IEC 60601-1-2:2001/AMD1:2004

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
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– 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• withdrawn,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 opera
...