SIST EN ISO 18778:2005
(Main)Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Devices are used for clinical and home care applications, very often without professional supervision. This standard applies to stand-alone devices, multi-parameter monitors as well as to monitoring systems with regard to the variables specified by the manufacturer for apnoea detection. This standard applies also to the accessories e.g. probes and cables necessary to apply the apnoea monitor to the patient.
Beatmungsgeräte - Überwachungsgeräte für Kleinkinder - Besondere Anforderungen (ISO 18778:2005)
IEC 60601 1:1988, Abschnitt 1, gilt mit folgenden Ausnahmen:
Änderungen (am Ende von 1.1 ergänzen):
1.1
Diese Internationale Norm legt Anforderungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Überwachungsgeräten fest, die zur Erkennung offenbar lebensbedrohlicher Ereignisse bei schlafenden oder ruhenden Kindern unter drei Jahren verwendet werden ). Diese Internationale Norm gilt für Geräte, die bei der häuslichen Pflege angewendet werden. Diese Überwachungsgeräte werden im Allgemeinen ohne ständige Überwachung durch Fachpersonal verwendet.
Diese Internationale Norm gilt auch für die Zusatzteile, z. B. Tastköpfe und Kabel, die zur Anlegung des Überwachungsgeräts am Patienten erforderlich sind.
Diese Internationale Norm gilt nicht für Überwachungsgeräte, die für die Verwendung in Einrichtungen des Gesundheitswesens vorgesehen sind.
Die Anforderungen dieser Internationalen Norm, die die Anforderungen von IEC 60601 1:1988 mit ihren Änderungen 1 (1991) und 2 (1995) ersetzen oder ändern, haben Vorrang gegenüber den entsprechenden allgemeinen Anforderungen.
1.4
Ergänzung:
ANMERKUNG Die Planung und Gestaltung von Produkten, die dieser Norm entsprechen, kann im Lebensablauf des Produkts Auswirkungen auf die Umwelt haben. Umweltgesichtspunkte werden in Anhang BB behandelt. Zusätzliche Gesichtspunkte der Umweltauswirkungen werden in ISO 14971 behandelt.
Matériel respiratoire - Moniteurs pour enfants - Exigences particulieres (ISO 18778:2005)
Respiratorna oprema - Monitorji za otroke - Posebne zahteve (ISO 18778:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 18778:2005
01-junij-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 particulieres (ISO 18778:2005)
Ta slovenski standard je istoveten z: EN ISO 18778:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 18778:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 18778:2005
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SIST EN ISO 18778:2005
EUROPEAN STANDARD
EN ISO 18778
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2005
ICS 11.040.10
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 28 January 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18778:2005: E
worldwide for CEN national Members.
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SIST EN ISO 18778:2005
EN ISO 18778:2005 (E)
Foreword
This document (EN ISO 18778:2005) has been prepared by Technical Committee CEN/TC 215 "Respiratory
and anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical
Committee ISO/TC 121 "Anaesthetic and respiratory equipment”.
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 August 2005, and conflicting national standards shall be withdrawn
at the latest by August 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 EU Directive(s).
For relationship with EU Directive(s), 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, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
2
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SIST EN ISO 18778:2005
EN ISO 18778:2005 (E)
ANNEX ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42 EEC Medical devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42 EEC 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 normative
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.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Medical devices
Clause(s)/Subclause(s) of this Essential Requirements (Ers) Qualifying remarks/Notes
International Standard of EU Directive 93/42/EEC
4 All
5 All
6 13, 13.2
6.1 13.1, 13.3, 13.4, 13.5
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
3
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SIST EN ISO 18778:2005
EN ISO 18778:2005 (E)
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
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
4
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SIST EN ISO 18778:2005
EN ISO 18778:2005 (E)
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
5
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SIST EN ISO 18778:2005
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SIST EN ISO 18778:2005
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
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SIST EN ISO 18778:2005
ISO 18778:2005(E)
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ii © ISO 2005 – All rights reserved
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SIST EN ISO 18778:2005
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
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SIST EN ISO 18778:2005
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
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SIST EN ISO 18778:2005
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 2005 – All rights reserved v
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SIST EN ISO 18778:2005
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.
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SIST EN ISO 18778:2005
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 2005 – All rights reserved 1
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SIST EN ISO 18778:2005
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
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SIST EN ISO 18778:2005
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 2005 – All rights reserved 3
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SIST EN ISO 18778:2005
ISO 18778:2005(E)
Additions:
aa) the manufacturer shall mark the monitor with a caution to refer the user or operator to the
accompanyin
...
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