SIST EN 60601-1-2:2002/A1:2006
(Amendment)Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
D129/100: To be offered to EC for publication in the OJEC under the MDD
Medizinische elektrische Geräte -- Teil 1-2: Allgemeine Festlegungen für die Sicherheit - Ergänzungsnorm: Elektromagnetische Verträglichkeit - Anforderungen und Prüfungen
Appareils électromédicaux -- Partie 1-2: Règles générales de sécurité - Norme collatérale: Compatibilité électromagnétique - Exigences et essais
Medicinska električna oprema – 1-2. del: Splošne varnostne zahteve – Spremljevalni standard: Elektromagnetna združljivost – Zahteve in preskusi (IEC 60601-1-2:2001/A1:2004)
General Information
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Standards Content (Sample)
EUROPEAN STANDARD
EN 60601-1-2/A1
NORME EUROPÉENNE
May 2006
EUROPÄISCHE NORM
ICS 11.040.01; 33.100.10; 33.100.20
English version
Medical electrical equipment
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility -
Requirements and tests
(IEC 60601-1-2:2001/A1:2004)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 1-2: Règles générales de sécurité - Teil 1-2: Allgemeine Festlegungen
Norme collatérale: für die Sicherheit -
Compatibilité électromagnétique - Ergänzungsnorm:
Exigences et essais Elektromagnetische Verträglichkeit -
(CEI 60601-1-2:2001/A1:2004) Anforderungen und Prüfungen
(IEC 60601-1-2:2001/A1:2004)
This amendment A1 modifies the European Standard EN 60601-1-2:2001; it was approved by CENELEC on
2006-03-01. 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 Central Secretariat 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
Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-2:2001/A1:2006 E
---------------------- Page: 1 ----------------------
EN 60601-1-2:2001/A1:2006 - 2 -
Foreword
The text of document 62A/462/FDIS, future amendment 1 to IEC 60601-1-2:2001, prepared by
IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote
and was approved by CENELEC as amendment A1 to EN 60601-1-2:2001 on 2006-03-01.
The following dates were fixed:
– latest date by which the amendment has to be
implemented at national level by publication of
(dop) 2006-12-01
an identical national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2009-03-01
with the amendment have to be withdrawn
__________
Endorsement notice
The text of amendment 1:2004 to the International Standard IEC 60601-1-2:2001 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
---------------------- Page: 2 ----------------------
NORME CEI
INTERNATIONALE
IEC
60601-1-2
INTERNATIONAL
2001
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
---------------------- Page: 3 ----------------------
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.
---------------------- Page: 4 ----------------------
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).
---------------------- Page: 5 ----------------------
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:
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: 6 ----------------------
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
———————
1
See Annex BBB for examples. These modifications should be performed in the order in which they appear.
2
Row numbers refer to those in Table 201 before modifications are made.
---------------------- Page: 7 ----------------------
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.
---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
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
1
Guidance and manufacturer’s declaration – electromagnetic emissions
The [EQUIPMENT or SYSTEM] is intended for use in the electromagnetic environment specified below. The
2
customer or the user of the [EQUIPMENT or SYSTEM] should assure that it is used in such an environment.
3
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
4
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
5
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,
7
or Not applicable]
IEC 61000-3-2
Voltage fluctuations/
[Complies or Not
flicker emissions
8
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:
10
[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)
11
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
12
Complies
with other equipment.
CISPR 14-1
RF emissions
The [EQUIPMENT] is not suitable for interconnection
13 Complies
with other equipment.
CISPR 15
---------------------- Page: 10 ----------------------
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
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))
---------------------- Page: 11 ----------------------
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))
---------------------- Page: 12 ----------------------
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”.
---------------------- Page: 13 ----------------------
60601-1-2 Amend. 1 IEC:2005 – 23 –
Page 73
36.202 IMMUNITY
36.202.1 General
Replace, on page 73, 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):
– the non-medical electrical equipment complies with applicable international IMMUNITY
3
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 75, 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 77, 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 79
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 83, 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.
———————
3
For example see CISPR 24 for ITE and IEC 61326-1 for measurement, control and laboratory equipment.
---------------------- Page: 14 ----------------------
60601-1-2 Amend. 1 IEC:2005 – 25 –
Page 89
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”.
Page 91
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 97, 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 104
Annex AAA – General guidance and rationale
Subclause 2.212
Add, on page 106, 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 108, 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.
---------------------- Page: 15 ----------------------
60601-1-2 Amend. 1 IEC:2005 – 27 –
Add, on page 109, 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 directly
operated by a healthcare professional. In contrast, “under medical supervision” includes all
EQUIPMENT and SYSTEMS prescribed by a healthcare professional, even if operated by the
patient or another caregiver when a healthcare professional is not present.
The definition of “PROFESSIONAL EQUIPMENT or SYSTEM” is included in this amendment to prevent
the use of the allowance specified in 36.201.1 a) 6) for over-the-counter medical equipment
after the third edition of IEC 60601-1 is published.
Delete the heading “Subclause 3.201.2” and the rationale.
Delete the heading “Subclause 3.201.4” and the rationale.
Add the following new subclause:
Subclause 3.201.5
Certain SINGLE FAULT CONDITIONS would have a significant adverse effect on EMC performance
of an EQUIPMENT or SYSTEM. Some EMC techniques redirect DISTURBANCES to ground or
dissipate them in circuit components. If the PROTECTIVE EARTH CONDUCTOR is interrupted or
failure of a component in an ELECTROMAGNETIC DISTURBANCE filter is simulated during EMC
testing, it could be very difficult to meet the EMC requirements of this standard. Therefore,
EMC testing is specified to be performed under NORMAL CONDITIONS and not SINGLE FAULT
CONDITIONS.
If ELECTROMAGNETIC DISTURBANCES specified as IMMUNITY TEST LEVELS in this standard were
considered to be SINGLE FAULT CONDITIONS, then 3.201.5 could be interpreted to mean that
IMMUNITY testing of EQUIPMENT and SYSTEMS should not be performed. Because they ar
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