EN ISO 18778:2009

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 18778:2005
Respiratorna oprema - Monitorji za otroke - Posebne zahteve (ISO 18778:2005)
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Beatmungsgeräte - Überwachungsgeräte für Kleinkinder - Besondere Anforderungen
(ISO 18778:2005)
Matériel respiratoire - Moniteurs pour enfants - Exigences particulières (ISO 18778:2005)
Ta slovenski standard je istoveten z: EN ISO 18778:2009
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 18778
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 18778:2005
English Version
Respiratory equipment - Infant monitors - Particular
requirements (ISO 18778:2005)
Matériel respiratoire - Moniteurs pour enfants - Exigences Beatmungsgeräte - Überwachungsgeräte für Kleinkinder -
particulières (ISO 18778:2005) Besondere Anforderungen (ISO 18778:2005)
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 18778:2009: 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 18778:2005 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
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 18778:2005.
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 18778:2005 has been approved by CEN as a EN ISO 18778:2009 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 International Standard and Directive 93/42/EEC
Medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes

4 All
5 All
6 13, 13.2
6.1 7.5 (3rd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 12.1a) This relevant Essential
Requirement is not
addressed in this
European Standard.
6.1 d) 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this
European Standard
6.8.2aa) 13.3 (f) This relevant Essential
Requirement is not fully
addressed in this
European Standard
6.8.2 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
- 13.6 (q)
This relevant Essential
Requirement is not
addressed in this
European Standard
6.3 10.2, 10.3, 12.8, 12.9
6.8 13.1, 13.3, 13.4, 13.6
6.101 12.9
7 12.6
8 12.6
9 12.6
10.1 5
10.2 5
13 12.6
14 12.6
15 12.6
16 12.6, 12.7
17 12.6
18 12.6
19 12.6
20 12.6
21 12.7
22 12.7
23 12.7
24 12.7
25 12.7
26 12.7.2, 12.7.3
27 12.8
28 12.7
29 11
36 9.2, 12.5
38 13
39 9.2, 9.3, 12.6, 12.7
40 9.2, 9.3, 12.6, 12.7
41 9.2, 9.3, 12.6, 12.7
42 12.7
43 9.3, 12.7
44.3 7.6, 12.6
44.6 7.6, 12.6
44.7 8.1
44.8 7.1, 7.3, 7.5, 9.3
45 12.7
46 9, 10, 12.9
47 12.5
- 6a) This relevant Essential
Requirement is not
addressed in this
European Standard
- 7.5 (1st paragraph)
This relevant Essential
Requirement is not fully
addressed in this
European Standard
48 7.5 (2nd paragraph) This relevant Essential
Requirement is not fully
addressed in this
European Standard
48 7.1, 7.5
49 9.2, 12.8
50 10
51 10, 12.8
52 12.1, 12.6, 12.7, 12.8
53 5
54 9
55 9
56 9
56.3 9.1
56.7 12.2
57 12.6, 12.7
58 12.6, 12.7
101.2.1 9.2, 12.8
101.2.3 12.8
101.2.4 12.8
101.2.6 12.8
101.2.7 12.2
101.2.8 9.3, 12.6, 12.8
101.3 12.3, 12.8
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 18778
First edition
2005-02-15
Respiratory equipment — Infant
monitors — Particular requirements
Matériel respiratoire — Moniteurs pour enfants — Exigences
particulières
Reference number
ISO 18778:2005(E)
©
ISO 2005
ISO 18778:2005(E)
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ii © ISO 2005 – All rights reserved

ISO 18778:2005(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 3
5 Classification. 3
6 Identification, marking and documents. 3
7 Power input. 7
8 Basic safety categories . 7
9 Removable protective means . 8
10 Environmental conditions. 8
11 Not used. 8
12 Not used. 8
13 General. 8
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
22 Moving parts. 10
23 Surfaces, corners and edges. 10
24 Stability in normal use. 10
25 Expelled parts. 10
26 Vibration and noise. 10
27 Pneumatic and hydraulic power. 10
28 Suspended masses. 10
29 X-Radiation . 11
30 Alpha, beta, gamma, neutron radiation and other particle radiation. 11
31 Microwave radiation. 11
32 Light radiation (including lasers) . 11
33 Infrared radiation. 11
ISO 18778:2005(E)
34 Ultraviolet energy .11
35 Acoustical energy (including ultrasonics).11
36 Electromagnetic Compatibility.11
37 Locations and basic requirements.11
38 Marking and accompanying documents.11
39 Common requirements for category AP and category APG equipment.12
40 Requirements and tests for category AP equipment, parts and components thereof .12
41 Requirements and tests for category APG equipment, parts and components thereof .12
42 Excessive temperatures .12
43 Fire prevention.12
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.13
45 Pressure vessels and parts subject to pressure .13
46 Human errors .13
47 Electrostatic charges .14
48 Biocompatibility.14
49 Interruption of the power supply .14
50 Accuracy of operating data .14
51 Protection against hazardous output.14
52 Abnormal operation and fault conditions.14
53 Environmental tests .15
54 General .15
55 Enclosures and covers .15
56 Components and general assembly.15
57 Mains parts, components and layout.15
58 Protective earthing – Terminals and connections .15
59 Construction and layout .15
101 Additional requirements .16
Annex AA (informative) Rationale .20
Annex BB (informative) Environmental aspects.23
Annex CC (informative) Index of defined terms.25
Bibliography.26

iv © ISO 2005 – All rights reserved

ISO 18778:2005(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 18778 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with Technical Committee ISO/TC 121,
Anaesthetic and respiratory equipment Subcommittee SC 3, Lung ventilators and related equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
ISO 18778:2005(E)
Introduction
This International Standard specifies requirement for infant monitors (called in previous working documents
“infant apnoea monitors” but with a too restrictive scope) which are used to recognize apparent life-threatening
events in an infant who is asleep.
These devices are for domiciliary use only.
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 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/for 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 Definition of Collateral Standard and Particular 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.
This International Standard uses the same main clause titles and numbering as the General Standard, for
ease of cross-referencing of the requirements. The changes to the text of 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
item, note, table, figure) additional to the General Standard.
 “Amendment” means that an existing element 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.
The term “this Standard” is used to make reference to the General Standard and this Standard taken together.
Where there is no corresponding section, clause or subclause in this Standard, the section, clause or
subclause of the General Standard, although possibly not relevant, applies without modification, where it is
intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to
that effect is given in this Standard.
Clauses and subclauses to which there is a rationale are marked with an throughout this International
Standard, text for which a rationale is provided in Annex AA is indicated by an asterisk (*). This rationale can
be found in the informative Annex AA.

vi © ISO 2005 – All rights reserved

INTERNATIONAL STANDARD ISO 18778:2005(E)

Respiratory equipment — Infant monitors — Particular
requirements
1 * Scope
IEC 60601-1:1988, Clause 1, applies except as follows:
Amendments (add at end of 1.1):
1.1
This International Standard specifies requirements for the safety and essential performance of monitors used
1)
to detect apparent life-threatening events in sleeping or resting children under three years of age. This
International Standard applies to devices used in home care applications. These monitors are generally used
without continual professional supervision.
This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the
monitor to the patient.
This International Standard does not apply to monitors intended for use in health care facilities/institutions.
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.
1.4
Addition:
NOTE Planning and design of products complying with this Standard can have environmental impact during the
product life cycle. Environmental aspects are addressed in Annex BB. 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.
EN 71-1:1998 + A1:2001, Safety of toys — Part 1: Mechanical and physical properties
EN 980:2003, Graphical symbols for use in the labelling of medical devices
EN 1041:1998, Information supplied by the manufacturer with medical devices

1) Referred to as “monitor” throughout the document.
ISO 18778:2005(E)
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
IEC 60601-1:1988 + A1:1991 + A2:1995 and corrigendum 1995 mod, Medical electrical equipment — Part 1:
General requirements for safety
IEC 60601-1-2:2001, Medical electrical equipment — Part 1-2: General requirements for safety —Collateral
standard: Electromagnetic compatibility — Requirements and tests
IEC 60529:2001, Degree of protection provided by enclosures (IP Code)
IEC 60068-2-32:1975, Environmental testing — Part 2: Tests — Test Ed: Free fall. (A 1:1982 + A 2:1990)
IEC 60068-2-64:1993, Environmental testing — Part 2: Test methods — Test Fh: Vibration broad-band
random (digital control) and guidance
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres — Part 4: Methods of test for ignition
temperature
IEC 60601-2-23:1999, Medical electrical equipment — Part 2-23: Particular requirements for the safety,
including essential performance, of transcutaneous partial pressure monitoring equipment
IEC 60601-2-27:1994, Medical electrical equipment — Part 2-27: Particular requirements for the safety of
electrocardiographic monitoring equipment
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 9919, Medical electrical equipment — Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:1988, ISO 4135 and the
following apply.
3.1
applied part
part of the monitor intended to be connected to the patient and which in normal use:
 necessarily comes into physical contact with the patient for the infant monitor to perform its function or
 can be brought into contact with the patient or
 needs to be touched by the patient.
3.2
expected service life
period during which the performance of the monitor or any of its components is expected to meet the
requirements of this Standard when used and maintained according to the accompanying documents
3.3
shelf life
minimum period of time during which the monitor or any of its components may be stored in its original
container under conditions in accordance with the accompanying documents and able to perform according
to the manufacturer's specifications
2 © ISO 2005 – All rights reserved

ISO 18778:2005(E)
4 General requirements and general requirements for tests
IEC 60601-1:1988, Clauses 3 and 4 apply, except as follows:
Additions:
3.1 * No safety hazard in normal condition and single fault condition
Add at the end of the subclause:
Function of the monitor shall be assured under single fault condition.
NOTE In order to assure function of the monitor under single fault condition, monitoring of two physiological variables
is required (e.g. heat rate, oxygen saturation, respiratory rate).
4.101 Other test methods
Test methods other than those specified in this International Standard, but of equal or greater accuracy may
be used to verify compliance with requirements.
5 Classification
IEC 60601-1:1988, Clause 5 applies, except as follows:
Replacement:
5.2 Applied part classification
The monitor and its applied parts shall be classified as type BF or type CF.
6 Identification, marking and documents
IEC 60601-1:1988, Clause 6 applies, except as follows:
Addition:
Information and marking shall comply with EN 980 and EN 1041.
6.1 Marking on the outside of equipment or equipment parts
Replacement:
d) if the size of the monitor does not permit the complete marking as specified throughout this clause, at
least the following shall be marked on the monitor:
 the name of the manufacturer;
 a serial or lot or batch identifying number;
 symbol ISO 7000-0434 (or see Table D1, Symbol 14 in of IEC 60601-1:1988).
ISO 18778:2005(E)
Additions:
aa) the manufacturer shall mark the monitor with a caution to refer the user or operator to the
accompanying documents or symbol ISO 7000-0434 for the expected adverse effects on the
performance of the monitor;
bb) packages for single use components shall be durably marked with the following words: “single use” or
“single patient use” or the symbol ISO 7000-1051;
cc) on monitors intended for hospital use only, a permanent warning label to the effect that: “The device is not
for use in home care environment”;
dd) the monitor and its parts shall be marked regarding their proper disposal, as adequate.
6.3 Markings of controls and instruments
Additions:
Marking of controls should be clearly legible at a distance of 1 m in a range of illumination from 100 lx to
1 500 lx by an individual with a visual acuity of 1 (corrected if necessary).
All controls which increase or decrease a function shall be marked with a legible indication to inform the
operator which action(s) is (are) required to increase or decrease the controlled function.
Controls should be identified with their associated markings.
6.8 Accompanying documents
Additions:
6.8.2 * Instructions for use
Additions:
6.8.2d) Cleaning, disinfection and sterilization
 any pre-use cleaning or disinfecting procedures for the monitor and any accessories including any
specific procedure(s) necessary before the monitor is transferred to another patient;
 methods for cleaning, disinfecting or sterilizing and the recommended frequencies;
 any limitations on the number of cleaning, disinfecting or sterilizing cycles.
6.8.2aa)
Additions:
NOTE The following requirements are grouped under an appropriate headline as they usually appear in the
instructions for use. This has been done for convenience of the people involved in this. This does not mean that the
required information in the instructions for use is to be presented in the order as listed below.
1) Intended use
 a statement of the intended uses (i.e. purpose) of the monitor and an explanation on how the monitor
accomplishes that purpose;
 a description of the types of apparent life-threatening events that the device is intended to monitor;
4 © ISO 2005 – All rights reserved

ISO 18778:2005(E)
 the parameters monitored by any additional modality, if applicable;
 a description of the principles of operation of the monitor;
 the type of sensors used.
2) Precautions and hazards
 precautions to minimize the risk of strangulation, accomplished by providing instructions for routing of
patient wires and tubing in the device labelling;
 precautions to minimize hazards due to exposure to toxic materials from the monitor occasioned by
abnormal conditions;
 the location of all latex-based components;
 advice of other hazards and risks associated with the monitor;
 precaution to minimize the risk due to small parts being inhaled or swallowed and due to fingers or flesh
being entrapped.
3) Monitor information
 explanation of the function and meaning of each alarm and indicator provided with the monitor;
 a statement that the monitor may not be able to detect all life-threatening events.
4) Operating information
 clear, simple diagrams and illustrations of the fully-assembled and ready-to-operate monitor;
 steps required to prepare the monitor for operation;
 diagrams, illustrations or photos showing proper connection of the patient to the monitor and other
equipment, if applicable, including alternative recommended electrode and sensor placement;
 proper connection of auxiliary devices;
 description of appropriate warm-up procedures and intervals;
 drawings or photos of all controls, alarms and indicators provided with the monitor;
 explanation of the use of the controls, alarms and indicators;
 a step-by-step procedure for checking proper functioning of all controls, indicators and alarms;
 list of error messages, if applicable, their meaning and the corrective steps that can be taken by the
operator;
 a troubleshooting guide for use when there are indications of a monitor malfunction during checkout
and/or operation;
 the positioning of sensors and electrodes, alternate electrode placement, preparation of electrodes and
patient for electrode attachment, and identification of loose sensors and electrodes;
 procedures to follow in the event of a monitor alarm condition;
 warnings concerning the precautions necessary to avoid possible or unsafe use of the monitor;
ISO 18778:2005(E)
 connection and proper use of remote alarm units, including recommended placement and the importance
of the operator being able to access the patient as quickly as possible;
 legible reproductions of all required labels and hazard warnings on the device;
 description of the circumstances when it may be appropriate to contact the prescribing physician or health
care professional;
 recommendation to the effect that the lay operator be trained in cardiopulmonary resuscitation;
 information concerning the disposal of the monitor and its components (e.g. battery).
5) Operator maintenance instructions
 methods and materials for cleaning, disinfecting or sterilizing the monitor;
 schedule of operator-initiated maintenance including any specific procedure(s) necessary before the
monitor is transferred to another patient;
 battery care and maintenance procedures, including instructions for recharging or replacement;
 description of periodic visual safety inspections that should be performed by the operator.
6) Patient information
 clinical circumstances that might require sensor adjustment or checking for proper operation;
 circumstances related to the use of the monitor which could cause a hazardous situation
(e.g. bio-incompatibility, chemical, or thermal injury);
 instructions for preventing injury reactions, e.g. periodically repositioning electrodes.
7) Operating environment information
 the ranges of temperature, atmospheric pressure and humidity for operation and for storage;
 the time from switching “ON” to obtaining specified operating performance;
 description of known or recognizable conditions of the environment which can affect the safe and
effective operation of the monitor, including the following items:
a) facility information, including a description of what should be expected if electricity to the monitor is
lost;
b) effects of lint, dust, sun, artificial light, heat or humidity;
c) effects and possible sources of electromagnetic (conducted and radiated) interference;
d) effects and causes of electrostatic discharge;
e) list of other devices that pose potential electrical problems;
f) effects of fluctuation(s) in electrical supply mains or battery voltage;
g) description of conditions of the sensors and electrodes, such as loosened electrodes, that can cause
environmental effects to be more pronounced;
h) other sources of interference;
i) steps that can be taken by the operator to identify and resolve environmental interference.
6 © ISO 2005 – All rights reserved

ISO 18778:2005(E)
8) Service information
 the recommended methods and frequency of routine inspection, testing, calibration, repair and periodic
service;
 a list of facilities that provide service, and their locations;
 expected service life of the monitor;
 shelf life and expected service life of sensors;
 information concerning the disposal of the monitor or components thereof.
6.8.3 Technical description
Additions:
aa) the technical description shall include the following:
 equipment specifications, including signal processing functions, algorithms and averaging times for
monitor functions that are applicable to the operation and use of the device;
 a statement as to whether or not pacemaker pulse rejection and defibrillator protection are included;
 a description of equipment required for monitor use and any specifications necessary for electrodes,
sensors, leads, cables, tubing, batteries and any other accessories;
 step-by-step procedures to prepare the monitor for initial and subsequent use;
 if a manual sensitivity control is provided, instructions as to when to use manual sensitivity and how to
adjust the control for optimal signal detection;
 step-by-step procedures recommended for determining whether the monitor is susceptible to the levels of
electromagnetic interference occurring at the use location, a recommendation to repeat the testing
periodically, and recommended action to take if the monitor fails the test;
 precautions and a schedule of maintenance and calibrations necessary.
6.101 Legibility
Safety indications shall be legible and correctly perceived by an individual with a visual acuity of 1 (corrected if
necessary) from a distance of 1 m at a range of illumination of 100 lx to 1 500 lx, when viewing the information,
markings, etc. perpendicular to and including 15° above, below, left and right of the normal line of sight of the
operator.
7 Power input
IEC 60601-1:1988, Clause 7 applies.
8 Basic safety categories
IEC 60601-1:1988, Clause 8 applies.
ISO 18778:2005(E)
9 Removable protective means
IEC 60601-1:1988, Clause 9 applies.
10 Environmental conditions
IEC 60601-1:1988, Clause 10 applies, except as follows:
10.1 Transport and storage
Replacement:
The monitor (not including the battery) shall be capable, while packed for transport and storage, of being
exposed to an environmental temperature range of − 40°C to + 70°C and at relative humidity up to 95 %,
non-condensing.
After such an exposure, the monitor shall meet the requirements of this International Standard and shall
remain operational.
10.2.1 Environment
Replacements:
a) an ambient temperature range of + 5 °C to + 40 °C;
b) a relative humidity range of 15 % to 95 %, non-condensing.
10.2.2 * Power supply
When mains-powered, the monitor shall operate within specification (± 20 % nominal).
Addition:
10.3 Disposal
Consideration should be given to the disposal of packaging wastes.
11 Not used
IEC 60601-1:1988, Clause 11 applies.
12 Not used
IEC 60601-1:1988, Clause 12 applies.
13 General
IEC 60601-1:1988, Clause 13 applies.
8 © ISO 2005 – All rights reserved

ISO 18778:2005(E)
14 Requirements related to classification
IEC 60601-1:1988, Clause 14 applies.
15 Limitation of voltage and/or energy
IEC 60601-1:1988, Clause 15 applies.
16 Enclosures and protective covers
IEC 60601-1:1988, Clause 16 applies.
17 Separation
IEC 60601-1:1988, Clause 17 applies.
18 Protective earthing, functional earthing and potential equalization
IEC 60601-1:1988, Clause 18 applies.
19 Continuous leakage currents and patient auxiliary currents
IEC 60601-1:1988, Clause 19 applies.
20 Dielectric strength
IEC 60601-1:1988, Clause 20 applies.
21 Mechanical strength
IEC 60601-1:1988, Clause 21 applies, except as follows:
21.6 Portable and mobile equipment
Addition:
The monitor is considered to be a portable and mobile piece of equipment and shall be capable of
withstanding the stresses caused by rough handling.
Compliance is checked by the tests a) and b) of IEC 60601-1:1988, and its amendments and the following
additional tests:
c) mechanical shock
Test the monitor according to IEC 60068-2-32 shock test (free fall) with the following severity levels:
 height: 0,5 m;
 number of falls: 2 falls on each face.
ISO 18778:2005(E)
After each of these tests, the monitor shall perform within the manufacturer's specifications and meet the
requirements of this International Standard:
d) vibration resistance;
Test the monitor according to IEC 60068-2-64 broad-band random vibration test with the following severity
levels:
 frequency range: 10 Hz to 150 Hz;
2 2 2
 acceleration spectral density: 1 (m/s ) /Hz (g /Hz) from 10 Hz to 12 Hz, decreasing at a rate of 3 dB
per octave from 12 Hz to 150 Hz;
 duration: 30 min on each orthogonal axis.
During each of these tests, visually inspect the monitor. After each of these tests, the monitor shall perform
within the manufacturer's specification and meet the requirements of this International Standard.
22 Moving parts
IEC 60601-1:1988, Clause 22 applies.
23 Surfaces, corners and edges
IEC 60601-1:1988, Clause 23 applies.
24 Stability in normal use
IEC 60601-1:1988, Clause 24 applies.
25 Expelled parts
IEC 60601-1:1988, Clause 25 applies.
26 Vibration and noise
IEC 60601-1:1988, Clause 26 applies.
27 Pneumatic and hydraulic power
IEC 60601-1:1988, Clause 27 applies.
28 Suspended masses
IEC 60601-1:1988, Clause 28 appl
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