IEC 80601-2-58:2014

INTERNATIONAL ISO/IEC
STANDARD 80601-2-58
NORME
Second edition
Deuxième édition
INTERNATIONALE
2014-09-15
Medical electrical equipment —
Part 2-58:
Particular requirements for basic safety
and essential performance of lens
removal devices and vitrectomy devices
for ophthalmic surgery
Appareils électromédicaux —
Partie 2-58:
Exigences particulières pour la sécurité
de base et les performances essentielles
des dispositifs de retrait du cristallin et
des dispositifs de vitrectomie pour la
chirurgie ophtalmique
Reference number
Numéro de référence
ISO/IEC 80601-2-58:2014(E/F)
©
ISO/IEC 2014
ISO/IEC 80601-2-58:2014(E/F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT

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– 2 – IEC 80601-2-58:2014 © IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents. 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 12
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 13
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
201.15 Construction of ME EQUIPMENT . 21
201.16 * ME SYSTEMS . 21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 22
202 Electromagnetic compatibility – Requirements and tests . 22
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 23
Annex AA (informative) Particular guidance and rationale . 24
Bibliography . 26
Index of defined terms . 27

Figure 201.101 – Test method for gravity fed IRRIGATION . 14
Figure 201.102 – Test method for pressurized IRRIGATION . 15
Figure 201.103 – Test method for ASPIRATION pressure measurement/display accuracy . 16
Figure 201.104 – Test method for ultrasonic velocity of tip accuracy . 18

Table 201.101 – Key of symbols for Figure 201.101 to Figure 201.103 . 16
Table 201.C.101 – ACCOMPANYING DOCUMENTS, instructions for use of LENS REMOVAL
and VITRECTOMY DEVICES or their parts . 23
DEVICES
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-58: Particular requirements for the basic safety
and essential performance of lens removal devices
and vitrectomy devices for ophthalmic surgery

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,
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agreement between the two organizations.
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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 80601-2-58 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice, and subcommittee SC 7: Ophthalmic optics and instruments of ISO technical
committee 172: Optics and photonics.
This second edition cancels and replaces the first edition of IEC 80601-2-58 published in 2008.
It is published as a double logo standard.

– 4 – IEC 80601-2-58:2014 © IEC 2014
The text of this standard is based on the following documents:
FDIS Report on voting
62D/1151/FDIS 62D/1161/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 12 P members
out of 12 having cast a vote.
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.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability 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
LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used widely in ophthalmology to perform
anterior-segment and posterior-segment surgery on the human eye. Commercial use of these
MEDICAL ELECTRICAL EQUIPMENT devices began in the early 1970s. This International Standard
defines particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS
REMOVAL DEVICES and VITRECTOMY DEVICES, comprising an equipment console, surgical
HANDPIECES and ACCESSORIES connected to this ME EQUIPMENT.
In many parts of the world LENS REMOVAL DEVICES and VITRECTOMY DEVICES are used in
combination by ophthalmic surgeons to perform combined anterior-segment (lens removal)
PROCEDURES to maximize surgical outcomes.
and posterior-segment (vitreoretinal) surgical
For this reason both LENS REMOVAL DEVICES and VITRECTOMY DEVICES are covered in this
International Standard.
As all particular standards in the IEC 60601-1 series are based on the general standard
IEC 60601-1, the user of this standard is reminded that RISK MANGEMENT plays an important
role in the use of this particular standard. Compliance with the requirements of this particular
RISK MANAGEMENT FILE to ensure the HAZARDS
standard should be documented in the
associated with the product have been considered fully.

– 6 – IEC 80601-2-58:2014 © IEC 2014
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-58: Particular requirements for the basic safety
and essential performance of lens removal devices
and vitrectomy devices for ophthalmic surgery

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 LENS
REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.208
and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL
ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.
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.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic
surgery (as defined in 201.3.208 and 201.3.217) and associated ACCESSORIES that can be
connected to the ME EQUIPMENT and are to be tested together or individually.
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 201.2 of this particular standard.
IEC 60601-1-2:2007 applies as modified in Clause 202. All other published collateral
standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
The general standard is IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance

In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards 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 clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). 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, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables 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 clause or subclause in this particular standard, the 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.
201.2 Normative references
NOTE Informative references are listed in the bibliography beginning on page 26.
Clause 2 of the general standard applies, except as follows:
Replacement:
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IEC 60601-1-2:2007 , Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
Addition:
IEC 60601-2-2, Medical electrical equipment – Part 2-2: Particular requirements for the basic
safety and essential performance of high frequency surgical equipment and high frequency
surgical accessories
IEC 60601-2-22, Medical electrical equipment – Part 2-22: Particular requirements for the
basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment
ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements
for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006, Packaging for terminally sterilized medical devices – Part 2: Validation
requirements for forming, sealing and assembly processes
ISO 17664:2004, Sterilization of medical devices – Information to be provided by the
manufacturer for the processing of resterilizable medical devices
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1, apply,
except as follows:
NOTE An index of defined terms is found beginning on page 27.
Addition:
201.3.201
ASPIRATION
drawing fluid or gas out of the eye by use of suction
201.3.202
DIATHERMY
surgical technique using high frequency (HF) electrical currents to stop bleeding in tissue
Note 1 to entry: Diathermy is used, for example, to coagulate blood or bind tissues together.
Note 2 to entry: The terms “cautery” or “coagulation” have also been used in this context.
201.3.203
DRAIN CONTAINER
sealed container (or bag) in which aspirated fluid is collected
201.3.204
HANDPIECE
PROBE
handheld APPLIED PART, an ACCESSORY of LENS REMOVAL DEVICES or VITRECTOMY DEVICES

Third edition. Although a new, fourth edition of IEC 60601-1-2 was published in 2014, the normative references
to this collateral standard in the present particular standard refer to the third edition, published in 2007.

201.3.205
LASER
any device which can be made to produce or amplify electromagnetic radiation in the
wavelength range from 180 nm to 1 mm primarily by the process of controlled stimulated
emission
[SOURCE: IEC 60825-1:2007, 3.41]
201.3.206
LASER FRAGMENTATION
method by which the lens is broken into small fragments using LASER energy
201.3.207
LENS REMOVAL
removal of unwanted lens tissue
201.3.208
LENS REMOVAL DEVICE
ME EQUIPMENT or ME SYSTEM designed to remove lens material which incorporates an
IRRIGATION and ASPIRATION function, and a mechanism for LENS REMOVAL such as
PHACOEMULSIFICATION, LIQUEFACTION, or LASER FRAGMENTATION
Note 1 to entry: These devices may also be used for other ocular surgical purposes.
201.3.209
LIQUEFACTION FRAGMENTATION
LIQUEFACTION
method by which the lens is broken into small fragments by means of pulses of ophthalmic
IRRIGATION solution
201.3.210
OCULAR IRRIGATION
IRRIGATION
introduction of a liquid into the eye
Note 1 to entry: The term “infusion” has also been used in this context
201.3.211
PHACOFRAGMENTATION
method by which the lens is broken into small fragments using energy such as from ultrasonic
devices
Note 1 to entry: Refer to the definition of LENS REMOVAL DEVICE in 201.3.208.
Note 2 to entry: Historically PHACOFRAGMENTATION (term is also identified as phacoemulsification) has been a
surgical PROCEDURE that uses ultrasonic energy to fragment (or emulsify) a cataractous lens and removes the lens
material through a small incision. Recently, other emerging energy modalities, including LASER FRAGMENTATION and
LIQUEFACTION, have also been utilized in the removal of the cataractous lens through a small incision.
201.3.212
PHOTORETINITIS
retinal injury resulting from a very intense retinal radiant exposure
201.3.213
PRIME
PRIMING
pre-operative setup PROCEDURE to fill TUBING SET (fluid path) with ophthalmic IRRIGATION
solution
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201.3.214
TIP
hollow needle-like device that is attached to a HANDPIECE
201.3.215
TUBING SET
set of tubes to contain fluid, designed to provide IRRIGATION to the eye and ASPIRATION from
the eye
201.3.216
VITRECTOMY
surgical PROCEDURE to remove vitreous humour, membranes, blood, lens tissue and other
material from the eye, involving IRRIGATION, ASPIRATION and vitreous cutting
Note 1 to entry: The PROCEDURE may also include illumination, DIATHERMY, fluid/gas exchanges, and injection of
viscous fluids.
201.3.217
VITRECTOMY DEVICE
ME EQUIPMENT or ME SYSTEM used to perform VITRECTOMY
Note 1 to entry: These devices may also be used for other ocular surgical purposes.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Addition:
201.4.3.101 General
For LENS REMOVAL DEVICES and VITRECTOMY DEVICES no ESSENTIAL PERFORMANCE has been
LENS REMOVAL DEVICES and VITRECTOMY DEVICES have functions
identified in general. If the
other than those specified in Clause 201.12, the MANUFACTURER shall identify which of these
functions of the ME EQUIPMENT and ME SYSTEMS is ESSENTIAL PERFORMANCE.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
Addition:
201.4.101 * Additional functions
If there is a DIATHERMY function used for the LENS REMOVAL DEVICE and VITRECTOMY DEVICE,
that function shall meet the requirements of IEC 60601-2-2.
ME EQUIPMENT includes a LASER function, that function shall meet the requirements of
If the
IEC 60601-2-22.
If there is an illumination function used to illuminate the eye during surgery that is part of the
ME EQUIPMENT or ME SYSTEM, then that portion of the ME EQUIPMENT or ME SYSTEM shall meet
201.12.4.101.5.
201.5 General requirements for testing of 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:
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally include the following warning and safety notices:
a) a warning to use only recommended TUBING SET(s);
b) if an electrically adjustable ophthalmic IRRIGATION solution support pole is used, a warning
not to modify pole height or manually force the pole height because this could cause
incorrect indication of bottle height and PATIENT injury;
c) a warning never to intentionally modify HANDPIECES or TIPS (e.g. do not bend, cut, or
engrave them) as they could break or malfunction;
d) a warning to the OPERATOR not to touch an activated ultrasonic HANDPIECE TIP, as injuries
could occur;
RISK of injury, ratings of lamp,
e) if applicable, warnings related to lamp replacement (e.g.
damage to lamp, damage to machine, etc.);
f) if applicable, a warning to the OPERATOR that care should be taken to avoid concentrating
the output of an illumination module on a small area of the retina for unnecessarily
PHOTORETINITIS and serious permanent
prolonged periods of time due to the potential for
PATIENT injury;
g) if applicable, a warning to the OPERATOR that inadvertent activation of functions that are
intended for PRIMING or tuning HANDPIECES while the HANDPIECE is in the eye can create a
HAZARDOUS SITUATION that could result in PATIENT injury;
h) where gravity is relevant to performance, the ophthalmic IRRIGATION solution source shall
be at or above the PATIENT’s eye level;
i) a warning to the OPERATOR to ensure sufficient volume of IRRIGATION solution for the
PROCEDURE. The level should be monitored during the PROCEDURE;
j) if applicable, a warning to the OPERATOR to ensure that the maximum capacity of the DRAIN
is not exceeded as this could cause a HAZARDOUS SITUATION to the PATIENT.
CONTAINER
201.7.9.2.8 Start-up PROCEDURE
Addition:
The instructions for use shall include instructions to perform functional checks of the system
before first use of the day.
201.7.9.2.9 Operating instructions
Addition:
The operating instructions shall additionally include:
PRIMING, changing, and reloading the TUBING
a) if applicable, instructions regarding loading,
SET(s), and the TUBING SET(s) change interval to maintain the specified performance;

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b) if applicable, instructions regarding the use of clamps on a TUBING SET, the avoidance of
ophthalmic IRRIGATION solution free flow conditions, and the PROCEDURE to be followed
when changing the ophthalmic IRRIGATION solution source;
c) instructions regarding securely attaching plugs, HANDPIECE cables and other connectors.
201.7.9.2.12 Cleaning, disinfection, and sterilization
Addition:
For parts that are resterilizable, the information for processing shall be in accordance with
ISO 17664:2004. This information shall be provided to the RESPONSIBLE ORGANIZATION or the
OPERATOR.
201.7.9.2.13 Maintenance
Addition:
The instructions for use shall provide the OPERATOR or RESPONSIBLE ORGANIZATION with a
recommendation to inspect all HANDPIECE cables and any cords on a regular basis and a
recommendation as to the action to take if damage (e.g. exposed wire, nicks in the insulation,
deformation, etc.) is observed.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies.
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.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2 Temperature of APPLIED PARTS
201.11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT
Replacement:
HANDPIECES for DIATHERMY, PHACOFRAGMENTATION, LASER and LIQUEFACTION are considered to
be APPLIED PARTS intended to supply heat to a PATIENT.
The temperature or clinical effects shall be determined and documented in the RISK
MANAGEMENT FILE.
201.11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
Addition:
The packaging for terminally sterilized ACCESSORIES for LENS REMOVAL DEVICES and
VITRECTOMY DEVICES shall comply with the requirements of ISO 11607-1:2006. Validation
requirements for forming, sealing, and assembly processes for this packaging shall be
consistent with ISO 11607-2:2006.
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 Additional accuracy of controls and instruments requirements
NOTE Additional requirements for accuracy of controls and instruments are detailed in subclauses 201.12.1.101.1
to 201.12.1.101.5 and 201.12.1.101.7 to 201.12.1.101.9.
201.12.1.101.1 Accuracy of static IRRIGATION pressure
Static IRRIGATION pressure output shall not deviate from the indicated setting on the LENS
REMOVAL DEVICES and VITRECTOMY DEVICES by more than ± 20 % or ± 10 mmHg (± 1,3 kPa)
whichever is greater for a specific device in a defined configuration (see 201.12.4.101.1 for
hazardous output limit).
Compliance is checked by applying the relevant test method(s) 1 and/or 2:
a) Test method 1 (Gravity fed IRRIGATION)
1) Set the test environment temperature to 25 °C ± 5 °C.
2) Install the TUBING SET(S) AND PRIME THE DEVICE IN ACCORDANCE WITH THE
MANUFACTURER’S INSTRUCTIONS FOR USE.
3) Zero the pressure meter reading. Connect the pressure meter to the end of the
IRRIGATION tubing and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.101.
4) Initiate the flow of fluid in accordance with the MANUFACTURER’s instructions for use.
5) Set the gravity feed reservoir height to 0 cm or the lowest setting and record the
pressure meter reading after 5 s.
6) Increase the reservoir height by 20 cm and wait for 5 s and record the pressure meter
reading.
7) Repeat step 6 until the maximum reservoir height is reached.
8) Record the pressure meter reading at the maximum reservoir height.
9) Repeat the readings at the heights used in steps 5, 6 and 7 as the height is decreased
and wait for 5 s and record the pressure meter reading at each point.
10) Confirm that all the readings are within the stated range.

– 14 – IEC 80601-2-58:2014 © IEC 2014
2 3
IEC
For key, see Table 201.101
Figure 201.101 – Test method for gravity fed IRRIGATION
b) Test method 2 (pressurized IRRIGATION)
1) Set the test environment temperature to 25 °C ± 5 °C.
2) Install the TUBING SET(S) AND PRIME THE DEVICE IN ACCORDANCE WITH THE
MANUFACTURER’S INSTRUCTIONS FOR USE.
3) Zero the pressure meter (PM) reading. Connect the pressure meter to the end of the
IRRIGATION TUBING and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.102.
4) Initiate the flow of fluid in accordance with the MANUFACTURER’s instructions for use.
5) Set the test IRRIGATION pressure to 0 mmHg (0 kPa) or lowest setting and record
pressure meter reading after 5 s.
6) Increase the test pressure values by 20 mmHg (2,7 kPa).
7) Wait for 5 s and record pressure meter reading.
8) Repeat step 6 and 7 for test pressure setting in 20 mmHg (2,7 kPa) increments until
the maximum pressure setting is reached.
9) Repeat the readings used in steps 6, 7 and 8 as the pressure is decreased and wait for
5 s and record the pressure meter reading at each point.
NOTE This may involve reconnection of the IRRIGATION tubing for the decreasing measurements.
10) Confirm that all the readings are within the stated range.

2 3
IEC
For key, see Table 201.101
Figure 201.102 – Test method for pressurized IRRIGATION
201.12.1.101.2 Accuracy of ASPIRATION pressure
ASPIRATION pressure output shall not deviate from the indicated setting on the LENS REMOVAL
DEVICES and VITRECTOMY DEVICES by more than ± 20 % or ± 30 mmHg (± 4 kPa) whichever is
greater (see 201.12.4.101.2 for hazardous output limit).
Compliance is checked using the following test method:
Test method: ASPIRATION pressure measurement/display accuracy
1) Install a new TUBING SET to device under test. PRIME the TUBING SET.
2) Zero the pressure meter (PM) reading. Connect the pressure meter to the end of the
ASPIRATION TUBING and position the pressure meter within ± 2,5 cm of the simulated
PATIENT eye level, see Figure 201.103.
3) In the ASPIRATION mode adjust the vacuum preset to 50 mmHg (6,7 kPa).
4) For flow-based system, set flow rate at least to 10 ml/min.
5) Depress (foot) control to activate aspiration vacuum.
6) Record the pressure meter reading and the vacuum value displayed on the instrument
after 5 s.
7) Repeat step 5 and 6 for the test pressure values at 100 mmHg (13,3 kPa) increments
steps to the maximum designed vacuum.
8) Repeat the tests of step 7 in the reverse order of pressure values.
9) Confirm that all the readings are within the stated range.

– 16 – IEC 80601-2-58:2014 © IEC 2014
2 3
IEC
For key, see Table 201.101
Figure 201.103 – Test method for ASPIRATION pressure measurement/display accuracy
Table 201.101 – Key of symbols for Figure 201.101 to Figure 201.103
1 Equipment under test
2 Pressure meter
PATIENT eye level
4 IRRIGATION tube
5 Reservoir hanger
Gravity feed reservoir
7 Spike
8 Reservoir
Pressurized IRRIGATION TUBING SET

10 ASPIRATION tube
201.12.1.101.3 Accuracy of DIATHERMY power
If a DIATHERMY function is provided, the total output power and the actual power as a function
of the load resistance shall comply with the requirements of IEC 60601-2-2 (see
201.12.4.101.3 for hazardous output limit).
Compliance is checked using the following test method: Test according to the requirements of
IEC 60601-2-2 and verify the readings are within ranges identified in subclause
201.12.4.101.3 for the DIATHERMY power.
201.12.1.101.4 Accuracy of DIATHERMY frequency
If a DIATHERMY function is provided, the DIATHERMY frequency output shall not deviate by more
than ± 20 % from the NOMINAL frequency stated in the instructions for use (see 201.12.4.101.4
for hazardous output limit).
Compliance is checked using the following test method: Connect the DIATHERMY driver signal
to an oscilloscope using a high frequency 100X and high impedance 10 MΩ oscilloscope
probe.
201.12.1.101.5 Accuracy of illumination output
If an illumination function is provided, for settings between 20 % or the lowest setting,
whichever is the greater, and maximum output, then the illumination output shall not deviate
by more than ± 25 % from the displayed or marked value on the device.
Compliance is checked using the following test method:
1) Attach illumination HANDPIECE connector to the illumination source.
2) Insert distal end of the illumination HANDPIECE into an integrating sphere photometer.
3) Turn on illuminator and adjust output to maximum.
4) Take the reading after 15 min.
5) Repeat the steps above with illuminator output adjusted to 75 %, 50 %, and 25 % of the
maximum.
6) Confirm that all the readings are within the stated range.
201.12.1.101.6 * Fragmentation
The LENS REMOVAL DEVICES and VITRECTOMY DEVICES can include one or more fragmentation
functions. Apply the relevant requirements and test methods from subclauses 201.12.1.101.7
to 201.12.1.101.9.
MANUFACTURER shall determine through the RISK MANAGEMENT PROCESS if one or more TIP
The
configurations, representing all marketed configurations, are required for testing. Selection of
the appropriate TIP configurations for testing shall be confirmed by checking the RISK
MANAGEMENT FILE. Any TIP configuration(s) used for testing shall be specified in the
instructions for use with the specified performance.
201.12.1.101.7 Accuracy of ultrasonic velocity of TIP
If the ultrasonic velocity is not specified in the instruction for use, measurement of the
ultrasonic velocity of the tip is not required. If an ultrasonic fragmentation function is provided,
the ultrasonic velocity of the TIP shall not deviate by more than ± 20 % from the NOMINAL
value(s) stated in the instructions for use for each listed configuration (see 201.12.4.101.7 for
hazardous output limit).
Compliance is checked using the following test method:
1) Determine stroke:
a) Setup the test per Figure 201.104
b) Focus microscope on a point not more than 1,0 mm from the free end of the applicator
tip, which shall be illuminated by a light beam.
c) Measure and record its diameter. This will be used for measuring the stroke length.
d) When equipment is energized, the point traces a line. The relative orientation of the
applicator tip and the microscope shall be altered until the maximum line length is
observed.
e) The line length (stroke trace), equal to the primary tip vibration excursion to be
measured to an accuracy of 10 % by means of calibrated eyepiece reticule or
micrometer movement.
f) Record the stroke length by subtracting the spot diameter from the stroke trace.
g) If transverse (torsional) vibrations occur simultaneously, then the point on the
applicator describes an elliptical path and length of the major axis of the ellipse shall
be measured.
2) Determine frequency:
– 18 – IEC 80601-2-58:2014 © IEC 2014
a) connect the ultrasonic driver signal to an oscilloscope using a high frequency 100X
and high impedance 10 MΩ oscilloscope probe;
b) verify that the values displayed by the device are within ± 20 % of the NOMINAL value(s)
for the ultrasonic frequency(ies);
3) Determine velocity:
a) multiply stroke by frequency by π to obtain velocity of device under test.
Geometric
axis of tip
Direction of
secondary
tip excursion
Spot of reflected
light as seen
Light
through scope
beam
Direction of
primary tip
vibration
excursion
Microscope
Spot traces a straight
line when tip is
vibrating and there is
no secondary
(transverse) excursion
Spot traces an
elliptical line when the
tip has combined
primary (longitudinal)
and secondary
(transverse) excursion
IEC
Figure 201.104 – Test method for ultrasonic velocity of tip accuracy
201.12.1.101.8 Accuracy of velocity of fluid entering eye for LIQUEFACTION
If a LIQUEFACTION function is provided, the velocity of fluid entering the eye for LIQUEFACTION
shall not deviate by more than ± 20 % from the values stated in the instructions for use for
each listed configuration (see 201.12.4.101.8 for hazardous output limit).
Compliance is checked using one of the following test methods:
Method A:
1) Set up the device under test for LIQUEFACTION mode.

2) Position force or pressure transducer distal to the LIQUEFACTION TIP. Place force or
pressure transducer perpendicular to the TIP axis at a distance between 0,5 mm and
1,0 mm. (Transducer accuracy shall be within 5 % of the measurement.)
3) Set the device under test into pulsing function.
4) Measure the time past, in µs, from any accessible trigger point to when force or pressure
is first indicated on the transducer. A recommended trigger point is the initiation of the
electrical power pulse.
5) Stop the pulsing function.
6) Move the transducer a controlled distance between 0,5 mm and 1,0 mm from the
LIQUEFACTION TIP on the axis of the TIP.
7) Set the device under test into pulsing function.
8) Measure the time, in microseconds, from the same trigger point to when force or pressure
is first indicated on the transducer.
9) Stop the pulsing function.
10) Calculate the fluid velocity by dividing the exact difference in transducer position by the
exact difference in time.
Method B:
1) Set up the device under test for LIQUEFACTION mode.
2) Position the tip of liquifaction tip (vertically) into a small beaker on graduation line 200 ml,
and adjust to focusing the high speed camera.
3) Set the device under test into pulsing function at 100 %.
4) Record for 30 s to 45 s.
5) Stop the pulsing function.
6) Replay the recorded segment in slow speed (frame by frame) and measure the time in µs
at the time liquid exits the tip to the next graduation 175 ml or 150 ml. Distance from
175 ml to 200 ml is approximate 6 mm to 7 mm.
7) Calculate the fluid velocity Vy = (∆y + ½ gt2 )/ t, where:
g = 9,8 m/s
∆y = travelling distance (m)
t = time from exiting of the tip to the next graduation (s)
201.12.1.101.9 Accuracy of VITRECTOMY PROBE cut rate
If a VITRECTOMY function is provided, the indicated cut rate and actual cut rate shall not
deviate by more than ± 20 % from each other or from the limits stated in the instructions for use
for each listed configuration (see 201.12.4.101.9 for hazardous output limit).
Compliance is checked using the following test method:
1) Connect VITRECTOMY PROBE to device under test and position under a microscope to
observe the port of the VITRECTOMY PROBE.
2) Set a stroboscope flash rate to ± 10 % of the cut rate set on the device under test.
3) Activate the VITRECTOMY PROBE and the stroboscope.
4) Adjust the flash rate of stroboscope to freeze the motion of the cutter in the port.
5) Read the stroboscope frequency to determine the measured cut rate.
6) The difference between the cut rate set on the device under test and the measured cut
rate shall not be more than ± 20 %.

– 20 – IEC 80601-2-58:2014 © IEC 2014
201.12.4 Protection against hazardous output
Addition:
201.12.4.101 Additional requirements for protection against hazardous output
NOTE Additional requirements for protection against hazardous output, in NORMAL CONDITION, are detailed in
subclauses 201.12.4.101.1 to 201.12.4.101.5 and 201.12.4.101.7 to 201.12.4.101.9. The ranges stated in these
subclauses may be able to be exceeded based on the MANUFACTURER’s RISK MANAGEMENT.
201.12.4.101.1 Hazardous output for static IRRIGATION pressure
The static IRRIGATION pressure output for ME EQUIPMENT shall not exceed 200 mmHg
(26,7 kPa).
Compliance is checked using methods 1 and/or 2 in subclause 201.12.1.101.1 as appropriate
and verify the reading is within the limit as identified above.
201.12.4.101.2 Hazardous ou
...