EN ISO 21647:2009

SLOVENSKI STANDARD
01-julij-2009
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SIST EN ISO 21647:2005
SIST EN ISO 21647:2005/AC:2006
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Medical electrical equipment - Particular requirements for the basic safety and essential
performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
Appareils électromédicaux - Prescriptions particulières relatives à la sécurité et aux
performances de base des moniteurs de gaz respiratoires (ISO 21647:2004, Cor 1:2005
inclus)
Ta slovenski standard je istoveten z: EN ISO 21647:2009
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 21647
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 21647:2004
English Version
Medical electrical equipment - Particular requirements for the
basic safety and essential performance of respiratory gas
monitors (ISO 21647:2004, including Cor 1:2005)
Appareils électromédicaux - Prescriptions particulières
relatives à la sécurité et aux performances de base des
moniteurs de gaz respiratoires (ISO 21647:2004, Cor
1:2005 inclus)
This European Standard was approved by CEN on 21 March 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 21647:2009: 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 21647:2004, including Cor 1:2005 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 EN ISO 21647:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 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 21647:2004.
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 21647:2004, including Cor 1:2005 has been approved by CEN as a EN ISO 21647:2009
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 – Correspondence between this European Standard and EU Directives

Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
- 6a) This relevant Essential Requirement
is not addressed in this European
Standard
- 7.5 (1st paragraph, 2nd sentence and These relevant Essential
2nd and 3rd paragraphs) Requirements are not addressed in
this European Standard
- 12.1a) This relevant Essential Requirement
is not addressed in this European
Standard
6.1 d) 13.3a) This relevant Essential Requirement
is only partly addressed in this
European Standard
6.1 d) 13.2, 13.3 a)
6.1 aa) to 6.1 hh) 13.2
6.1 dd) 13.3 f) The relevant Essential Requirement
13.3 f) is partly addressed
6.1 ee) 13.3 k)
6.1 ff) 13.3 e)
6.8.2 aa) 13.4
6.8.2 cc) 1) 6.8.2 hh), 13.6 b)
6.8.2 cc) 2) 13.6 a), 13.6 b)
6.8.2 cc) 3) 13.6 a), 13.6 d), 13.6 i)
6.8.2.cc) 3 13.6.h) The relevant Essential Requirement
13.6 h) is partly addressed
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
- 13.6 q) This relevant Essential Requirement
is not addressed in this European
Standard
6.8.2 cc) 3) iv) 13.6 a), 13.6 h) The relevant Essential Requirement
13.6 h) is partly addressed
6.8.2 dd) 13.6 a), 13.6 c)
6.8.2 ee) 13.6 c)
6.8.2 ff) to 6.8.2 hh) 13.6 a)
Table BB.1 also applies.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
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 Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
- 1.1.4 This relevant Essential
Requirement is not addressed
in this EN
6.2, 101.3 1.5.4 This relevant Essential
Requirement is not fully
addressed in this EN
- 1.6.1 This relevant Essential
Requirement is not completely
addressed in this EN; see also
reference to IEC 60601-1
- 1.6.2 This relevant Essential
Requirement is not addressed
in this EN
- 1.6.3 This relevant Essential
Requirement is not completely
addressed in this EN; see
reference to IEC 60601-1
- 3.6.2 This relevant Essential
Requirement is not completely
addressed in this EN; see
reference to IEC 60601-1
INTERNATIONAL ISO
STANDARD 21647
First edition
2004-11-15
Medical electrical equipment — Particular
requirements for the basic safety and
essential performance of respiratory gas
monitors
Appareils électromédicaux — Prescriptions particulières relatives à la
sécurité et aux performances de base des moniteurs de gaz
respiratoires
Reference number
ISO 21647:2004(E)
©
ISO 2004
ISO 21647:2004(E)
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©  ISO 2004
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ii © ISO 2004 – All rights reserved

ISO 21647:2004(E)
Contents Page
Foreword. vi
Introduction . vii
1* Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 4
4.101 Other test methods . 4
4.102 Acceptance criteria . 4
5 Classification. 5
6 Identification, marking and documents. 5
6.1 Marking on the outside of equipment or equipment parts . 5
6.3 Markings of controls and instruments. 5
6.8.2* Instructions for use. 6
6.101* Test for legibility . 8
7 Power input. 8
8 Basic safety categories . 8
9 Removable protective means . 8
10 Environmental conditions. 8
10.1 Transport and storage . 8
10.2.2 Power supply. 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. 9
21* Mechanical strength . 9
21.101 Shock and vibration. 10
21.102 Shock and vibration for transport . 10
22 Moving parts. 11
23 Surfaces, corners and edges. 11
24 Stability in normal use. 11
25 Expelled parts. 11
26 Vibration and noise. 12
ISO 21647:2004(E)
27 Pneumatic and hydraulic power .12
28 Suspended masses.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
33 Infra-red radiation.12
34 Ultraviolet radiation.12
35 Acoustical energy (including ultrasonics).12
36* Electromagnetic compatibility .12
37 Locations and basic requirements.13
38 Marking and 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
42 Excessive temperatures .13
43* Fire prevention.13
43.101 RGM used in conjunction with oxidants.13
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.14
44.3 Spillage.14
44.7 Cleaning, sterilization and disinfection .14
44.8 Compatibility with substances used with the equipment .14
45 Pressure vessels and parts subject to pressure .15
46 Human errors .15
47 Electrostatic charges .15
48 Biocompatibility.15
49 Interruption of the power supply .15
49.101 Power failure alarm conditions.15
49.102 Settings and data storage following short interruptions or automatic switchover .15
49.103 Reserve electrical power source .16
49.104 Reserve electrical power source for use outside the healthcare facility .16
50 Accuracy of operating data .16
51 Protection against hazardous output.16
51.101* Measurement accuracy.16
51.102 Total system response time .19
51.103 Indication of gas readings units of measure.20
51.104 Indication of operating mode.20
52 Abnormal operation and fault conditions.20
53 Environmental tests .20
54 General .20
55 Enclosures and covers .20
56 Components and general assembly.20
56.7 Batteries .20
iv © ISO 2004 – All rights reserved

ISO 21647:2004(E)
57 Mains parts, components and layout. 20
57.3 Power supply cords . 21
58 Protective earthing — terminals and connections . 21
59 Construction and layout. 21
101 Additional requirements specifically related to respiratory gas monitors . 21
101.1 Interfering gas and vapour effects . 21
101.2 Gas leakage . 22
101.3* Exhaust port connector for diverting respiratory gas monitor. 22
101.4 Minimum sampling flowrate. 22
101.5 Contamination of breathing systems. 23
102 Alarm systems. 23
201.1.2* Alarm condition priority. 23
201.2 Disclosures for intelligent alarm system. 25
201.5 Alarm presets . 25
201.5.1 General requirements . 25
201.6.2 Adjustable alarm limit. 25
201.8 Alarm signal inactivation states . 25
201.8.3 Indication and access. 25
103 Appendices of IEC 60601-1:1988. 25
Annex A A (informative) Rationale. 26
Annex B B (informative) Reference to the Essential Principles . 33
Annex C C (informative) Environmental aspects . 36
Annex D D (informative) Vocabulary — Index of defined terms . 38
Bibliography . 40

ISO 21647:2004(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 21647 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This first edition of ISO 21647 cancels and replaces ISO 7767:1997, ISO 9918:1993 and ISO 11196:1995,
which have been technically revised.
vi © ISO 2004 – All rights reserved

ISO 21647:2004(E)
Introduction
This International Standard 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
standard for the safety of all 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 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 International Standard, the following drafting conventions have been applied.
The changes to the text of IEC 60601-1:1988, 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 Particular Standard.
 “Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list
element, note, table, figure) additional to the General Standard.
 “Amendment” means that existing text of the General Standard is partially modified by deletion and/or
addition as indicated by the text of this Particular Standard.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this International Standard: clauses, 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.
In this International Standard, the following print types are used:
 requirements, compliance with which can be tested, and definitions: roman type;
 notes and examples: smaller roman type;
 description of type of document change, and test specifications: italic type;
 terms defined in Clause 2 of the General Standard IEC 60601-1:1988 or in this Particular Standard: bold.
Throughout this Particular Standard, text for which a rationale is provided in Annex AA, is indicated by an
asterisk (*).
INTERNATIONAL STANDARD ISO 21647:2004(E)

Medical electrical equipment — Particular requirements for the
basic safety and essential performance of respiratory gas
monitors
1* Scope
IEC 60601-1:1998, Clause 1, applies, except as follows.
Amendment (add at the end of 1.1):
This International Standard specifies particular requirements for the basic safety and essential performance of
respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans.
This International Standard specifies requirements for
aa) anaesthetic gas monitoring,
bb) carbon dioxide monitoring,
cc) oxygen monitoring.
This International Standard is not applicable to monitors intended for use with flammable anaesthetic agents.
The requirements of this International Standard which replace or modify the requirements of
IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the
corresponding general requirements.
Environmental aspects are addressed in Annex CC.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.
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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied
ISO 23328 (all parts), Breathing system filters for anaesthetic and respiratory use
IEC 60068-2-27, Environmental testing. Part 2: Tests. Test Ea and guidance: Shock
ISO 21647:2004(E)
IEC 60068-2-32:1975, Environmental testing. Part 2: Tests. Test Ed: Free fall,
Amendment 1:1982,
Amendment 2:1990
IEC 60068-2-64 Environmental testing. Part 2: Test methods — Test Fh: Vibration, broad-band random
(digital control) and guidance
IEC 60079-4, Electrical apparatus for explosive gas atmospheres. Part 4: Method of test for ignition
temperature
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety,
Amendment 1:1991
Amendment 2;1995
IEC 60601-1-2:2001, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1: General requirements for safety — Collateral standard:
6, Usability: Analysis, test and validation of human factors compatibility
IEC 60601-1-8:2003, Medical electrical equipment — Part 1-8: General requirements for safety — Collateral
standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and
medical electrical systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1 and the following apply.
NOTE For convenience, the sources of all defined terms used in this International Standard are given in Annex DD.
3.1
applied part
Amendment to IEC 60601-1:1988 subclause 2.1.5 (add between first and second dashes):
 is intended to be connected with the breathing system, e.g. for a non-diverting respiratory gas monitor,
the sensor, or for a diverting respiratory gas monitor, the sample gas inlet at the RGM
3.2
clearly legible
capable of being read by the operator or other relevant person with normal vision
1)
[IEC 60601-1:— , definition 3.14]
NOTE See 6.101 for further information.
3.3
delay time
time from a step-function change in gas level at the sampling site to the achievement of 10 % of the final
gas reading of the RGM
3.4
displayed
〈output data on the RGM〉 visually represented

1) To be published (revision of IEC 60601-1:1988).
2 © ISO 2004 – All rights reserved

ISO 21647:2004(E)
3.5
diverting respiratory gas monitor
sidestream monitor
RGM that transports a portion of respiratory gases from the sampling site through a sampling tube to the
sensor, which is remote from the sampling site
3.6
drift
change in the gas reading of an RGM, for a given gas level over a stated period of time, under reference
conditions that remain constant
3.7
gas level
content of a specific gas in a gaseous mixture
3.8
gas reading
measured gas level as displayed by the RGM
3.9
measurement accuracy
quality which characterizes the ability of an RGM to give indications approximating to the true value of the
quantity measured
3.10
*minimum alveolar concentration
MAC
alveolar concentration of an inhaled anaesthetic agent that, in the absence of other anaesthetic agents and at
equilibrium, prevents 50 % of subjects from moving in response to a standard surgical stimulus
NOTE For the purposes of this International Standard, MAC is calculated from the end-tidal gas content.
3.11
non-diverting respiratory gas monitor
mainstream monitor
RGM that uses a sensor at the sampling site
3.12
oxygen-rich environment
environment in which the partial pressure of oxygen is greater than 27,5 kPa
1)
NOTE Adapted from IEC 60601-1:— , definition 3.76.
3.13
partial pressure
pressure that each gas in a gas mixture would exert if it alone occupied the volume of the mixture at the same
temperature
3.14
reserve electrical power source
part of the medical electrical equipment that temporarily supplies power to the electrical system in the event
of an interruption of the primary electrical supply
3.15
respiratory gas monitor
RGM
medical electrical equipment intended to measure the gas level(s) or partial pressure(s) in respiratory
gases
ISO 21647:2004(E)
NOTE The RGM consists of a complete monitor including accessories, sensor, and sampling tube (in the case of a
diverting respiratory gas monitor) specified by the manufacturer in the accompanying documents for the intended
use of the RGM.
3.16
sampling site
〈diverting respiratory gas monitor〉 location at which respiratory gases are diverted for measurement to a
remote sensor
3.17
sampling site
〈non-diverting respiratory gas monitor〉 location of the sensor
3.18
sampling tube
conduit for transfer of gas from the sampling site to the sensor in a diverting respiratory gas monitor
3.19
sensor
part of the RGM that is sensitive to the presence of the respiratory gas
3.20
total system response time
time from a step function change in gas level at the sampling site to the achievement of 90 % of the final
gas reading of the RGM
3.21
use-by
〈time frame〉 describing last date during which the RGM or any of its components, when stored in its original
container under conditions in accordance with the accompanying documents, is intended to be put into
service
3.22
volume fraction
volume of a gas in a mixture, expressed as a percentage of the total volume
4 General requirements and general requirements for tests
IEC 60601-1:1988, Clauses 3 and 4, apply, except as follows.
Addition:
4.101 Other test methods
The manufacturer may use type tests different from those detailed within this International Standard, if an
equivalent degree of safety is obtained. However, in the event of dispute, the methods specified in this
International Standard shall be used as the reference methods.
4.102 Acceptance criteria
Many of the test clauses within this International Standard establish acceptance criteria for performance
aspects. These acceptance criteria shall always be met.
When the manufacturer chooses to specify in the accompanying documents performance levels better than
those specified within this International Standard, these manufacturer-specified levels become the acceptance
levels and shall also be met (e.g. see Clauses 50 and 101).
4 © ISO 2004 – All rights reserved

ISO 21647:2004(E)
5 Classification
IEC 60601-1:1988, Clause 5, applies.
6 Identification, marking and documents
IEC 60601-1:1988, Clause 6, applies, except as follows.
6.1 Marking on the outside of equipment or equipment parts
Replacement:
d) If the size of the RGM does not permit the complete marking as specified throughout this clause, at least
the following shall be marked on the RGM:
 the name and address of the manufacturer or authorized representative, if applicable;
 a serial (or Symbol 3.16 from ISO 15223:2000) or lot or batch (or Symbol 3.14 from ISO 15223:2000)
identifying number; and
 Symbol ISO 7000-0434.
Addition:
aa) All operator-interchangeable components of an RGM that are flow-direction sensitive shall be marked
with a clearly legible arrow showing the direction of gas flow.
bb) Each RGM sampling gas inlet shall be marked either with the clearly legible text “Gas sample” or with
the Symbol ISO 7000-0794.
cc) Each RGM sampling gas outlet shall be marked either with the clearly legible text “Gas exhaust” or with
the Symbol ISO 7000-0795.
dd) Packages for single-use components shall be marked with the following words: “Single use” or “Single
patient use” or the Symbol ISO 7000-1051.
ee) If the RGM contains any latex based components it shall be marked with the following word: “Latex”.
ff) If appropriate, the use-by date or Symbol 3.12 from ISO 15223:2000.
gg) All sampling tubes shall be marked either with the clearly legible text “Gas sample” or with the Symbol
ISO 7000-0794.
hh) Any gas exhaust tube for a diverting respiratory gas monitor shall be marked either with the clearly
legible text “Gas exhaust” or with the Symbol ISO 7000-0795.
ii) The RGM and its parts shall be marked with regard to proper disposal, as appropriate.
6.3 Markings of controls and instruments
g)
Amendment. Add at the beginning:
Gas reading should be marked in kilopascals (kPa).
Amendment. Add after last dash:
ISO 21647:2004(E)
Units outside the International System, which alternatively may be used on an RGM:
 gas reading
 % (volume fraction, see 3.22);
 millimetres of mercury;
 gas reading of anaesthetic agents
 % (volume fraction, see 3.22)
 MAC (minimum alveolar concentration) can be displayed additionally (see Table 107).
6.8.2* Instructions for use
Addition:
aa) Description of the intended use of the RGM;
bb) A description of the principles of operation of the RGM;
It is recommended that illustrated service information be provided that includes the following: instructions
for preventive maintenance and service calibration, and those adjustments that are necessary to maintain
the RGM in the correct operating condition, as well as a description of those adjustments and
replacements that can be performed by the user.
cc) The instructions for use shall include the following where applicable:
1) performance specifications:
i) in a diverting respiratory gas monitor, the sampled gas flowrates and their tolerances;
ii) the gas reading alarm limit range and its discrimination;
iii) the detection threshold for a single halogenated anaesthetic gas in a gas mixture, and the
detection threshold(s) for multiple halogenated anaesthetic gases in a gas mixture;
iv) the ranges of temperature, atmospheric pressure and humidity for operation and for storage;
v) the time from turning on the RGM to obtaining specified operating performance;
vi) the maximum specified interval (expressed in hours) between any necessary operator
interventions to the water-handling system, based on a sample gas temperature of 37 °C, a
room temperature of 23 °C and sample relative humidity of 100 %. This interval shall be stated
for both the specified minimum and maximum sample flowrates;
vii) a statement indicating whether or not the RGM is equipped with automatic barometric pressure
compensation;
viii) if MAC gas readings are provided, the MAC values or algorithms used to determine the MAC
values displayed by the RGM;
ix) total system response time (see 51.102);
x) drift of measurement accuracy (see 51.101.2).
6 © ISO 2004 – All rights reserved

ISO 21647:2004(E)
2) known adverse effects on stated performance due to the following:
i) quantitative effe
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