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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
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ISO 21647:2004(E)

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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

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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

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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

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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.

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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 (*).

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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

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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

[IEC 60601-1:—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).

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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

NOTE Adapted from IEC 60601-1:—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

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