23: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression partielle transcutanée


INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.55 ISBN 978-2-88912-370-4


® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-23:2015
– 2 – 60601-2-23 © IEC:2011
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 10
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
202 Electromagnetic compatibility – Requirements and tests . 24
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 28
Annexes . 34
Annex AA (informative) Particular guidance and rationale . 35
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 43
Index of defined terms used in this particular standard. 46

Figure 201.101 – TRANSDUCER cable strain relief test . 14
Figure 201.102 – Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105) . 15
Figure 201.103 – Linearity and hysteresis test set-up – Gas mix chamber, assembled . 20
Figure 201.104 – Linearity and hysteresis test set-up – Gas mix chamber,
manufacturing dimensions . 21
Figure 201.105 – Linearity and hysteresis test set-up – Gas mix chamber, dimensions
of hose connector . 22
Figure 202.101 – Set-up for radiated and conducted EMISSIONS testing according to
202.6.1.1.2 a) . 25
Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2 . 27
Figure BB.1 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 43
Figure BB.2 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 43
Figure BB.3 – LATCHING ALARM SIGNALS with ALARM RESET . 44
Figure BB.4 – Two ALARM CONDITIONS with ALARM RESET . 44

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SIST EN 60601-2-23:2015
60601-2-23 © IEC:2011 – 3 –
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 201.102 – Required readings and tolerances . 19
Table 201.103 – Calibration test gases . 19
Table 208.101 – ALARM CONDITION priorities . 29
Table 208.102 – Characteristics of the burst of auditory ALARM SIGNALS . 30

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SIST EN 60601-2-23:2015
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial
pressure monitoring equipment


FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-23 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 1999 and constitutes a
technical revision. This edition of IEC 60601-2-23 was revised to align structurally with the
2005 edition of IEC 60601-1.

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SIST EN 60601-2-23:2015
60601-2-23 © IEC:2011 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/885/FDIS 62D/907/RVD

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.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

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SIST EN 60601-2-23:2015
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The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN 60601-2-23:2015
60601-2-23 © IEC:2011 – 7 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT. It amends and supplements
IEC 60601-1 (third edition, 2005): Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance, hereinafter referred to as the
general standard.
The aim of this third edition is to bring this particular standard up to date with reference to the
third edition of the general standard through reformatting and technical changes.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard is included in Annex AA. It is considered that 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 practice or as a result of
developments in technology. However, Annex AA does not form part of the requirements of
this Standard.

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SIST EN 60601-2-23:2015
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MEDICAL ELECTRICAL EQUIPMENT –

Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial
pressure monitoring equipment



201.1 Scope, object and related standards
1
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and
ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a
hereinafter referred to as
system.
This standard applies to transcutaneous monitors used with adults, children and neonates,
and it includes the use of these devices in foetal monitoring during birth.
This standard does not apply to haemoglobin saturation oximeters or to devices applied to
surfaces of the body other than the skin (for example conjunctiva, mucosa).
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this standard are not covered by specific requirements in this standard except in
7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the General Standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements for TRANSCUTANEOUS PARTIAL PRESSURE MONITORING
EQUIPMENT as defined in 201.3.63.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 201.2 of this particular standard.
—————————
1
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance

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SIST EN 60601-2-23:2015
60601-2-23 © IEC:2011 – 9 –
IEC 60601-1-2:2007 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208
respectively. IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral
standards in the IEC 60601-1 series apply as published
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular ME
EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

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SIST EN 60601-2-23:2015
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201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement:
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 60601-1-8:2006, 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
Addition:
IEC 60601-2-49:2011, Medical electrical equipment - Part 2-49: Particular requirements for

the basic safety and essential performance of multifunction patient monitoring equipment
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:
201.3.8
APPLIED PART
Addition:
TRANSDUCER and its connecting lead
Replacement:
201.3.63
TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT
ME EQUIPMENT
device and associated TRANSDUCERS for the monitoring of partial pressures of oxygen and/or
carbon dioxide at the skin surface
Additional definitions:
201.3.201
APPLIED PART INTERFACE
that portion of the APPLIED PART intended to come into contact with the PATIENT'S skin
201.3.202
PATIENT CABLE
insulated wire(s) between the TRANSDUCER and the ME EQUIPMENT
201.3.203
SET TEMPERATURE
desired APPLIED PART INTERFACE temperature
201.3.204
TEMPERATURE LIMITER
means of limiting the temperature of the APPLIED PART INTERFACE

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SIST EN 60601-2-23:2015
60601-2-23 © IEC:2011 – 11 –
201.3.205
TRANSDUCER
device for converting the partial pressure of a gas into a signal for monitoring or recording
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
SINGLE FAULT CONDITION includes any single failure in the ME EQUIPMENT resulting in a transfer
of energy to the APPLIED PART which is greater than that necessary to maintain the SET
TEMPERATURE value.
Additional subclause:
201.4.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Non-linearity and hysteresis 201.12.1.101.1
Time to alarm for pO and pCO ALARM CONDITIONS 208.6.6.1.103
2 2
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Addition:
Unless otherwise stated, tests
...