IEC 60601-1-2:2001/AMD1:2004
(Amendment)Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Amendement 1 - Appareils électromédicaux - Partie 1-2: Règles générales de sécurité - Norme collatérale: Compatibilité électromagnétique - Exigences et essais
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INTERNATIONAL IEC
STANDARD 60601-1-2
AMENDMENT 1
2004-09
Amendment 1
Medical electrical equipment –
Part 1-2:
General requirements for safety –
Collateral standard:
Electromagnetic compatibility –
Requirements and tests
IEC 2004 Droits de reproduction réservés Copyright - all rights reserved
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale S
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
– 2 – 60601-1-2 Amend. 1 IEC:2004(E)
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, 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
62A/462/FDIS 62A/469/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 maintenance result date indicated on the IEC web site 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• withdrawn,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
This amendment contains a first series of revisions to IEC 60601-1-2 (second edition, 2001):
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral
standard: Electromagnetic compatibility – Requirements and tests.
This amendment deals primarily with requirements for EQUIPMENT and SYSTEMS that:
• comply with CISPR 11 Group 2 Class B except for the third harmonic of the fundamental
frequency;
• are for use by healthcare professionals;
• are not intended for sale to the general public; and
• are intended for use in domestic establishments or connected to the PUBLIC MAINS
NETWORK.
However, this amendment also includes several other corrections and additions to IEC
60601-1-2:2001.
To meet needs for change that were identified by users of this Collateral Standard, it was
necessary to amend the standard before the previously approved maintenance cycle date.
Page 6
INTRODUCTION
Delete, on page 7, the paragraph beginning “This second edition allows a risk analysis…”
60601-1-2 Amend. 1 IEC:2004(E) – 3 –
Page 8
2 Terminology and definitions
Replace the existing first paragraph with the following:
For the purposes of this Collateral Standard, the terms and definitions given in
IEC 60601-1:1988, IEC 60601-1-1:2000, IEC 60601-1-8:2003 and ISO 14971:2000 and the
following apply:
Delete definition 2.210 and change all occurrences of “ESSENTIAL PERFORMANCE” throughout
the document to normal font.
Replace the existing definition 2.212 with the following:
*2.212
FUNCTION (of an EQUIPMENT or SYSTEM)
clinically significant operation that the EQUIPMENT or SYSTEM is intended to perform in the
diagnosis, treatment or monitoring of a PATIENT
Add the following new definitions:
*2.227
PROFESSIONAL EQUIPMENT or SYSTEM
EQUIPMENT or SYSTEM for use by healthcare professionals and that is not intended for sale to
the general public
[IEV 161-05-05, modified]
2.228
TYPE A PROFESSIONAL EQUIPMENT or SYSTEM
PROFESSIONAL EQUIPMENT or SYSTEM that complies with CISPR 11 Group 2 Class B except for
the third harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM, in which case
the third harmonic complies with the Group 2 Class A electromagnetic radiation disturbance
limit
NOTE See 36.201.1 a) 6).
Page 11
3 General requirements
3.201.2 Essential performance
Replace the existing text of this subclause with the following:
Either the essential performance of the EQUIPMENT or SYSTEM shall be identified (see Annex
GGG for guidance on identifying the essential performance) or the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM shall be considered essential performance for the
purpose of IMMUNITY testing (see 36.202.1 j)). The essential performance shall be disclosed in
the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS or, if this identification
is not performed, by inspection of the documents to verify that the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM has been tested in accordance with 36.202.
– 4 – 60601-1-2 Amend. 1 IEC:2004(E)
Page 12
3.201.4 Non-medical electrical equipment
Remove the asterisk from the title and replace the existing text of this subclause with the
following:
Non-medical electrical equipment that is supplied as part of a SYSTEM is exempt from the EMC
testing requirements of this standard, provided all of the following conditions are met (see
also Annex HHH):
a) the non-medical electrical equipment complies with applicable international EMC
standards;
b) both the EMISSIONS and IMMUNITY of the non-medical electrical equipment have been
determined not to adversely affect the essential performance or safety of the SYSTEM;
c) the EMISSIONS of the non-medical electrical equipment have been determined not to cause
the EMISSIONS of the SYSTEM to exceed applicable limits.
Compliance is checked by inspection of the documents for this determination and other
appropriate documents or certificates or, if this determination is not performed, by inspection
of the documents to verify that the non-medical electrical equipment has been tested in
accordance with this standard.
Add the following new subclause:
*3.201.5 General test conditions
For EMC testing, the SINGLE FAULT CONDITION requirements of the General Standard do not
apply.
Page 13
6.8.201 ACCOMPANYING DOCUMENTS
Renumber this subclause as follows:
6.8 ACCOMPANYING DOCUMENTS
6.8.2.201 Instructions for use
Add the following item:
*d) Requirements applicable to TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
If a TYPE A PROFESSIONAL EQUIPMENT or SYSTEM is intended for use in domestic
establishments or connection to the PUBLIC MAINS NETWORK (see 36.201.1 a) 6)), the
instructions for use shall include the following warning or equivalent:
Warning
This equipment/system is intended for use by healthcare professionals only. This
equipment/system may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as re-
orienting or relocating the [EQUIPMENT or SYSTEM] or shielding the location.
where “[EQUIPMENT or SYSTEM]” shall be replaced with the MODEL or TYPE REFERENCE of the
EQUIPMENT or SYSTEM.
60601-1-2 Amend. 1 IEC:2004(E) – 5 –
6.8.3.201 Technical description
a) Requirements applicable to all EQUIPMENT and SYSTEMS
Replace, on page 14, the existing item a) 3) with the following:
,
3) 4)
*3) Table 201, with the modifications specified below. The flowchart in Figure 201 is
the requirement in step-by-step graphical form for completion of Table 201 for
CISPR 11 EQUIPMENT and SYSTEMS. The flowchart in Figure 202 is the requirement in
step-by-step graphical form for completion of Table 201 for CISPR 14 and CISPR 15
EQUIPMENT.
– For CISPR 11 EQUIPMENT and SYSTEMS, “[EQUIPMENT or SYSTEM]” shall be replaced
with the MODEL OR TYPE REFERENCE of the EQUIPMENT or SYSTEM.
– For CISPR 14 and CISPR 15 EQUIPMENT, “[EQUIPMENT]” shall be replaced with the
MODEL OR TYPE REFERENCE of the EQUIPMENT.
– For CISPR 11 Group 1 EQUIPMENT and SYSTEMS, rows 5, 12 and 13 shall be
deleted.
– For CISPR 11 Group 2 EQUIPMENT and SYSTEMS, rows 4, 12 and 13 shall be
deleted.
– For EQUIPMENT that complies with CISPR 14-1, rows 4 through 6 and row 13 shall
be deleted
– For EQUIPMENT that complies with CISPR 15, rows 4 through 6 and row 12 shall be
deleted.
– For CISPR 11 EQUIPMENT and SYSTEMS that comply with Class A, including TYPE A
PROFESSIONAL EQUIPMENT and SYSTEMS, “[A or B]” in column 2 of row 6 shall be
replaced with “A.” For CISPR 11 EQUIPMENT and SYSTEMS that comply with Class B,
“[A or B]” shall be replaced with “B.”
– For EQUIPMENT and SYSTEMS that comply with IEC 61000-3-2, “[Class A, B, C, D, or
Not applicable]” in column 2 of row 7 shall be replaced with the class of the
EQUIPMENT or SYSTEM according to IEC 61000-3-2. For EQUIPMENT and SYSTEMS
that comply with IEC 61000-3-3, “[Complies or Not applicable]” in column 2 of row
8 shall be replaced with “Complies.” For EQUIPMENT and SYSTEMS for which IEC
61000-3-2 and IEC 61000-3-3 are not applicable, “[Class A, B, C, D, or Not
applicable]” and “[Complies or Not applicable]” shall each be replaced with “Not
applicable.”
– For CISPR 11 EQUIPMENT and SYSTEMS, column 3 of rows 6, 7 and 8 shall be
merged into one cell. For CISPR 11 EQUIPMENT and SYSTEMS that comply with
Class B and with IEC 61000-3-2 and IEC 61000-3-3, the text in column 3 of row 9
shall be moved into the merged cell. For TYPE A PROFESSIONAL EQUIPMENT and
SYSTEMS for which use in a domestic establishment or connection to the PUBLIC
MAINS NETWORK is intended and justified (see 6.8.3.201 j) and 36.201.1 a) 6)) and
that comply with IEC 61000-3-2 and IEC 61000-3-3, the text in column 3 of row 10
shall be moved into the merged cell. For CISPR 11 EQUIPMENT and SYSTEMS for
which IEC 61000-3-2 and IEC 61000-3-3 are not applicable or that comply with
Class A but do not meet the requirements for TYPE A PROFESSIONAL EQUIPMENT and
SYSTEMS specified in 36.201.1 a) 6), the text in column 3 of row 11 shall be moved
into the merged cell.
– For CISPR 14 or CISPR 15 EQUIPMENT, column 3 of rows 7 and 8 shall be merged
into one cell. For CISPR 14 or CISPR 15 EQUIPMENT that comply with IEC
61000-3-2 and with IEC 61000-3-3, the text in column 3 of row 9 shall be moved
into the merged cell. For CISPR 14 or CISPR 15 EQUIPMENT for which IEC
61000-3-2 and IEC 61000-3-3 are not applicable, the text in column 3 of row 11
shall be moved into the merged cell.
———————
3)
See Annex BBB for examples. These modifications should be performed in the order in which they appear.
4)
Row numbers refer to those in Table 201 before modifications are made.
– 6 – 60601-1-2 Amend. 1 IEC:2004(E)
– For EQUIPMENT and SYSTEMS specified for use only in a shielded location and for
which the electromagnetic radiation disturbance allowance or the mains terminal
disturbance voltage allowance in 36.201.1 a) 4) is used, the text specified by
6.8.3.201 c) 2) shall be added.
– Rows 9, 10 and 11 shall be deleted.
– The row numbers shall be deleted.
Add, on page 15, the following new item a) 7):
7) The performance of the EQUIPMENT or SYSTEM that was determined to be essential
performance.
Page 18
h) Requirements applicable to LARGE, PERMANENTLY-INSTALLED EQUIPMENT and SYSTEMS
Replace the first paragraph of this item with the following:
For LARGE, PERMANENTLY-INSTALLED EQUIPMENT and SYSTEMS for which the exemption
specified in 36.202.3 b) 9) is used, the ACCOMPANYING DOCUMENTS shall include the
following information:
i) Requirements applicable to EQUIPMENT and SYSTEMS found by a risk analysis to have no
essential performance
In the title of item i) and in 1) and 2), delete “by a risk analysis”.
Page 19
Add the following new item:
*j) Requirements applicable to TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
For TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS intended for use in domestic
establishments or connection to the PUBLIC MAINS NETWORK (see 36.201.1 a) 6)), the
ACCOMPANYING DOCUMENTS shall include a justification for not complying with the
CISPR 11 Group 2 Class B electromagnetic radiation disturbance limit at the third
harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM. This justification shall
be based on significant physical, technological or physiological limitations that prevent
compliance. The ACCOMPANYING DOCUMENTS shall also include a justification why the
EQUIPMENT or SYSTEM needs to be used in domestic establishments or connected to the
PUBLIC MAINS NETWORK.
Compliance is checked by inspection.
60601-1-2 Amend. 1 IEC:2004(E) – 7 –
Page 19
Replace the existing Table 201 with the following:
Table 201 – Guidance and manufacturer’s declaration – electromagnetic emissions –
for all EQUIPMENT and SYTEMS (see 6.8.3.201 a) 3))
Row
Guidance and manufacturer’s declaration – electromagnetic emissions
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The
customer or the user of the [EQUIPMENT or SYSTEM] should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The [EQUIPMENT or SYSTEM] uses RF energy only for
RF emissions
its internal function. Therefore, its RF emissions are
Group 1
very low and are not likely to cause any interference
CISPR 11
in nearby electronic equipment.
The [EQUIPMENT or SYSTEM] must emit electro-
RF emissions
magnetic energy in order to perform its intended
Group 2
function. Nearby electronic equipment may be
CISPR 11
affected.
RF emissions
6 Class [A or B]
CISPR 11
Harmonic emissions
[Class A, B, C, D,
or Not applicable]
IEC 61000-3-2
Voltage fluctuations/
[Complies or Not
flicker emissions
applicable]
IEC 61000-3-3
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments, including domestic establishments
[See 6.8.3.201 a)
9 and those directly connected to the public low-voltage
3) and Figure 201]
power supply network that supplies buildings used for
domestic purposes.
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments other than domestic, and may be used
in domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
[See 6.8.3.201 a)
Warning: This equipment/system is intended for
3) and Figure 201]
use by healthcare professionals only. This
equipment/ system may cause radio interference or
may disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures,
such as re-orienting or relocating the [EQUIPMENT or
SYSTEM] or shielding the location.
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments other than domestic and those directly
[See 6.8.3.201 a)
connected to the public low-voltage power supply
3) and Figure 201]
network that supplies buildings used for domestic
purposes.
RF emissions
The [EQUIPMENT] is not suitable for interconnection
Complies
with other equipment.
CISPR 14-1
RF emissions
The [EQUIPMENT] is not suitable for interconnection
13 Complies
with other equipment.
CISPR 15
– 8 – 60601-1-2 Amend. 1 IEC:2004(E)
Page 20
Replace the existing Figure 201 with the following:
Start
for CISPR 11 EQUIPMENT
and SYSTEMS
Replace "[EQUIPMENT or SYSTEM]" with the MODEL
OR TYPE REFERENCE of the EQUIPMENT or SYSTEM
Group 2 Group 1
Delete rows 4, 12 and 13
Delete rows 5, 12 and 13
Group?
from Table 201* from Table 201*
A**
B
Replace "[A or B]"
Replace "[A or B]"
Class?
with "A"
with "B"
Complies Not applicable
IEC 61000-3-2 and
61000-3-3 compliance?
Replace "[Class A, B, C, D, or Not
Replace "[Class A, B, C, D, or Not applicable]"
applicable]" in row 7 with the IEC 61000-3-2
in row 7 and "[Complies or Not applicable]" in
class and replace "[Complies or Not
row 8 with "Not applicable"*
applicable]" in row 8 with "Complies"*
Merge cells in column
Merge cells in column
3 of rows 6, 7 and 8*
3 of rows 6, 7 and 8*
TYPE A PROFESSIONAL EQUIPMENT
No
or SYSTEM intended and justified
for domestic or PUBLIC MAINS
A**
Class?
use?
B
Yes
Move text from column 3 Move text from column 3 Move text from column 3
of row 10 into merged cell*
of row 9 into merged cell* of row 11 into merged cell*
Specified for use Yes Allowance in
Yes
only in a shielded
36.201.1 a) 4) used?
location?
Add text specified
by 6.8.3.201 c) 2)
No
No
Delete rows 9, 10 and 11*
Delete row numbers * Row numbers refer to those in Table 201
before modifications are made.
** Including TYPE A PROFESSIONAL
End
EQUIPMENT and SYSTEMS
IEC 1258/04
Figure 201 – Instructions for completing Table 201
for CISPR 11 EQUIPMENT and SYSTEMS
(see 6.8.3.201 a) 3))
60601-1-2 Amend. 1 IEC:2004(E) – 9 –
Page 21
Replace the existing Figure 202 with the following:
Start
Start
for CISPR 15
for CISPR 14
EQUIPMENT
EQUIPMENT
Replace "[EQUIPMENT]" with the
Replace "[EQUIPMENT]" with the
MODEL OR TYPE REFERENCE of MODEL OR TYPE REFERENCE of the
EQUIPMENT EQUIPMENT
the
Delete rows 4 through 6 and
Delete rows 4 through 6 and
row 13 from Table 201*
row 12 from Table 201*
Complies Not applicable
IEC 61000-3-2 and
61000-3-3
compliance?
Replace "[Class A, B, C, D, or Not
Replace "[Class A, B, C, D, or Not applicable]"
applicable]" in row 7 with the IEC 61000-3-2
in row 7 and "[Complies or Not applicable]" in
class and replace "[Complies or Not
row 8 with "Not applicable"*
applicable]" in row 8 with "Complies"*
Merge cells in column 3 Merge cells in column 3
of rows 7 and 8* of rows 7 and 8*
Move text from column 3 of
Move text from column 3 of
row 9 into merged cell* row 10 into merged cell*
Delete rows 9, 10 and 11*
Delete row numbers
* Row numbers refer to those in Table 201
End
before modifications are made.
IEC 1259/04
Figure 202 – Instructions for completing Table 201
for CISPR 14 and CISPR 15 EQUIPMENT
(see 6.8.3.201 a) 3))
– 10 – 60601-1-2 Amend. 1 IEC:2004(E)
Page 22
In Table 202, replace “differential mode” with “line(s) to line(s)” and “common mode” with
“line(s) to earth”.
Page 32
36 ELECTROMAGNETIC COMPATIBILITY
36.201 Emissions
36.201.1 Protection of radio services
*a) Requirements
Replace, in the last line of the first paragraph of this item, “4) and 5)” with “4), 5) and 6)”.
Page 33
Renumber the existing item a) 6) as a) 7) and insert the following new item a) 6) in this
subclause:
*6) TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
CISPR 11 Group 2 PROFESSIONAL EQUIPMENT and SYSTEMS that are intended for use in
domestic establishments or connection to the PUBLIC MAINS NETWORK shall comply with
CISPR 11 Group 2 Class B, with the exception that the third harmonic of the fundamental
frequency of the EQUIPMENT or SYSTEM may comply with the CISPR 11 Group 2 Class A
electromagnetic radiation disturbance limit, provided this is justified based on:
– significant physical, technological or physiological limitations that prevent compliance
with the CISPR 11 Group 2 Class B electromagnetic radiation disturbance limit at the
third harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM and
– the need for the use of the EQUIPMENT or SYSTEM in domestic establishments or
connected to the PUBLIC MAINS NETWORK.
(See 6.8.2.201 d) and 6.8.3.201 j).)
b) Tests
Replace, in the first paragraph, “1) and 2) below” with “1), 2) and 3) below”.
Replace, in Footnote 10, “CISPR 11:1997” with “CISPR 11: 2003”.
Page 34
36.202 IMMUNITY
36.202.1 General
Replace, on page 35, the existing item d) with the following:
*d) Non-medical electrical equipment
Non-medical electrical equipment that is supplied as part of a SYSTEM is exempt from the
IMMUNITY testing requirements of this standard, provided all of the following conditions are
met (see also Annex HHH):
60601-1-2 Amend. 1 IEC:2004(E) – 11 –
– the non-medical electrical equipment complies with applicable international IMMUNITY
13)
standards;
– both the EMISSIONS and IMMUNITY of non-medical electrical equipment used in a SYSTEM
have been determined not to adversely affect the essential performance or safety of
the SYSTEM.
Replace, on page 36, the existing item h) with the following:
*h) Testing of normally non-observable FUNCTIONS
If a FUNCTION associated with essential performance (e.g. HIGH PRIORITY and MEDIUM
PRIORITY ALARM CONDITIONS) cannot normally be observed or verified during the test, a
method shall be provided (e.g. display of internal parameters) for determining compliance.
The use of special software or hardware may be needed.
Replace, on page 36, the ninth and tenth dashes of item j) with the following:
– noise on a waveform in which the noise would interfere with diagnosis, treatment or
monitoring;
– artefact or distortion in an image in which the artefact would interfere with diagnosis,
treatment or monitoring;
Page 37
36.202.3 Radiated RF electromagnetic fields
b) Tests
7) Test conditions for EQUIPMENT and SYSTEMS with a receiving section for RF
electromagnetic energy:
Replace, on page 39, the existing paragraph of this item with the following:
The receiving section of the EQUIPMENT or SYSTEM shall be tuned to the preferred
frequency of reception. If the receiving section of the EQUIPMENT or SYSTEM has no
preferred frequency of reception, the receiving section of the EQUIPMENT or SYSTEM
shall be tuned to the centre of the frequency range from which the frequency of
reception can be selected, except for spread spectrum receivers, which shall be
allowed to operate normally.
Page 41
36.202.5 Surges
*a) Requirements
Replace, in the second line of the first paragraph of this item, “ground” with “earth”.
*b) Tests
Replace, in 3) and 4) of this item, “ground” with “earth”. Replace, in 4) of this item, “grounded”
with “earthed”.
———————
13)
For example see CISPR 24 for ITE and IEC 61326-1 for measurement, control and laboratory equipment.
– 12 – 60601-1-2 Amend. 1 IEC:2004(E)
Page 42
36.202.6 Conducted disturbances, induced by RF fields
b) Tests
9) Test conditions for EQUIPMENT and SYSTEMS with a receiving section for RF
electromagnetic energy:
Replace, on page 45, the existing paragraph of this item with the following:
The receiving section of the EQUIPMENT or SYSTEM shall be tuned to the preferred
frequency of reception. If the receiving section of the EQUIPMENT or SYSTEM has no
preferred frequency of reception, the receiving section of the EQUIPMENT or SYSTEM
shall be tuned to the centre of the frequency range from which the frequency of
reception can be selected, except for spread spectrum receivers, which shall be
allowed to operate normally.
Page 48
Annex AAA – General guidance and rationale
Subclause 2.212
Add, on page 49, after the second dash, the following paragraph:
In this definition, “intended” means intended by the manufacturer of the EQUIPMENT or SYSTEM
and relates to the intended use / intended purpose of the EQUIPMENT or SYSTEM.
Subclause 2.225
Add, on page 50, the following new second paragraph:
EQUIPMENT and SYSTEMS are not connected to the PUBLIC MAINS NETWORK if they are used in
locations, e.g. hospitals, in which the mains connection is isolated from the public low-voltage
power supply network by transformers or substations.
Add, on page 50, the following new subclause:
Subclause 2.227
The IEV definition has been modified in this standard by replacing “equipment” with
“EQUIPMENT or SYSTEM”, replacing “in trades, professions or industries” with “by healthcare
professionals”, replacing “which” with “that” and deleting the NOTE. The NOTE was deleted
because while TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS that are intended for use in
domestic establishments or connected to the PUBLIC MAINS NETWORK must be identified as
intended for use by healthcare professionals, they are not required to be identified as
“professional equipment”.
The scope of “for use by healthcare professionals” is narrower than that of “under medical
supervision”. “PROFESSIONAL EQUIPMENT or SYSTEM” in this amendment restricts the
applicability of the allowance specified in 36.201.1 a) 6) to EQUIPMENT and SYSTEMS dir
...
NORME CEI
INTERNATIONALE
IEC
60601-1-2
INTERNATIONAL
STANDARD
AMENDEMENT 1
AMENDMENT 1
2004-09
Amendement 1
Appareils électromédicaux –
Partie 1-2:
Règles générales de sécurité –
Norme collatérale:
Compatibilité électromagnétique –
Exigences et essais
Amendment 1
Medical electrical equipment –
Part 1-2:
General requirements for safety –
Collateral standard:
Electromagnetic compatibility –
Requirements and tests
IEC 2005 Droits de reproduction réservés Copyright - all rights reserved
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
S
Commission Electrotechnique Internationale
PRICE CODE
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue
– 2 – 60601-1-2 Amend. 1 CEI:2005
AVANT-PROPOS
Cet amendement a été préparé par le sous-comité 62A: Aspects généraux des équipements
électriques utilisés en pratique médicale, du Comité d'Études 62 de la CEI: Équipements
électriques dans la pratique médicale.
Cette version bilingue (2005-09) remplace la version monolingue anglaise.
Le texte anglais de cet amendement est basé sur les documents 62A/462/FDIS et
62A/469/RVD. Le rapport de vote 62A/469/RVD donne toute information sur le vote ayant
abouti à l’approbation de cet amendement.
La version française de cet amendement n’a pas été soumise au vote.
Le comité a décidé que le contenu de cet amendement ainsi que celui de la publication de
base resteront inchangés jusqu'à la date de maintenance indiquée sur le site web de la CEI à
l'adresse http://webstore.iec.ch par les informations spécifiques relatives à la publication. A
cette date, la publication sera
• reconduite;
• supprimée;
• remplacée par une édition révisée, ou
• amendée.
_____________
INTRODUCTION
Cet amendement contient une première série de révisions de la CEI 60601-1-2 (deuxième
édition, 2001): Appareils électromédicaux – Partie 1-2: Règles générales de sécurité – Norme
collatérale: Compatibilité électromagnétique – Prescriptions et essais.
Cet amendement traite principalement des exigences relatives aux APPAREILS et aux
SYSTEMES qui:
– sont conformes à la Classe B, Groupe 2, du CISPR 11 sauf pour le troisième harmonique
de la fréquence fondamentale;
– sont utilisés par des professionnels de la santé;
– ne sont pas prévus pour être vendus au grand public; mais
– sont prévus pour être utilisés dans des locaux domestiques ou reliés au RESEAU
ELECTRIQUE PUBLIC.
Toutefois, cet amendement inclut également plusieurs autres corrections et adjonctions à la
CEI 60601-1-2:2001.
Afin de répondre aux besoins d'évolution identifiés par les utilisateurs de cette norme
collatérale, il a été nécessaire d'amender la norme avant la date initialement approuvée pour
sa maintenance.
60601-1-2 Amend. 1 IEC:2005 – 3 –
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, of IEC technical committee 62: Electrical equipment in
medical practice.
This bilingual version (2005-09) replaces the English version.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/462/FDIS 62A/469/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 French version of this amendment fas not been voted upon.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the maintenance result date indicated on the IEC web site 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
This amendment contains a first series of revisions to IEC 60601-1-2 (second edition, 2001):
Medical electrical equipment – Part 1-2: General requirements for safety – Collateral
standard: Electromagnetic compatibility – Requirements and tests.
This amendment deals primarily with requirements for EQUIPMENT and SYSTEMS that:
• comply with CISPR 11 Group 2 Class B except for the third harmonic of the fundamental
frequency;
• are for use by healthcare professionals;
• are not intended for sale to the general public; and
• are intended for use in domestic establishments or connected to the PUBLIC MAINS
.
NETWORK
However, this amendment also includes several other corrections and additions to IEC
60601-1-2:2001.
To meet needs for change that were identified by users of this Collateral Standard, it was
necessary to amend the standard before the previously approved maintenance cycle date.
– 4 – 60601-1-2 Amend. 1 CEI:2005
Page 12
INTRODUCTION
Supprimer, à la page 14, l'alinéa, commençant par "Cette deuxième édition permet de mettre
en oeuvre une analyse des risques.".
Page 16
2 Terminologie et définitions
Remplacer le premier alinéa existant par ce qui suit:
Pour les besoins de la présente norme collatérale, les termes et définitions donnés dans la
CEI 60601-1:1988, la CEI 60601-1-1:2001, la CEI 60601-1-8:2003 et dans l’ISO 14971:2000,
ainsi que les définitions suivantes s'appliquent.
Supprimer la définition 2.210 et changer toutes les occurrences de "PERFORMANCE
ESSENTIELLE" en police normale.
Remplacer la définition 2.212 existante par la suivante:
*2.212
FONCTION (d'un APPAREIL ou d'un SYSTEME )
opération cliniquement significative pour laquelle un APPAREIL ou un SYSTEME est prévu à des
fins de diagnostic, de traitement ou de surveillance d'un PATIENT
Ajouter les nouvelles définitions suivantes:
*2.227
APPAREIL ou SYSTEME PROFESSIONNEL
APPAREIL ou SYSTEME utilisé par les professionnels de santé et qui n'est pas destiné à être vendu au
grand public
[VEI 161-05-05, modifié]
*2.228
APPAREIL ou SYSTEME PROFESSIONNEL de TYPE A
APPAREIL PROFESSIONNEL ou SYSTEME qui est conforme à la CISPR 11, groupe 2, classe B, sauf pour
le troisième harmonique de la fréquence fondamentale de l'APPAREIL ou du SYSTEME, lequel troisième
harmonique respecte les limites pour les perturbations électromagnétiques rayonnées du groupe 2,
classe A
NOTE Voir 36.201.1 a) 6).
60601-1-2 Amend. 1 IEC:2005 – 5 –
Page 13
INTRODUCTION
Delete, on page 15, the paragraph beginning “This second edition allows a risk analysis…”
Page 17
2 Terminology and definitions
Replace the existing first paragraph with the following:
For the purposes of this Collateral Standard, the terms and definitions given in
IEC 60601-1:1988, IEC 60601-1-1:2000, IEC 60601-1-8:2003 and ISO 14971:2000 and the
following apply:
Delete definition 2.210 and change all occurrences of “ESSENTIAL PERFORMANCE” throughout
the document to normal font.
Replace the existing definition 2.212 with the following:
*2.212
FUNCTION (of an EQUIPMENT or SYSTEM)
clinically significant operation that the EQUIPMENT or SYSTEM is intended to perform in the
diagnosis, treatment or monitoring of a PATIENT
Add the following new definitions:
*2.227
PROFESSIONAL EQUIPMENT or SYSTEM
EQUIPMENT or SYSTEM for use by healthcare professionals and that is not intended for sale to
the general public
[IEV 161-05-05, modified]
2.228
TYPE A PROFESSIONAL EQUIPMENT or SYSTEM
PROFESSIONAL EQUIPMENT or SYSTEM that complies with CISPR 11 Group 2 Class B except for
the third harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM, in which case
the third harmonic complies with the Group 2 Class A electromagnetic radiation disturbance
limit
NOTE See 36.201.1 a) 6).
– 6 – 60601-1-2 Amend. 1 CEI:2005
Page 24
3 Exigences générales
3.201.2 Performance essentielle
Remplacer le texte existant de ce paragraphe par ce qui suit:
Les performances essentielles des APPAREILS et des SYSTEMES doivent être identifiées (voir
l'Annexe GGG qui donne des recommandations concernant la façon d'identifier les
performances essentielles). Cependant, si les performances essentielles ne sont pas
identifiées, toutes les caractéristiques de performances de toutes les FONCTIONS de l'APPAREIL
ou du SYSTEME doivent être considérées comme des performances essentielles pour les
essais d'IMMUNITE (voir 36.202.1 j)). Les caractéristiques identifiées comme étant des
performances essentielles doivent être listées dans les DOCUMENTS D'ACCOMPAGNEMENT.
La conformité est vérifiée par l'inspection des DOCUMENTS D'ACCOMPAGNEMENT ou, si cette
identification n'est pas effectuée, par l'inspection de tout document permettant de vérifier que
toutes les caractéristiques de performances de toutes les FONCTIONS de l'APPAREIL ou du
SYSTEME ont été testées selon 36.202.
3.201.4 Appareil non électromédical
Supprimer l’astérisque du titre et remplacer le texte existant de ce paragraphe par le suivant:
SYSTEME est dispensé des
Un appareil non électromédical fourni en tant qu'élément d'un
exigences d'essais CEM de cette norme, si toutes les conditions suivantes sont satisfaites
(voir également l'Annexe HHH):
a) l'appareil non électromédical est conforme aux normes internationales CEM applicables;
b) il a été déterminé que ni les EMISSIONS ni l'IMMUNITE de l'appareil non électromédical ne
compromettaient les performances essentielles ou la sécurité de base du SYSTEME;
c) il a été déterminé que les EMISSIONS de l'appareil non électromédical n'entraînaient pas le
dépassement des limites applicables pour les EMISSIONS du SYSTEME.
La conformité est vérifiée par l'inspection des documents nécessaires à cette détermination et
d'autres documents ou certificats appropriés ou, si cette détermination n'est pas effectuée
ainsi, par l'inspection des documents destinés à vérifier que l'appareil non électromédical a
été testé selon cette norme.
Ajouter le nouveau paragraphe suivant:
*3.201.5 Conditions générales d'essai
Les exigences de la norme générale relatives aux CONDITIONS DE PREMIER DEFAUT ne
s'appliquent pas aux essais CEM.
60601-1-2 Amend. 1 IEC:2005 – 7 –
Page 25
3 General requirements
3.201.2 Essential performance
Replace the existing text of this subclause with the following:
Either the essential performance of the EQUIPMENT or SYSTEM shall be identified (see Annex
GGG for guidance on identifying the essential performance) or the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM shall be considered essential performance for the
purpose of IMMUNITY testing (see 36.202.1 j)). The essential performance shall be disclosed in
the ACCOMPANYING DOCUMENTS.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS or, if this identification
is not performed, by inspection of the documents to verify that the performance of all
FUNCTIONS of the EQUIPMENT or SYSTEM has been tested in accordance with 36.202.
3.201.4 Non-medical electrical equipment
Remove the asterisk from the title and replace the existing text of this subclause with the
following:
SYSTEM is exempt from the EMC
Non-medical electrical equipment that is supplied as part of a
testing requirements of this standard, provided all of the following conditions are met (see
also Annex HHH):
a) the non-medical electrical equipment complies with applicable international EMC
standards;
b) both the EMISSIONS and IMMUNITY of the non-medical electrical equipment have been
determined not to adversely affect the essential performance or safety of the SYSTEM;
c) the EMISSIONS of the non-medical electrical equipment have been determined not to cause
EMISSIONS of the SYSTEM to exceed applicable limits.
the
Compliance is checked by inspection of the documents for this determination and other
appropriate documents or certificates or, if this determination is not performed, by inspection
of the documents to verify that the non-medical electrical equipment has been tested in
accordance with this standard.
Add the following new subclause:
*3.201.5 General test conditions
For EMC testing, the SINGLE FAULT CONDITION requirements of the General Standard do not
apply.
– 8 – 60601-1-2 Amend. 1 CEI:2005
Page 26
6.8.201 DOCUMENTS D'ACCOMPAGNEMENT
Renuméroter ce paragraphe comme suit :
6.8 DOCUMENTS D'ACCOMPAGNEMENT
6.8.2.201 Instructions d'utilisation
Ajouter le point suivant:
*d) Exigences applicables aux APPAREILS ou SYSTEMES PROFESSIONNELS de TYPE A
Lorsque des APPAREILS et des SYSTEMES PROFESSIONNELS sont prévus pour être utilisés
dans des locaux domestiques ou raccordés au RESEAU ELECTRIQUE PUBLIC (voir 36.201.1 a)
6)), les instructions d'utilisation doivent inclure l'avertissement suivant ou équivalent:
Attention
Cet appareil/système est réservé uniquement à l'usage des professionnels de la
santé. C'est un appareil/système médical de la Classe A, Groupe 2, du CISPR 11. Cet
appareil/système peut provoquer des interférences radio ou peut perturber le
fonctionnement des appareils situés à proximité. Il peut être nécessaire de prendre
des mesures palliatives adéquates, comme réorienter ou repositionner [l'APPAREIL ou
le SYSTEME] ou bien encore de blinder la pièce.
Le terme "[APPAREIL ou SYSTEME]" doit être remplacé par la REFERENCE DU MODELE ou
DU TYPE de l'APPAREIL ou du SYSTEME.
6.8.3.201 Description technique
a) Exigences applicables à tous les APPAREILS et SYSTEMES
Remplacer page 28, le point a) 3) existant de ce paragraphe par ce qui suit:
1 2
*3) Le Tableau 201, avec les modifications spécifiées ci-dessous. L'organigramme de
la Figure 201 est l’exigence étape par étape, sous forme graphique, relative à la mise
en oeuvre du Tableau 201, concernant les APPAREILS et les SYSTEMES du CISPR 11.
L'organigramme de la Figure 202 est l’exigence étape par étape, sous forme
graphique, relative à la mise en oeuvre du Tableau 201, concernant les APPAREILS des
CISPR 14 et CISPR 15.
– Pour les APPAREILS et les SYSTEMES du CISPR 11, "[l'APPAREIL ou le SYSTEME]" doit
être remplacé par la REFERENCE DU MODELE ou DU TYPE de l'APPAREIL ou du
SYSTEME.
– Pour les APPAREILS des CISPR 14 et CISPR 15 , "[l'APPAREIL]" doit être remplacé
par la REFERENCE DU MODELE ou DU TYPE de l'APPAREIL.
– Pour les APPAREILS et les SYSTEMES du CISPR 11 Groupe 1, les lignes 5, 12 et 13
doivent être supprimées.
– Pour les APPAREILS et les SYSTEMES du CISPR 11 Groupe 2, les lignes 4, 12 et 13
doivent être supprimées.
– Pour les APPAREILS qui satisfont au CISPR 14-1, les lignes 4 à 6 et la ligne 13
doivent être supprimées.
———————
Voir l’Annexe BBB pour des exemples. Il convient que ces modifications soient effectuées dans l’ordre dans
lequel elles apparaissent.
Les numéros des cellules indiqués sont ceux du Tableau 201 avant l’application des modifications.
60601-1-2 Amend. 1 IEC:2005 – 9 –
Page 27
6.8.201 ACCOMPANYING DOCUMENTS
Renumber this subclause as follows:
6.8 ACCOMPANYING DOCUMENTS
6.8.2.201 Instructions for use
Add the following item:
*d) Requirements applicable to TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
If a TYPE A PROFESSIONAL EQUIPMENT or SYSTEM is intended for use in domestic
establishments or connection to the PUBLIC MAINS NETWORK (see 36.201.1 a) 6)), the
instructions for use shall include the following warning or equivalent:
Warning
This equipment/system is intended for use by healthcare professionals only. This
equipment/system may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures, such as re-
orienting or relocating the [EQUIPMENT or SYSTEM] or shielding the location.
where “[EQUIPMENT or SYSTEM]” shall be replaced with the MODEL or TYPE REFERENCE of the
EQUIPMENT or SYSTEM.
6.8.3.201 Technical description
a) Requirements applicable to all EQUIPMENT and SYSTEMS
Replace, on page 29, the existing item a) 3) with the following:
,
1 2
*3) Table 201, with the modifications specified below. The flowchart in Figure 201 is the
requirement in step-by-step graphical form for completion of Table 201 for CISPR 11
EQUIPMENT and SYSTEMS. The flowchart in Figure 202 is the requirement in step-by-step
graphical form for completion of Table 201 for CISPR 14 and CISPR 15 EQUIPMENT.
– For CISPR 11 EQUIPMENT and SYSTEMS, “[EQUIPMENT or SYSTEM]” shall be replaced
with the MODEL OR TYPE REFERENCE of the EQUIPMENT or SYSTEM.
– For CISPR 14 and CISPR 15 EQUIPMENT, “[EQUIPMENT]” shall be replaced with the
MODEL OR TYPE REFERENCE of the EQUIPMENT.
– For CISPR 11 Group 1 EQUIPMENT and SYSTEMS, rows 5, 12 and 13 shall be
deleted.
– For CISPR 11 Group 2 EQUIPMENT and SYSTEMS, rows 4, 12 and 13 shall be
deleted.
– For EQUIPMENT that complies with CISPR 14-1, rows 4 through 6 and row 13 shall
be deleted
———————
See Annex BBB for examples. These modifications should be performed in the order in which they appear.
Row numbers refer to those in Table 201 before modifications are made.
– 10 – 60601-1-2 Amend. 1 CEI:2005
– Pour les APPAREILS qui satisfont au CISPR 15, les lignes 4 à 6 et la ligne 12
doivent être supprimées.
– Pour les APPAREILS et les SYSTEMES du CISPR 11 satisfaisant à la Classe A, y
compris les APPAREILS ou SYSTEMES PROFESSIONNELS de TYPE A, “[A ou B]” à la
colonne 2, ligne 6, doit être remplacé par “A”. Pour les APPAREILS et les SYSTEMES
du CISPR 11 qui satisfont à la Classe B, “[A ou B]” doit être remplacé par “B”.
– Pour les APPAREILS et les SYSTEMES satisfaisant à la CEI 61000-3-2, "[Classe A, B,
C, D ou Non applicable]” à la colonne 2, ligne 7, doit être remplacé par la classe de
l'APPAREIL ou du SYSTEME, selon la CEI 61000-3-2. Pour les APPAREILS et les
SYSTEMES satisfaisant à la CEI 61000-3-3, "[Conforme ou Non applicable]” à la
colonne 2, ligne 8, doit être remplacé par "Conforme". Pour les APPAREILS et les
SYSTEMES pour lesquels la CEI 61000-3-2 et la CEI 61000-3-3 ne sont pas
applicables, "[Classe A, B, C, D ou Non applicable]” et "[Conforme ou Non
applicable]”, doivent être remplacés par "Non applicable".
– Pour les APPAREILS et les SYSTEMES du CISPR 11, les cellules de la colonne 3, aux
lignes 6, 7 et 8 doivent être fusionnées en une seule. Pour les APPAREILS et les
SYSTEMES du CISPR 11 qui satisfont à la Classe B, à la CEI 61000-3-2 et à la
CEI 61000-3-3, le texte de la colonne 3, ligne 9 doit être déplacé dans la cellule
fusionnée. Pour les APPAREILS et les SYSTEMES PROFESSIONNELS de TYPE A
conformes à la CEI 61000-3-2 et à la CEI 61000-3-3 et pour lesquels l'utilisation
dans un local domestique ou le raccordement au RESEAU ELECTRIQUE PUBLIC est
prévu et justifié (voir 6.8.3.201 j) et 36.201.1 a) 6)), le texte à la colonne 3, ligne 10
doit être déplacé dans la cellule fusionnée. Pour les APPAREILS et les SYSTEMES du
CISPR 11 pour lesquels la CEI 61000-3-2 et la CEI 61000-3-3 ne sont pas
applicables ou qui sont conformes à la Classe A mais ne respectent pas les
exigences pour les APPAREILS ou SYSTEMES PROFESSIONNELS de TYPE A spécifiées
en 36.201.1 a) 6), le texte à la colonne 3, ligne 11, doit être déplacé dans la cellule
fusionnée.
– Pour les APPAREILS du CISPR 14 ou du CISPR 15, les cellules à la colonne 3,
lignes 7 et 8, doivent être fusionnées en une seule. Pour les APPAREILS du
CISPR 14 ou du CISPR 15 qui satisfont à la CEI 61000-3-2 et à la CEI 61000-3-3,
le texte à la colonne 3, ligne 9, doit être déplacé dans la cellule fusionnée. Pour
les APPAREILS du CISPR 14 ou du CISPR 15 pour lesquels la CEI 61000-3-2 et la
CEI 61000-3-3 ne sont pas applicables, le texte à la colonne 3, ligne 11, doit être
déplacé dans la cellule fusionnée.
– Pour les APPAREILS et les SYSTEMES dont l'utilisation est spécifiée uniquement dans
un emplacement blindé et pour lesquels la tolérance de la perturbation au
rayonnement électromagnétique ou la tolérance de la tension perturbatrice aux
bornes d'alimentation, mentionnée en 36.201.1 a) 4) est utilisée, le texte spécifié
par 6.8.3.201 c) 2) doit être ajouté.
– Les lignes 9, 10 et 11 doivent être supprimées.
– Les numéros de ligne doivent être supprimés.
Page 15
Ajouter, à la page 32, le nouveau point a) 7) suivant:
7) Une liste des caractéristiques de l'APPAREIL ou du SYSTEME qui ont été déterminées
comme étant des performances essentielles.
60601-1-2 Amend. 1 IEC:2005 – 11 –
– For EQUIPMENT that complies with CISPR 15, rows 4 through 6 and row 12 shall be
deleted.
– For CISPR 11 EQUIPMENT and SYSTEMS that comply with Class A, including TYPE A
PROFESSIONAL EQUIPMENT and SYSTEMS, “[A or B]” in column 2 of row 6 shall be
replaced with “A.” For CISPR 11 EQUIPMENT and SYSTEMS that comply with Class B,
“[A or B]” shall be replaced with “B.”
– For EQUIPMENT and SYSTEMS that comply with IEC 61000-3-2, “[Class A, B, C, D, or
Not applicable]” in column 2 of row 7 shall be replaced with the class of the
EQUIPMENT or SYSTEM according to IEC 61000-3-2. For EQUIPMENT and SYSTEMS
that comply with IEC 61000-3-3, “[Complies or Not applicable]” in column 2 of row
8 shall be replaced with “Complies.” For EQUIPMENT and SYSTEMS for which IEC
61000-3-2 and IEC 61000-3-3 are not applicable, “[Class A, B, C, D, or Not
applicable]” and “[Complies or Not applicable]” shall each be replaced with “Not
applicable.”
– For CISPR 11 EQUIPMENT and SYSTEMS, column 3 of rows 6, 7 and 8 shall be
merged into one cell. For CISPR 11 EQUIPMENT and SYSTEMS that comply with
Class B and with IEC 61000-3-2 and IEC 61000-3-3, the text in column 3 of row 9
shall be moved into the merged cell. For TYPE A PROFESSIONAL EQUIPMENT and
SYSTEMS for which use in a domestic establishment or connection to the PUBLIC
MAINS NETWORK is intended and justified (see 6.8.3.201 j) and 36.201.1 a) 6)) and
that comply with IEC 61000-3-2 and IEC 61000-3-3, the text in column 3 of row 10
shall be moved into the merged cell. For CISPR 11 EQUIPMENT and SYSTEMS for
which IEC 61000-3-2 and IEC 61000-3-3 are not applicable or that comply with
Class A but do not meet the requirements for TYPE A PROFESSIONAL EQUIPMENT and
SYSTEMS specified in 36.201.1 a) 6), the text in column 3 of row 11 shall be moved
into the merged cell.
– For CISPR 14 or CISPR 15 EQUIPMENT, column 3 of rows 7 and 8 shall be merged
into one cell. For CISPR 14 or CISPR 15 EQUIPMENT that comply with IEC
61000-3-2 and with IEC 61000-3-3, the text in column 3 of row 9 shall be moved
into the merged cell. For CISPR 14 or CISPR 15 EQUIPMENT for which IEC
61000-3-2 and IEC 61000-3-3 are not applicable, the text in column 3 of row 11
shall be moved into the merged cell.
– For EQUIPMENT and SYSTEMS specified for use only in a shielded location and for
which the electromagnetic radiation disturbance allowance or the mains terminal
disturbance voltage allowance in 36.201.1 a) 4) is used, the text specified by
6.8.3.201 c) 2) shall be added.
– Rows 9, 10 and 11 shall be deleted.
– The row numbers shall be deleted.
Add, on page 33, the following new item a) 7):
7) The performance of the equipment or system that was determined to be essential
performance.
– 12 – 60601-1-2 Amend. 1 CEI:2005
Page 38
h) Exigences applicables aux APPAREILS et SYSTEMES DE GRANDES DIMENSIONS INSTALLES DE
FAÇON PERMANENTE
Remplacer le premier paragraphe de ce point par le suivant:
Pour les APPAREILS et SYSTEMES DE GRANDES DIMENSIONS INSTALLES DE FAÇON PERMANENTE,
pour lesquels l'exemption spécifiée en 36.202.3 b) 9) est utilisée, les DOCUMENTS
D'ACCOMPAGNEMENT doivent inclure les informations suivantes:
i) Exigences applicables aux APPAREILS et aux SYSTEMES dont une analyse des risques révèle
qu'ils n'ont aucune PERFORMANCE ESSENTIELLE
Dans le titre du point i) et en 1) et 2), supprimer la mention "dont une analyse des risques".
Ajouter le nouveau point suivant:
*j) Exigences applicables aux APPAREILS et aux SYSTEMES PROFESSIONNELS de TYPE A
Lorsque des APPAREILS et des SYSTEMES PROFESSIONNELS sont prévus pour être utilisés
dans des locaux domestiques ou raccordés au RESEAU ELECTRIQUE PUBLIC (voir 36.201.1 a)
6)), les DOCUMENTS D'ACCOMPAGNEMENT doivent inclure une justification de ne pas
respecter les limites de perturbation électromagnétique rayonnée de la Classe B groupe 2
du CISPR 11 au troisième harmonique de la fréquence fondamentale de l'APPAREIL et du
SYSTEME. Cette justification doit être basée sur des limitations physiques, technologiques
et/ou physiologiques significatives qui empêchent la conformité. Les DOCUMENTS
D'ACCOMPAGNEMENT doivent aussi inclure une justification expliquant pourquoi il faut que
l'APPAREIL ou le SYSTEME soit utilisé dans des locaux domestiques ou soit connecté au
RESEAU ELECTRIQUE PUBLIC.
La conformité est vérifiée par inspection.
60601-1-2 Amend. 1 IEC:2005 – 13 –
Page 39
h) Requirements applicable to LARGE, PERMANENTLY-INSTALLED EQUIPMENT and SYSTEMS
Replace the first paragraph of this item with the following:
For LARGE, PERMANENTLY-INSTALLED EQUIPMENT and SYSTEMS for which the exemption
specified in 36.202.3 b) 9) is used, the ACCOMPANYING DOCUMENTS shall include the
following information:
i) Requirements applicable to EQUIPMENT and SYSTEMS found by a risk analysis to have no
essential performance
In the title of item i) and in 1) and 2), delete “by a risk analysis”.
Add the following new item:
*j) Requirements applicable to TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
For TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS intended for use in domestic
establishments or connection to the PUBLIC MAINS NETWORK (see 36.201.1 a) 6)), the
ACCOMPANYING DOCUMENTS shall include a justification for not complying with the
CISPR 11 Group 2 Class B electromagnetic radiation disturbance limit at the third
harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM. This justification shall
be based on significant physical, technological or physiological limitations that prevent
compliance. The ACCOMPANYING DOCUMENTS shall also include a justification why the
EQUIPMENT or SYSTEM needs to be used in domestic establishments or connected to the
PUBLIC MAINS NETWORK.
Compliance is checked by inspection.
– 14 – 60601-1-2 Amend. 1 CEI:2005
Page 40
Remplacer le Tableau 201 existant par le suivant:
Tableau 201 – Recommandations et déclaration du fabricant – émissions
électromagnétiques – pour tous les APPAREILS et SYSTEMES (voir 6.8.3.201 a) 3))
Ligne
Recommandations et déclaration du fabricant – émissions électromagnétiques
[l'APPAREIL ou le SYSTEME] est prévu pour être utilisé dans l'environnement électromagnétique spécifié ci-
dessous. Il convient que le client ou l'utilisateur de [l'APPAREIL ou du SYSTEME] s'assure qu'il est utilisé
dans un tel environnement.
3 Environnement électromagnétique –
Essai d'émissions Conformité
recommandations
[L'APPAREIL ou le SYSTEME] utilise de l'énergie RF
uniquement pour son fonctionnement interne. Par
Émissions RF
Groupe 1 conséquent, ses émissions RF sont très faibles et ne
CISPR 11
sont pas susceptibles de provoquer des interférences
dans un appareil électronique voisin.
[L'APPAREIL ou le SYSTEME] doit émettre de l'énergie
Émissions RF
électromagnétique pour réaliser la fonction pour
5 Groupe 2
laquelle il est prévu. Les appareils électroniques
CISPR 11
voisins peuvent être affectés.
Émissions RF
6 Classe [A ou B]
CISPR 11
Émissions
[Classe A, B, C, D,
7 d'harmoniques
ou Non applicable]
CEI 61000-3-2
Émissions de
fluctuations de tension/
8 [Conforme ou Non
de papillotement
applicable]
CEI 61000-3-3
[L'APPAREIL ou le SYSTEME] convient à l'utilisation
dans tous les établissements, y compris dans les
[Voir 6.8.3.201 a)
9 locaux domestiques et ceux directement reliés au
3) et Figure 201]
réseau public d'alimentation électrique basse tension,
alimentant des bâtiments à usage domestique.
[L'APPAREIL ou le SYSTEME] convient à l'utilisation
dans tous les établissements, autres que les locaux
domestiques, et peut être utilisé dans des locaux
domestiques et ceux directement reliés au réseau
public d'alimentation électrique basse tension,
alimentant des bâtiments à usage domestique, à
condition de considérer l'avertissement suivant:
[Voir 6.8.3.201 a)
Attention
3) et Figure 201]
Cet appareil/système est réservé uniquement à
l'usage des professionnels de la santé. Cet
appareil/système peut provoquer des interférences
radio ou peut perturber le fonctionnement des
appareils situés à proximité. Il peut être nécessaire
de prendre des mesures palliatives adéquates,
comme réorienter ou repositionner [l'APPAREIL ou le
SYSTEME] ou bien encore de blinder la pièce.
[L'APPAREIL ou le SYSTEME] convient à l'utilisation
dans tous les établissements, autres que les locaux
[Voir 6.8.3.201 a)
domestiques et ceux directement reliés au réseau
3) et Figure 201]
public d'alimentation électrique basse tension,
alimentant des bâtiments à usage domestique.
Émissions RF
[L'APPAREIL] n'est pas approprié pour être
Conforme
interconnecté avec d'autres appareils.
CISPR 14-1
Émissions RF
APPAREIL] n'est pas approprié pour être
[L'
Conforme
interconnecté avec d'autres appareils.
CISPR 15
60601-1-2 Amend. 1 IEC:2005 – 15 –
Page 41
Replace the existing Table 201 with the following:
Table 201 – Guidance and manufacturer’s declaration – electromagnetic emissions –
for all EQUIPMENT and SYTEMS (see 6.8.3.201 a) 3))
Row
Guidance and manufacturer’s declaration – electromagnetic emissions
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The
customer or the user of the [EQUIPMENT or SYSTEM] should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The [EQUIPMENT or SYSTEM] uses RF energy only for
RF emissions
its internal function. Therefore, its RF emissions are
Group 1
very low and are not likely to cause any interference
CISPR 11
in nearby electronic equipment.
The [EQUIPMENT or SYSTEM] must emit electro-
RF emissions
magnetic energy in order to perform its intended
Group 2
function. Nearby electronic equipment may be
CISPR 11
affected.
RF emissions
6 Class [A or B]
CISPR 11
Harmonic emissions
[Class A, B, C, D,
or Not applicable]
IEC 61000-3-2
Voltage fluctuations/
[Complies or Not
flicker emissions
applicable]
IEC 61000-3-3
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments, including domestic establishments
[See 6.8.3.201 a)
9 and those directly connected to the public low-voltage
3) and Figure 201]
power supply network that supplies buildings used for
domestic purposes.
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments other than domestic, and may be used
in domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
[See 6.8.3.201 a)
Warning: This equipment/system is intended for
3) and Figure 201]
use by healthcare professionals only. This
equipment/ system may cause radio interference or
may disrupt the operation of nearby equipment. It
may be necessary to take mitigation measures,
such as re-orienting or relocating the [EQUIPMENT or
SYSTEM] or shielding the location.
The [EQUIPMENT or SYSTEM] is suitable for use in all
establishments other than domestic and those directly
[See 6.8.3.201 a)
connected to the public low-voltage power supply
3) and Figure 201]
network that supplies buildings used for domestic
purposes.
RF emissions
The [EQUIPMENT] is not suitable for interconnection
Complies
with other equipment.
CISPR 14-1
RF emissions
The [EQUIPMENT] is not suitable for interconnection
13 Complies
with other equipment.
CISPR 15
– 16 – 60601-1-2 Amend. 1 CEI:2005
Page 42
Remplacer la Figure 201 existante par la suivante:
Début
pour les APPAREILS et SYSTÈMES
du CISPR 11
Remplacer "[APPAREIL ou SYSTÈME]" par la RÉFÉRENCE
DU MODÈLE ou DU TYPE de l'APPAREIL ou du SYSTÈME
Groupe 1
Supprimer les lignes 4,
Groupe 2
Supprimer les lignes 5,
Groupe?
12 et 13 du Tableau 201*
12 et 13 du Tableau 201*
B
A** Remplacer "[A ou B]"
Remplacer "[A ou B]"
Classe?
par "A"
par "B"
Conformité à
Conforme Non applicable
la CEI 61000-3-2 et à
la CEI 61000-3-3?
Remplacer "[Classe A, B, C, D, ou Non applicable]" Remplacer "[Classe A, B, C, D, ou Non applicable]"
en ligne 7, par la classe de la CEI 61000-3-2
en ligne 7, et "[Conforme ou Non applicable]"
et remplacer "[Conforme ou Non applicable]"
en ligne 8, par "Non applicable"*
en ligne 8, par "Conforme"*
Fusionner les cellules en
Fusionner les cellules en
colonne 3, lignes 6, 7 et 8*
colonne 3, lignes 6, 7 et 8*
Appareil professionnel
de type A prévu pour une Non
Oui
utilisation domestique ou sur
RESEAU ELECTRIQUE public
A**
justifiée?
Classe?
B
Déplacer le texte de la colonne 3, Déplacer le texte de la colonne 3,
Déplacer le texte de la colonne 3,
ligne 9, dans la cellule fusionnée* ligne 10, dans la cellule fusionnée* ligne 11, dans la cellule fusionnée*
Utilisation
Oui
Allocation du
Oui
spécifiée uniquement
36.201.1 a) 4)
en un emplacement
utilisée?
blindé ?
Ajouter le texte spécifié
par 6.8.3.201 c) 2)
Non
Non
Supprimer les lignes 9, 10 et 11*
Supprimer les numéros
* Les numéros de ligne se référent à ceux du Tableau 201
de ligne
avant que les modifications ne soient effectuées.
** Y compris les APPAREILS OU LES SYSTEMES
Fin PROFESSIONNELS DE TYPE A
IEC 1258/04
Figure 201 – Instructions servant à remplir le Tableau 201 pour les APPAREILS
et les SYSTEMES du CISPR 11 (voir 6.8.3.201 a) 3))
60601-1-2 Amend. 1 IEC:2005 – 17 –
Page 43
Replace the existing Figure 201 with the following:
Start
for CISPR 11 EQUIPMENT
and SYSTEMS
Replace "[EQUIPMENT or SYSTEM]" with the MODEL
of the EQUIPMENT or SYSTEM
OR TYPE REFERENCE
Group 2 Group 1
Delete rows 4, 12 and 13
Delete rows 5, 12 and 13
Group?
from Table 201* from Table 201*
A**
B
Replace "[A or B]"
Replace "[A or B]"
Class?
with "A"
with "B"
Complies Not applicable
IEC 61000-3-2 and
61000-3-3 compliance?
Replace "[Class A, B, C, D, or Not
Replace "[Class A, B, C, D, or Not applicable]"
applicable]" in row 7 with the IEC 61000-3-2
in row 7 and "[Complies or Not applicable]" in
class and replace "[Complies or Not
row 8 with "Not applicable"*
applicable]" in row 8 with "Complies"*
Merge cells in column
Merge cells in column
3 of rows 6, 7 and 8*
3 of rows 6, 7 and 8*
TYPE A PROFESSIONAL EQUIPMENT
No
or SYSTEM intended and justified
for domestic or PUBLIC MAINS
A**
Class?
use?
B
Yes
Move text from column 3 Move text from column 3 Move text from column 3
of row 10 into merged cell*
of row 9 into merged cell* of row 11 into merged cell*
Specified for use Yes Allowance in
Yes
only in a shielded
36.201.1 a) 4) used?
location?
Add text specified
by 6.8.3.201 c) 2)
No
No
Delete rows 9, 10 and 11*
Delete row numbers * Row numbers refer to those in Table 201
before modifications are made.
** Including TYPE A PROFESSIONAL
End
EQUIPMENT and SYSTEMS
IEC 1258/04
Figure 201 – Instructions for completing Table 201
for CISPR 11 EQUIPMENT and SYSTEMS
(see 6.8.3.201 a) 3))
– 18 – 60601-1-2 Amend. 1 CEI:2005
Page 44
Remplacer la Figure 202 existante par la suivante:
Début
Début
pour les APPAREILS
pour les APPAREILS
du CISPR 15
du CISPR 14
Remplacer "[APPAREIL]" par la Remplacer "[APPAREIL]" par la
RÉFÉRENCE DU MODÈLE ou
RÉFÉRENCE DU MODÈLE ou
DU TYPE de l'APPAREIL
DU TYPE de l'APPAREIL
Supprimer les lignes 4 à 6 et Supprimer les lignes 4 à 6 et
la ligne 13 du Tableau 201*
la ligne 12 du Tableau 201*
Conformité à
Conforme Non applicable
la CEI 61000-3-2 et à
la CEI 61000-3-3?
Remplacer "[Classe A, B, C, D, ou Non applicable]"
Remplacer "[Classe A, B, C, D, ou Non applicable]"
en ligne 7 par la classe de la CEI 61000-3-2, et
en ligne 7, et "[Conforme ou Non applicable]"
remplacer "[Conforme ou Non applicable]"
en ligne 8, par "Non applicable"*
en ligne 8, par "Conforme"*
Fusionner les cellules en
Fusionner les cellules en
colonne 3, lignes 7 et 8* colonne 3, lignes 7 et 8*
Déplacer le texte de la colonne 3,
Déplacer le texte de la colonne 3,
ligne 9, dans la cellule fusionnée*
ligne 10, dans la cellule fusionnée*
Supprimer les lignes 9, 10 et 11*
Supprimer les numéros de ligne
* Les numéros de ligne se référent à ceux
Fin
du Tableau 201 avant que les modifications
ne soient effectuées.
IEC 1259/04
Figure 202 – Instructions servant à remplir le Tableau 201 pour les APPAREILS
des CISPR 14 et CISPR 15 (voir 6.8.3.201 a) 3))
60601-1-2 Amend. 1 IEC:2005 – 19 –
Page 45
Replace the existing Figure 202 with the following:
Start
Start
for CISPR 15
for CISPR 14
EQUIPMENT
EQUIPMENT
Replace "[EQUIPMENT]" with the
Replace "[EQUIPMENT]" with the
MODEL OR TYPE REFERENCE of MODEL OR TYPE REFERENCE of the
EQUIPMENT EQUIPMENT
the
Delete rows 4 through 6 and
Delete rows 4 through 6 and
row 13 from Table 201*
row 12 from Table 201*
Complies Not applicable
IEC 61000-3-2 and
61000-3-3
compliance?
Replace "[Class A, B, C, D, or Not
Replace "[Class A, B, C, D, or Not applicable]"
applicable]" in row 7 with the IEC 61000-3-2
in row 7 and "[Complies or Not applicable]" in
class and replace "[Complies or Not
row 8 with "Not applicable"*
applicable]" in row 8 with "Complies"*
Merge cells in column 3 Merge cells in column 3
of rows 7 and 8* of rows 7 and 8*
Move text from column 3 of
Move text from column 3 of
row 9 into merged cell* row 10 into merged cell*
Delete rows 9, 10 and 11*
Delete row numbers
* Row numbers refer to those in Table 201
End
before modifications are made.
IEC 1259/04
Figure 202 – Instructions for completing Table 201
for CISPR 14 and CISPR 15 EQUIPMENT
(see 6.8.3.201 a) 3))
– 20 – 60601-1-2 Amend. 1 CEI:2005
Page 46
Dans le Tableau 202, remplacer "mode différentiel" par " entre lignes" et " mode commun" par
" entre ligne et terre"
Page 66
36 COMPATIBILITE ELECTROMAGNETIQUE
36.201 Émissions
36.201.1 Protection des services radio
*a) Exigences
Remplacer à la dernière ligne du premier alinéa existant de ce paragraphe, "4) et 5)" par "
4), 5) et 6)".
Page 68
Renuméroter le point a) 6) existant en a) 7) et insérer le nouveau point a) 6) suivant dans ce
paragraphe:
*6) APPAREILS et SYSTEMES PROFESSIONNELS de TYPE A
Les APPAREILS et SYSTEMES PROFESSIONNELS du Groupe 2 du CISPR 11 qui sont prévus
pour être utilisés dans des locaux domestiques ou raccordés au RESEAU ELECTRIQUE PUBLIC
doivent être conformes aux exigences de la classe B du CISPR 11 Groupe 2, à l'exception
du troisième harmonique de la fréquence fondamentale de l'APPAREIL ou du SYSTEME qui peut
respecter les limites pour les perturbations électromagnétiques rayonnées de la classe A du
CISPR 11 Groupe 2, à condition que cela soit justifié par:
– des limitations physiques, technologiques ou physiologiques significatives qui
empêchent la conformité des limites pour les perturbations électromagnétiques rayonnées
de la classe B du CISPR 11 Groupe 2 pour le troisième harmonique de la fréquence
fondamentale de l'APPAREIL ou du SYSTEME et
– le besoin d'utiliser l'APPAREIL ou le SYSTEME dans des locaux domestiques ou raccordé
au RESEAU ELECTRIQUE PUBLIC.
(Voir 6.8.2.201 d) et 6.8.3.201 j)).
b) Essais
Remplacer dans le premier paragraphe, "1) et 2) ci-dessous" par " 1), 2) et 3) ci-dessous".
Remplacer dans la note 10 de bas de page, "CISPR 11:1997" par " CISPR 11:2003".
60601-1-2 Amend. 1 IEC:2005 – 21 –
Page 47
In Table 202, replace “differential mode” with “line(s) to line(s)” and “common mode” with
“line(s) to earth”.
Page 67
36 ELECTROMAGNETIC COMPATIBILITY
36.201 Emissions
36.201.1 Protection of radio services
*a) Requirements
Replace, in the last line of the first paragraph of this item, “4) and 5)” with “4), 5) and 6)”.
Page 69
Renumber the existing item a) 6) as a) 7) and insert the following new item a) 6) in this
subclause:
*6) TYPE A PROFESSIONAL EQUIPMENT and SYSTEMS
CISPR 11 Group 2 PROFESSIONAL EQUIPMENT and SYSTEMS that are intended for use in
domestic establishments or connection to the PUBLIC MAINS NETWORK shall comply with
CISPR 11 Group 2 Class B, with the exception that the third harmonic of the fundamental
frequency of the EQUIPMENT or SYSTEM may comply with the CISPR 11 Group 2 Class A
electromagnetic radiation disturbance limit, provided this is justified based on:
– significant physical, technological or physiological limitations that prevent compliance
with the CISPR 11 Group 2 Class B electromagnetic radiation disturbance limit at the
third harmonic of the fundamental frequency of the EQUIPMENT or SYSTEM and
– the need for the use of the EQUIPMENT or SYSTEM in domestic establishments or
connected to the PUBLIC MAINS NETWORK.
(See 6.8.2.201 d) and 6.8.3.201 j).)
b) Tests
Replace, in the first paragraph, “1) and 2) below” with “1), 2) and 3) below”.
Replace, in Footnote 10, “CISPR 11:1997” with “CISPR 11: 2003”.
– 22 – 60601-1-2 Amend. 1 CEI:2005
Page 72
36.202 IMMUNITE
36.202.1 Généralités
Remplacer le point d) existant par ce qui suit:
*d) Appareils non électromédicaux
Un appareil non électromédical fourni en tant qu'élément d'un SYSTEME est dispensé des
exigences d'essais d'IMMUNITE de cette norme, si toutes les conditions suivantes sont
satisfaites (voir également l'Annexe HHH):
– l'appareil non électromédical est conforme aux normes internationales d'IMMUNITE
applicables ;
– les EMISSIONS et l'IMMUNITE de l'appareil non électromédical utilisé dans un SYSTEME
ont été déterminées comme ne compromettant pas les performances essentielles ou la
sécurité du SYSTEME.
Remplacer, à la page 74, le point h) par ce qui suit:
*h) Essais des FONCTIONS normalement non observables
Si une FONCTION associée à une performance essentielle (par exemple cONDITION
D'ALARME DE PRIORITE ELEVEE et CONDITION D'ALARME DE PRIORITE MOYENNE) ne peut
normalement être observée ou vérifiée pendant l'essai, une méthode doit être fournie (par
exemple affichage des paramètres internes) afin de déterminer la conformité.
L'utilisation de programme ou de matériel spécial peut être nécessaire.
Remplacer, à la page 76, les neuvième et dixième paragraphes du point j) par ce qui suit:
– bruit sur une forme d'onde qui pourrait interférer avec le diagnostic, le traitement ou la
surveillance;
– artéfact
...
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