IEC 60601-2-22:2007

INTERNATIONAL IEC
STANDARD
CEI
60601-2-22
NORME
Third edition
INTERNATIONALE
Troisième édition
2007-05
Medical electrical equipment –
Part 2-22:
Particular requirements for basic safety and
essential performance of surgical, cosmetic,
therapeutic and diagnostic laser equipment

Appareils électromédicaux –
Partie 2-22:
Règles particulières pour la sécurité de base
et les performances essentielles des appareils
chirurgicaux, esthétiques, thérapeutiques et de
diagnostic à laser
Reference number
Numéro de référence
IEC/CEI 60601-2-22:2007
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INTERNATIONAL IEC
STANDARD
CEI
60601-2-22
NORME
Third edition
INTERNATIONALE
Troisième édition
2007-05
Medical electrical equipment –
Part 2-22:
Particular requirements for basic safety and
essential performance of surgical, cosmetic,
therapeutic and diagnostic laser equipment

Appareils électromédicaux –
Partie 2-22:
Règles particulières pour la sécurité de base
et les performances essentielles des appareils
chirurgicaux, esthétiques, thérapeutiques et de
diagnostic à laser
PRICE CODE
U
CODE PRIX
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue
Pour prix, voir catalogue en vigueur

– 2 – 60601-2-22 © IEC:2007
CONTENTS
FOREWORD.3

INTRODUCTION.5

201.1 Scope, object and related standards.6

201.2 Normative references .8

201.3 Terms and definitions .8

201.4 General requirements.10

201.5 General requirements for testing ME EQUIPMENT.10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .10
201.7 ME EQUIPMENT identification, marking and documents.10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT .12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.13
201.10 Protection against unwanted and excessive radiation HAZARDS.13
201.11 Protection against excessive temperatures and other HAZARDS.15
201.12 Accuracy of controls and instruments and protection against hazardous outputs .15
201.13 HAZARDOUS SITUATIONS and fault conditions .16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .18
201.15 Construction of ME EQUIPMENT .18
201.16 ME SYSTEMS.18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.19

Annexes .19
Annex D (informative) Symbols on marking.19
Annex AA (informative) Particular guidance and rationale.22

Bibliography.24
Index of defined terms used in this particular standard.25

Table D.1 – General symbols.19

60601-2-22 © IEC:2007 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION

________________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-22: Particular requirements for basic safety and essential

performance of surgical, cosmetic, therapeutic

and diagnostic laser equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
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with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-22 has been prepared by IEC subcommittee 76: Optical
radiation safety and laser equipment.
This third edition cancels and replaces the second edition of IEC 60601-2-22, published in
1995. This edition constitutes a technical revision.
This third edition takes account of the recently published new editions of the General
Standard IEC 60601-1 and Group safety publication IEC 60825-1. Additionally, it addresses
technical and safety issues which have arisen in the time following the previous second
edition.
– 4 – 60601-2-22 © IEC:2007
The text of this particular standard is based on the following documents:

FDIS Report on voting
76/359/FDIS 76/363/RVD
Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA
The committee has decided that the contents of this 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.
60601-2-22 © IEC:2007 – 5 –
INTRODUCTION
This particular standard amends and supplements IEC 60601-1 (third edition, 2005: Medical

Electrical Equipment – Part 1: General requirements for basic safety and essential

performance).
This standard also refers to IEC 60825-1 (2007).

The requirements of this standard are the minimum that need to be complied with, in order to

achieve a reasonable level of safety and reliability during operation and application of medical

laser equipment.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA. Understanding
of the reasons for these requirements will not only facilitate the proper application of the
standard but will, in due course, expedite any revisions necessitated by changes in clinical
practice or by developments in technology.

– 6 – 60601-2-22 © IEC:2007
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-22: Particular requirements for basic safety and essential

performance of surgical, cosmetic, therapeutic

and diagnostic laser equipment

201.1 Scope, object and related standards

Clause 1 of the General Standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser
equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary
applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4
LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER
EQUIPMENT.
Throughout this International Standard, light emitting diodes (LED) are included whenever the
word “laser” is used.
NOTE 1 Refer to Definition 3.49 in IEC 60825-1.
NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are
covered by IEC 60825-1 and IEC 60601-1.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the General Standard.
NOTE See also 4.2 of the General Standard.
This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser
equipment used for compensation or alleviation of disease, injury or disability.

201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for the safety of surgical, cosmetic, therapeutic and diagnostic
laser equipment.
NOTE Laser classification (IEC 60825-1) must not be confused with electrical classification (IEC 60601-1).

60601-2-22 © IEC:2007 – 7 –
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the General Standard and Clause 2 of this particular standard.

IEC 60601-1-3 does not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in this standard as appropriate for the particular ME EQUIPMENT under consideration,
and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the General Standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the General Standard.
Collateral standards are referred to by their document number.
The numbering of sections, clauses and subclauses of this particular standard corresponds to
that of the General Standard or applicable collateral standard. The changes to the text of the
General Standard are specified by the use of the following words:
"Replacement" means that the clause or subclause of the General Standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the General Standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the General Standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa),
bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered
starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the General Standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the
section, clause or subclause of the General Standard or applicable collateral standard,
although possibly not relevant, applies without modification; where it is intended that any part
of the General Standard or applicable collateral standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this particular standard.

– 8 – 60601-2-22 © IEC:2007
Concerning LASER RADIATION safety of laser equipment, IEC 60825-1 applies, except that the

relevant requirements are specified, changed or amended in this particular standard.

Clauses and subclauses of the General Standard and IEC 60825-1, which are not applicable

to laser equipment for medical applications, are not necessarily indicated as "not applicable".

201.2 Normative references
Clause 2 of the General Standard applies, except as follows:

Addition:
IEC 60825-1:2007, Safety of laser products – Part 1: Equipment classification and
requirements
IEC 60947-3, Low-voltage switchgear and controlgear – Part 3: Switches, disconnectors,
switch-disconnectors and fuse-combination units
IEC 61010-1, Safety requirements for electrical equipment for measurement, control and
laboratory use – Part 1: General requirements
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
apply, except as follows:
Addition:
201.3.101
ACCESSIBLE EMISSION LIMIT (AEL)
ACCESSIBLE EMISSION LIMIT for CLASS 1M, 2, 2M, 3R, or 3B lasers (see 3.3 and Tables 4
through 9 of IEC 60825-1)
201.3.102
AIMING BEAM
beam of optical radiation, producing a visible AIMING BEAM SPOT, intended for indication of the
anticipated point of impact of the WORKING BEAM
201.3.103
AIMING BEAM SPOT
area of impact of the AIMING BEAM within the WORKING AREA
201.3.104
AIMING LASER
LASER emitting an AIMING BEAM
201.3.105
APERTURE
distal opening of the BEAM DELIVERY SYSTEM (see 3.8 of IEC 60825-1)

60601-2-22 © IEC:2007 – 9 –
201.3.106
BEAM DELIVERY SYSTEM
optical system which guides the LASER RADIATION from its origin to the WORKING AREA

201.3.107
CLASS 1, 1M, 2, 2M, 3R, 3B, OR 4 LASER PRODUCT

laser equipment, incorporating a LASER as defined in 3.41 and 3.18 through 3.23 of

IEC 60825-1
201.3.108
EMERGENCY LASER STOP
hand- or foot-actuated device intended to stop the LASER OUTPUT immediately in case of
emergency
201.3.109
LASER EMISSION CONTROL SWITCH
hand- or foot-actuated device intended to initiate and stop WORKING BEAM emission through
any APERTURE
201.3.110
LASER EMISSION INDICATOR
visible and/or audible signal which indicates that the WORKING BEAM is being emitted through
any APERTURE
NOTE The LASER EMISSION INDICATOR is different from the LASER RADIATION EMISSION warning requirement 4.7 of
IEC 60825-1.
201.3.111
LASER ENERGY
RADIANT ENERGY of the WORKING BEAM, incident on the WORKING AREA (see 3.70 of
IEC 60825-1)
201.3.112
LASER OPERATOR
the person who handles the laser equipment. In general, the LASER OPERATOR controls the
delivery of the laser radiation to the WORKING AREA. The LASER OPERATOR may appoint other
person(s), who assist with the selection and/or setting of the parameters
Refer to Definition 3.73 in IEC 60601-1.
NOTE The safety requirements in this standard apply to all above persons.
201.3.113
LASER OUTPUT
either LASER POWER or LASER ENERGY
201.3.114
LASER POWER
RADIANT POWER of the WORKING BEAM, incident on the WORKING AREA, see 3.72 of IEC 60825-1
201.3.115
LASER READY INDICATOR
visible means which indicate that the laser equipment is in the READY condition, and the
purpose of which is to make all persons present in the laser area aware of the need to take
precautions against hazardous LASER RADIATION, as detailed in the ACCOMPANYING DOCUMENTS
(instructions for use). See 201.7.9.

– 10 – 60601-2-22 © IEC:2007
201.3.116
OPERATOR PROTECTIVE FILTER
a moveable or fixed filter which does not allow radiation in excess of the MAXIMUM PERMISSIBLE

EXPOSURE (MPE) to the LASER OPERATOR

NOTE For the definition of MPE, see 3.56 of IEC 60825-1.

201.3.117
SHUTTER
electronic, opto-electronic and/or mechanical means which allows or prevents LASER OUTPUT

to be emitted from the APERTURE

201.3.118
STAND-BY/READY
modes of operation when mains supply is connected and the mains switch activated, where
the STAND-BY mode means that the laser is not capable of emitting the WORKING BEAM even if
the laser control switch is activated, and where the READY mode keeps the laser equipment
enabled, so that it is capable of emitting LASER OUTPUT when the control switch is activated
201.3.119
TARGET INDICATING DEVICE
an aiming device which designates the position where the WORKING BEAM will perform its
surgical, cosmetic, therapeutic or diagnostic purpose
201.3.120
WORKING AREA
area which is intended to be irradiated with WORKING BEAM
201.3.121
WORKING BEAM
beam of LASER RADIATION emitted by the laser equipment for surgical, cosmetic, therapeutic or
diagnostic purposes (other than the AIMING BEAM)
201.4 General requirements
Clause 4 of the General Standard applies.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the General Standard applies.

201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the General Standard applies.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the General Standard applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Addition:
60601-2-22 © IEC:2007 – 11 –
201.7.2.101 Additional items
See Clause 5 of IEC 60825-1.
a) General
Laser equipment shall carry labels in accordance with 5.5, 5.6, 5.8, 5.9, 5.10, 5.11 of

IEC 60825-1, as applicable.
b)* Aperture label
Laser equipment shall have a label positioned as close as practicable to each laser

aperture. The label shall be similar to the laser hazard symbol as specified in

IEC 60825-1, Figure 1, with the exception that the size can be adjusted as appropriate
or alternatively be similar to the label described in 5.7 of IEC 60825-1. Hand-pieces and
other applicators are exempt from these requirements. In this case, a label is to be
affixed in a prominent position with either:
– a statement that the laser aperture is on the end of the fibre/applicator, or
– a symbol as detailed in Table D.1, number 113.
NOTE The required information can be combined into one single label if the area where the label is to be affixed
is suitable.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall give adequate instructions for proper operation,
including clear warnings concerning precautions to avoid possible exposure to hazardous
LASER RADIATION.
201.7.9.2 Instructions for use
201.7.9.2.13 Maintenance
Addition:
The instructions for maintenance shall include clear warnings concerning precautions to avoid
possible exposure to hazardous laser radiation.
201.7.9.2.101 Laser specific information for the responsible organization and for the
LASER OPERATOR
The instructions for use shall include (as applicable):
– information on the NOMINAL OCULAR HAZARD DISTANCE (NOHD) for the laser equipment in
NORMAL USE with each appropriate ACCESSORY;
– a statement in SI units of BEAM DIVERGENCE, PULSE DURATION, maximum LASER OUTPUT of
the LASER RADIATION, with the magnitudes of the cumulative measurement uncertainty and
any expected increase in the measured quantities at any time after manufacture added to
the values measured at the time of manufacture;
– legible reproductions (colour optional) of all required LASER labels and hazard warnings
affixed to the laser equipment;

– 12 – 60601-2-22 © IEC:2007
– information and guidance for regular calibration of the LASER OUTPUT in accordance with

201.12.1 of this standard. The information shall include a specification for the measuring

equipment and frequency of calibration and clarification requirements concerning regular

calibration of LASER OUTPUT;
– a clear indication of all locations of laser APERTURES;

– a listing of controls, adjustments and procedures for operation and maintenance by the

RESPONSIBLE ORGANISATION, including the warning "Caution – Use of controls or

adjustments or performance of procedures other than those specified herein may result in

hazardous radiation exposure";

– a description of the BEAM DELIVERY SYSTEMS including the characteristics of the LASER
OUTPUT;
– A note, saying that laser equipment should be protected against unauthorized use, for
example by removal of the key from the key switch;
– a specification for eye protection;
NOTE Refer to 8.4.5.2 of IEC/TR 60825-14 (2004), Safety of laser products – Part 14: A user’s guide.
– a specification for fume and plume extraction, including a cautionary statement: "Caution –
Laser fume and/or plume may contain viable tissue particulates";
– information about the potential hazards when inserting, sharply bending or improperly
securing the fibre optics, stating that not following the recommendations of the
manufacturer may lead to damage to the fibre or delivery system and/or harm to the
patient or LASER OPERATOR;
– recommendation, for example as follows: "As the AIMING BEAM passes down the same
WORKING BEAM, it provides a good means of checking the integrity
delivery system as the
of the delivery system. If the AIMING BEAM is not present at the distal end of the delivery
system, its intensity is reduced or it looks diffused, this is a possible indication of a
damaged or malfunctioning delivery system";
LASER
– a warning, for example as follows: “A risk of fire and/or explosion exists when the
OUTPUT is used in the presence of flammable materials, solutions or gases, or in an
oxygen enriched environment”. The high temperatures produced in NORMAL USE of the
laser equipment may ignite some materials, for example cotton wool when saturated with
oxygen. The solvents of adhesives and flammable solutions used for cleaning and
disinfecting should be allowed to evaporate before the laser equipment is used. Attention
should also be drawn to the danger of ignition of endogenous gases.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the General Standard applies except as follows:
201.8.5 Separation of parts
Amendment:
If an OEM (Original Equipment Manufacturer) laser and/or OEM laser power supply is
incorporated into the laser product and the OEM product complies with IEC 61010-1, then the
OEM product is exempt from the differing requirements of IEC 60601-1. This exemption
applies to the means of operator protection (MOOP) and to the requirements of
Subclauses 8.6, 8.8, and 8.9.
EAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7 L
This subclause of the General Standard applies except as follows:

60601-2-22 © IEC:2007 – 13 –
201.8.7.3 * Allowable values
Addition:
Laser equipment is considered as PERMANENTLY INSTALLED equipment if:

– it is connected to the SUPPLY MAINS by means of a MAINS PLUG which is mechanically

secured against unintentional loosening,

– the POWER SUPPLY CORD is non-detachable, and

– the cross-sectional area of the POWER SUPPLY CORD conductors are not less than
2,5 mm Cu.
201.8.10 Components and wiring
This subclause of the General Standard applies except as follows:
201.8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated control
devices
Addition:
201.8.10.4.101 Footswitch
Any foot-operated laser emission control switch shall be shrouded to prevent unintentional
operation. The force required to actuate the switch shall be not less than 10 N, applied over
an area of 625 mm anywhere on the operating surface of the footswitch. This force shall not
exceed 50 N.
Compliance is checked by measurement of the actuating force.
201.8.11 MAINS PARTS, components and layout
Addition:
201.8.11.101 Use of water for cooling
Where water is used in electrical CLASS I EQUIPMENT for cooling and where the water assumes
EARTH
the role of basic insulation to mains, the conductivity of the water shall be such that the
LEAKAGE CURRENT values required in 201.8.7.3 are not exceeded in NORMAL USE. The
manufacturer shall specify periodic maintenance information and methods of measurement.
Compliance is checked by inspection and measurement.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the General Standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the General Standard applies, except as follows:
201.10.4 Lasers and light emitting diodes (LEDs)
Addition:
– 14 – 60601-2-22 © IEC:2007
NOTE In the context of this standard, "light" radiation is understood to cover optical radiation as specified in

IEC 60825-1.
For the protection of the PATIENT, the LASER OPERATOR and other persons present, the laser

equipment shall comply with the following requirements:

a) REMOTE INTERLOCK CONNECTOR (4.4 of IEC 60825-1)

This requirement does not apply to battery-powered hand-held medical laser equipment.

b) Key control (4.6 of IEC 60825-1)

c) Viewing optics (4.10 of IEC 60825-1)

Additionally, the laser equipment shall incorporate:
d) Laser ready indicator
Laser equipment shall incorporate a visible LASER READY INDICATOR, which shall be
illuminated when emission of the WORKING BEAM is possible upon actuation of the control
switch, to allow appropriate safety precautions to be taken.
e) Laser emission indicators
In addition to the LASER READY INDICATOR, laser equipment shall be equipped with a visible
and an audible signal, which clearly indicate that emission of LASER RADIATION in excess of
the AEL for CLASS 3R is taking place. The LASER EMISSION INDICATORS shall be designed as
described in 4.7 of IEC 60825-1.
Both, the LASER READY INDICATOR and the visible LASER EMISSION INDICATOR shall be visible
through laser protective eyewear worn by those present in the laser area.
Provided that one of the LASER EMISSION INDICATORS is clearly visible or audible to the
persons in the vicinity of the operational control or laser APERTURE, the 2 m distance
requirement of Subclause 4.7.3 of IEC 60825-1 is not applicable.
NOTE 1   Since this standard requires a LASER READY INDICATOR and two LASER EMISSION INDICATORS, the FAIL
SAFE or redundancy requirement in Subclause 4.7.2 of IEC 60825-1 is not applicable.
NOTE 2   AIMING BEAMS are not considered to be indicator lights.
f) *TARGET INDICATING DEVICE (see 201.15.101)
If the TARGET INDICATING DEVICE is in the form of an AIMING BEAM which is emitted from the
laser APERTURE and is generated by an AIMING LASER, or is an attenuated WORKING BEAM, it
shall not exceed the AEL for CLASS 3R with the following exception:
For an ophthalmic AIMING LASER, the AIMING BEAM shall not exceed the AEL for CLASS 2
without a deliberate and positive action by the LASER OPERATOR.
g) STAND-BY/READY control
Laser equipment shall be equipped with a STAND-BY/READY device. This device shall be
capable of disabling the WORKING BEAM.

Transition from STAND-BY to READY shall not be possible when the LASER EMISSION CONTROL
SWITCH is activated.
h) ENCLOSURES
The following requirements of IEC 60825-1 apply:
– 4.2.1 Protective housing – general;
– 4.2.2 Protective housing – service;
– 4.3 Access panels and safety interlocks.
Compliance is checked by inspection.
NOTE The beam stop according to 4.8 of IEC 60825-1 is replaced by the requirement for a STAND-BY/READY
device.
60601-2-22 © IEC:2007 – 15 –
201.11 Protection against excessive temperatures and other HAZARDS

Clause 11 of the General Standard applies, except as follows:

201.11.8 Interruption of the power supply /supply mains to ME EQUIPMENT

Addition:
201.11.8.101 Interruption of emission

CLASS 4 laser equipment shall be provided with a manual reset to enable resumption of LASER

RADIATION emission after interruption of emission e.g. caused by the use of a remote interlock
or caused by the unexpected loss of SUPPLY MAINS.
NOTE This manual reset could be removal of the foot from the footswitch and placing it back on again.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the General Standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Addition:
201.12.1.101 Indication of LASER OUTPUT
Laser equipment shall incorporate a means for the indication of the preset level of the output
of the WORKING BEAM.
The indication shall be in SI units.
The actual LASER OUTPUT measured in the WORKING AREA shall not deviate from the set value
by more than ±20 %. Where the laser equipment is calibrated in watts and incorporates a
timer-controlled exposure system, the LASER ENERGY shall not deviate by more than ±20 %.
This subclause does not apply if the LASER OUTPUT is fixed by the manufacturer and is not
adjustable. In this case, the fixed LASER OUTPUT shall be stated by labelling.
Compliance is checked by inspection and measurements.

201.12.4 Protection against hazardous output
This subclause of the General Standard applies, except as follows:
201.12.4.2 Indication of parameters relevant to safety
Addition:
The indicated LASER OUTPUT emitted by the laser equipment shall not deviate from the preset
value by more than ±20 %. A measured quantity, electrical or optical, which is directly related
to the LASER OUTPUT generated, shall be monitored during operation. The monitoring shall be
carried out at intervals shorter than the failure tolerance time (see Annex AA, rationale to
201.12.4.4).
– 16 – 60601-2-22 © IEC:2007
Typical solutions are:
– closed-loop system;
– open-loop system with a visible and/or audible out-of-tolerance warning.

Compliance test: during use under NORMAL CONDITIONS, as well as under any reasonably

foreseeable SINGLE FAULT CONDITION, the LASER OUTPUT is checked to be within the allowed

tolerance or the required warning is given otherwise.

The calibration of the system is to be checked at regular intervals against the LASER POWER

(or LASER ENERGY) actually emitted on the WORKING AREA. An appropriate method shall be
th
described in the instructions for use in accordance with 201.7.9.2.101, 4 dash.
201.12.4.4* Incorrect output
See Annex AA, rationale for Subclause 201.12.4.4.
Addition:
201.12.4.4.101 Emergency laser stop
The EMERGENCY LASER STOP shall stop the emission of LASER OUTPUT as fast as possible to
prevent a situation where there is an unacceptable risk to any person. The EMERGENCY LASER
STOP shall be designed so as to be independent of all other LASER stop systems. The switch
shall be a red push-button and be located in such a manner as to be readily visible and easily
and quickly reached by the LASER OPERATOR from the operating position. "Laser Stop" or the
symbol according to Table D.1, symbol 101, shall be marked on or near the push-button.
If an emergency stop according to IEC 60947-3 is incorporated in the laser equipment, the
EMERGENCY LASER STOP is not required.
Exempt from this requirement are CLASS 3B LASERS for non-surgical or non-ophthalmic use
within the wavelength range of 600 nm to 1 400 nm,
a) emitting less than five times the MPE for the skin and not more than 50 mW average
power, or
b) not exceeding the MPE for the skin.
Compliance is checked by inspection and measurements.
201.13 HAZARDOUS SITUATIONS and fault conditions

Clause 13 of the General Standard applies, except as follows:
201.13.1 Specific hazardous situations
Addition:
201.13.1.101 Specific laser considerations
The following hazardous situations shall be taken into consideration:
a) emission of LASER POWER of more than twice the set value for a time period exceeding
100 ms;
60601-2-22 © IEC:2007 – 17 –
b) emission of pulsed LASER ENERGY, if the preceding pulse of LASER ENERGY exceeded twice

the set value.
c) emission of repeatedly pulsed LASER ENERGY, if consecutive pulses of LASER ENERGY

exceed twice the set value and the time period of consecutive emissions exceeds 100 ms.

d) faulty release of the WORKING BEAM.

e) failure of the cut-off of the WORKING BEAM.

Exempt from the requirements a), b) and c) are CLASS 3B LASERS for non-surgical or non-
ophthalmic use within the wavelength range of 600 nm to 1 400 nm,

– emitting less than five times the MPE for the skin and not more than 50 mW average

power, if by design this power cannot be exceeded, or
– not exceeding the MPE for the skin.
201.13.2 SINGLE FAULT CONDITIONS
Addition:
201.13.2.101 Excessive LASER OUTPUT
CLASS 3B or 4 lasers shall be so designed that a single fault condition of any form does not
result in an increase in accessible output greater than 50 % beyond nominal (see note), or in
an unintended emission of laser radiation. An out-of-tolerance warning shall be given.
NOTE The value of 50 % may be too high for some applications such as ophthalmology and, in such cases, a
smaller value may be required (e.g. 25 %).
201.13.2.102 Failure of exposure termination
When the exposure is terminated by means of a timer, protection against single fault
conditions shall be provided by a safety device which is independent of the timer and is
activated when the set time is exceeded by 20 %. The safety device terminates the LASER
OUTPUT and prevents further timer-dependent operation of the equipment.
NOTE A second timer may be a means of achieving compliance with this requirement.
Exempt from this requirement are CLASS 3B LASERS for non-surgical or non-ophthalmic use
within the wavelength range of 600 nm to 1 400 nm,
a) emitting less than five times the MPE for the skin and not more than 50 mW average
power, or
b) not exceeding the MPE for the skin.
Compliance is checked by inspection and measurements.

This requirement and relevant tests shall not be applied to failures of:
– components which can be regarded as FAIL SAFE and which are subject to preventive
maintenance;
– components of monitoring circuits which are checked during every start-up procedure of
the laser equipment.
– 18 – 60601-2-22 © IEC:2007
201.13.2.103 Failure of components with limited reliability

For instance, the following components shall be regarded as having a limited reliability:

– SHUTTER and/or its means of activation;

– optical attenuators including the OPERATOR PROTECTIVE FILTER and its mechanism;

– LASER EMISSION control switch

– timer for LASER EMISSION;
– components of monitoring circuits.

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the General Standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the General Standard applies, except as follows:
Addition:
201.15.101 TARGET INDICATING DEVICE (see Annex AA, rationale to 201.10.4 f))
Clearly visible indication of the location where the LASER OUTPUT is to have its effect shall be
provided prior to emission of the WORKING BEAM.
Possible solutions include:
a) the use of a visible AIMING BEAM which shall be recognisable through the LASER protective
eyewear;
b) the attachment of a pointer on the hand piece;
c) optical aiming devices;
d) contact application;
e) electronic indication, i.e. a cursor on a screen.
The point of impact indicated by the TARGET INDICATING DEVICE shall be coincident with the
WORKING BEAM. The tolerances for coincidence shall be small enough so as to prevent
maltreatment due to false aiming.

The AIMING BEAM and the WORKING
...