EN 60601-2-20:2009/A1:2016
(Amendment)Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Transportinkubatoren
Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base et les performances essentielles des incubateurs de transport pour nouveau-nés
Medicinska električna oprema - 2-20. del: Posebne zahteve za osnovno varnost in bistvene lastnosti prenosnih inkubatorjev - Dopolnilo A1 (IEC 60601-2-20:2009/A1:2016)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2017
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Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and
essential performance of infant transport incubators (IEC 60601-2-20:2009/A1:2016)
Medizinische elektrische Geräte - Teil 2-20: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Tranportinkubatoren
Appareils électromédicaux - Partie 2-20: Exigences particulières pour la sécurité de base
et les performances essentielles des incubateurs de transport pour nouveau-nés
Ta slovenski standard je istoveten z: EN 60601-2-20:2009/A1:2016
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 60601-2-20:2009/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2016
ICS 11.040.10
English Version
Medical electrical equipment - Part 2-20: Particular requirements
for the basic safety and essential performance of infant transport
incubators
(IEC 60601-2-20:2009/A1:2016)
Appareils électromédicaux - Partie 2-20: Exigences Medizinische elektrische Geräte - Teil 2-20: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des incubateurs de transport pour nouveau-nés wesentlichen Leistungsmerkmale von Tranportinkubatoren
(IEC 60601-2-20:2009/A1:2016) (IEC 60601-2-20:2009/A1:2016)
This amendment A1 modifies the European Standard EN 60601-2-20:2009; it was approved by CENELEC on 2016-06-03. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-20:2009/A1:2016 E
European foreword
The text of document 62D/1325/FDIS, future IEC 60601-2-20:2009/A1, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-20:2009/A1:2016.
The following dates are fixed:
(dop) 2017-06-16
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2019-12-16
• latest date by which the national standards conflicting with
the document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 60601-2-20:2009/A11:2011.
Endorsement notice
The text of the International Standard IEC 60601-2-20:2009/A1:2016 was approved by CENELEC as
a European Standard without any modification.
In the Bibliography of EN 60601-2-20:2009, the following note has to be added for the standard indicated :
ISO 80601-2-56 NOTE Harmonized as EN ISO 80601-2-56.
In the Bibliography of EN 60601-2-20:2009, the following note has to be deleted for the standard indicated:
ISO 21647 NOTE Harmonized as EN ISO 21647:2009 (not modified).
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
Publication Year Title EN/HD Year
In Annex ZA of EN 60601-2-20:2009, replace the existing reference to IEC 60601-1-2:2007 as follows:
IEC 60601-1-2 - Medical electrical equipment - EN 60601-1-2 2015
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
In Annex ZA of EN 60601-2-20:2009, delete IEC 60601-1-10:2007.
IEC 60601-2-20 ®
Edition 2.0 2016-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AM ENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-20: Particular requirements for the basic safety and essential performance
of infant transport incubators
Appareils électromédicaux –
Partie 2-20: Exigences particulières pour la sécurité de base et les performances
essentielles des incubateurs de transport pour nouveau-nés
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.10 ISBN 978-2-8322-3343-6
– 2 – IEC 60601-2-20:2009/AMD1:2016
© IEC 2016
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1325/FDIS 62D/1346/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
INTRODUCTION
Replace, in the second paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.1 Scope, object and related standards
201.1.3 * Collateral standards
Delete the asterisk (*) from the title.
Replace the second paragraph by the following text:
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3 and IEC 60601-1-10 do not
apply. All other published collateral standards in the IEC 60601-1 series apply as published.
IEC 60601-2-20:2009/AMD1:2016 – 3 –
© IEC 2016
201.1.4 Particular standards
Add an asterisk at the beginning of the title, as follows:
201.1.4 * Particular standards
Add the following paragraph at the end of this subclause:
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED TRANSPORT
INCUBATOR including the displayed value are considered to be not a CLINICAL THERMOMETER in
the sense of the particular standard ISO 80601-2-56.
201.2 Normative references
Replace “IEC 60601-1-2:2007” by “IEC 60601-1”.
Remove the reference to IEC 60601-1-10:2007.
201.3 Terms and definitions
Replace, in the first paragraph, “IEC 60601-1:2005” by “IEC 60601-1”.
201.3.204
BABY CONTROLLED TRANSPORT INCUBATOR
Remove the note at the end of the entry.
201.7.9.2.2 Warning and safety notices
Add, after the existing text, the following new text:
*k) a statement that the INFANT TRANSPORT INCUBATOR cannot differentiate between an
increase in core temperature with a cold skin (fever) and a low core and SKIN TEMPERATURE
(hypothermia), and a recommendation to monitor the temperature of the PATIENT.
201.12.1.109 * Accuracy of indication of relative humidity
Replace, in the first paragraph, the phrase “of actual measured value” by “relative humidity”.
202 Electromagnetic compatibility – Requirements and tests
Replace, in the first paragraph, “IEC 60601-1-2:2007” by “IEC 60601-1-2”.
202.6.2.3 Radiated RF electromagnetic fields
Replace the number, title and entire text by the following new subclause number, title and
text:
202.8.9 IMMUNITY TEST LEVELS
Addition:
– 4 – IEC 60601-2-20:2009/AMD1:2016
© IEC 2016
For radiated radio-frequency electromagnetic fields, the INFANT TRANSPORT INCUBATOR and/or
system
– shall continue to perform its intended function as specified by the MANUFACTURER at a level
up to 3 V/m for the frequency range of the collateral standard for EMC;
– for BASIC SAFETY and ESSENTIAL PERFORMANCE, Table 4 for EMERGENCY MEDICAL SERVICES
ENVIRONMENT applies (i.e. the system may fail to provide its intended function but shall not
create a safety HARM).
210 Requirements for the development of physiologic closed-loop controllers
Delete the entire Clause 210.
Add, before the annexes, the following new clause:
212 * Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment
IEC 60601-1-12 applies except as follows:
212.4.2.1 * Environmental conditions of transport and storage between uses
Subclause 4.2.1 of IEC 60601-1-12 does not apply.
212.4.2.2.1 Continuous operating conditions
Subclause 4.2.2.1 of IEC 60601-1-12 does not apply.
NOTE Subclause 201.5.3 of this standard applies instead.
212.4.2.2.2 Transient operating conditions
Subclause 4.2.2 of IEC 60601-1-12 does not apply.
NOTE Subclause 201.12.1.113 of this standard applies instead.
212.5 * Classification of ME EQUIPMENT and ME SYSTEMS
Clause 5 of IEC 60601-1-12 does not apply.
NOTE See the additional statement in the instructions for use required by 212.6.3.2 of this particular standard.
212.6.3.2 Additional requirements for an electrical power source
Addition:
The instructions for use shall contain a statement that the TRANSPORT INCUBATOR may only be
used with supply mains that is regularly checked for proper PE connection.
212.6.3.4 * Additional requirements for operating instructions
Subclause 6.3.4 of IEC 60601-1-12 does not apply.
IEC 60601-2-20:2009/AMD1:2016 – 5 –
© IEC 2016
212.6.3.5 *Additional requirements for ME EQUIPMENT messages
Subclause 6.3.5 of IEC 60601-1-12 does not apply.
212.7 * Protection against electrical HAZARDS from ME EQUIPMENT
Clause 7 of IEC 60601-1-12 does not apply.
212.8.1 * Additional requirements for ingress of water or particulate matter into ME
EQUIPMENT and ME SYSTEMS
Subclause 8.1 of IEC 60601-1-12 does not apply.
212.9 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 9 of IEC 60601-1-12 does not apply.
NOTE Clause 201.12.1.113 of this standard applies instead
Annex AA
(informative)
Particular guidance and rationale
Add, immediately after the annex title, the following new text and figure:
AA.1 Requirements and the safety concept of this standard
Compliance with the minimum safety requirements specified in this particular standard is
predominantly checked by measurement of physical quantities such as the temperature. In
most cases the spatial location of the measuring site or the temporal development of the
quantity is of interest. Therefore, the expert group of this standard considered it helpful to
provide a synopsis of the requirements of this standard. Hence, Figure AA.1 illustrates the
requirements and their schematic measuring sites or expected temporal development. The
requirements as given by their clauses are set in brackets.
– 6 – IEC 60601-2-20:2009/AMD1:2016
© IEC 2016
1 °C
(201.12.1.105)
1,5 °C (201.12.1.102)
(2,0 °C tilted )
C
D
M
Air: 1,0 °C
A B
Skin: 0,5 °C
(201.7.4.2)
Air range
SKIN TEMPERATURE ±1,5 °C (20 °C to 30 °C
Display
Skin range
SENSOR
±2,0 °C (10 °C to 20 °C
(201.15.4.2.2)
36,3 °C
±0,3 °C (201.12.1.106)
(201.12.1.103)
(201.12.2.101)
Setting of
CONTROL
TEMPERATURE
0,7 °C
(201.12.1.104)
THERMAL
CUT-OUT
(201.15.4.2.1)
Overshoot maximum
+2 °C (201.12.1.108)
±1 °C
(201.12.1.101)
Maximum surface t
...
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