IEC 80601-2-58:2014/AMD1:2016
(Amendment)Amendment 1 - 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
Amendment 1 - 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
This standard specifies:[
]- the essential non-thermal output characteristics of ultrasonic surgical units;[
]- methods of measurement ot these output characteristics;[
]- those characteristics which should be declared by the manufacturers of such equipment.[
]This standard is applicable to equipment which meets the requirements of a, b and c below:[
]a) ultrasonic surgical systems operating in the frequency range 20 kHz to 60 kHz; and[
]b) ultrasonic surgical systems, whose use is the fragmentation or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and[
]c) ultrasonic surgical systems, in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site.
Amendement 1 - 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
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IEC 80601-2-58
Edition 2.0 2016-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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
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
IEC 80601-2-58:2014-09/AMD1:2016-10(en-fr)
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IEC 80601-2-58
Edition 2.0 2016-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.70 ISBN 978-2-8322-3568-3
– 2 – IEC 80601-2-58:2014/AMD1:2016
© IEC 2016
FOREWORD
This amendment 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.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1364/FDIS 62D/1370/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. In ISO, the standard has been approved by 11
P members out of 11 having cast a vote.
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 TO THE AMENDMENT
This amendment modifies the content of the second edition of IEC 80601-2-58 published in
2014. This Amendment constitutes a technical revision.
This amendment includes the following significant technical changes with respect to the
second edition:
a) integration of updated definition of ESSENTIAL PERFORMANCE and updating the ESSENTIAL
PERFORMANCE analysis;
b) undating collateral and general standard references to align with amendments to the
general standard and other collateral standards;
c) addition of symbols to standard;
d) update of EMC requirements.
___________
201.1.3 Collateral standards
Replace the existing title of this subclause by the following new title:
201.1.3 * Collateral standards
Replace the existing text of the second paragraph by the following:
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-10,
IEC 60601-1-11, and IEC 60601-1-12 do not apply.
© IEC 2016
201.1.4 Particular standards
Add, in the fourth paragraph of the subclause, "IEC" before the existing references to "60601-
1-2" and "60601-1-3".
Add, in the second sentence of the eight paragraph of the subclause, a comma immediately
after “However”.
201.2 Normative references
Delete the second footnote of the standard.
Replace the existing reference to IEC 60601-1-2, by the following new reference:
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
Add, before the existing reference to ISO 11607-1, the following new reference:
CISPR 11, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics – Limits and methods of measurement
Add, in the following references, the reference to Amendment 1 "AMD1:2014":
ISO 11607-1:2006/AMD1:2014, Packaging for terminally sterilized medical devices – Part 1:
Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006/AMD1:2014, Packaging for terminally sterilized medical devices – Part 2:
Validation requirements for forming, sealing and assembly processes
201.3.205
Replace the existing source by the following new source and add the end of page footnote as
follows:
[SOURCE: IEC 60825-1:2014, 3.44 [1] ]
Numbers in square brackets refer to the Bibliography.
201.3.208
LENS REMOVAL DEVICE
Replace the existing definition by the following, without modifying the existing Note to entry:
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
PHACOFRAGMENTATION, LIQUEFACTION, OR LASER FRAGMENTATION
201.7 ME EQUIPMENT identification, marking and documents
Add, after the instruction for subclause 201.7, the following new subcause:
– 4 – IEC 80601-2-58:2014/AMD1:2016
© IEC 2016
201.7.6.101 * Additional symbols
Addition:
Symbols for LENS REMOVAL and VITRECTOMY.
If symbols for LENS REMOVAL and VITRECTOMY devices that have functions such as DIATHERMY,
FRAGMENTATION, LIQUEFACTION FRAGMENTATION, VITRECTOMY, and illumination are used, they
shall be based on the recommended symbols of Annex D and be on the device or near the
connection point of the function.
201.7.9.2.12 Cleaning, disinfection, and sterilization
Add, at the end of the last sentence of the subclause, the following reference: [2].
201.11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS
Replace, in the existing text, the references to ISO 11607-1:2006 and ISO 11607-2:2006 by
"ISO 11607-1:2006/AMD1:2014" and "ISO 11607-2:2006/AMD1:2014" respectively.
201.12.1.101.7 Accuracy of ultrasonic velocity of TIP
Replace the first paragraph by the following:
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. In the case that the
ultrasonic velocity is not specified in the instruction for use, measurement of the tip stroke
exiting the tip or equivalent shall be made to assure the ultrasonic fragmentation function
meets the hazardous output limit (see 201.12.4.101.7 for hazardous output limit).
Add, after the end of item 1) in the list, the following reference to the bibliography "[3]".
Replace the existing text in test method step 2) b) by the following:
b) verify that the values displayed by the oscilloscope are within ± 20 % of the NOMINAL
value(s) for the ultrasonic frequency(ies);
201.12.1.101.8 Accuracy of velocity of fluid entering eye for LIQUEFACTION
Replace the first paragraph by the following:
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. In the case that the velocity of fluid entering the eye for
LIQUEFACTION is not specified in the instruction for use, measurement of the fluid velocity or
equivalent shall be made to assure the LIQUEFACTION function meets the hazardous output
limit (see 201.12.4.101.8 for hazardous output limit).
© IEC 2016
Replace the formula in Method B, item 7) by the following:
Vy = (∆y + ½ gt )/ t
201.13 Hazardous situations and fault conditions for ME EQUIPMENT
Replace the existing title of this subclause by the following new title:
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
202 Electromagnetic compatibility – Requirements and tests
Replace the complete text of Clause 202 by the following text:
202 Electromagnetic disturbances – Requirements and tests
IEC 60601-1-2 applies except as follows:
202.5.2.2.2 * Requirements applicable to ME EQUIPMENT and ME SYSTEMS specified for
use only in a shielded location SPECIAL ENVIRONMENT
Subclause 5.2.2.2 of IEC 60601-1-2 does not apply.
202.5.2.2.4 Requirements applicable to ME EQUIPMENT that includes RF transmitters
Addition:
If there is a DIATHERMY function, its output shall not be considered an RF transmitter.
LECTROMAGNETIC EMISSIONS requirements for ME EQUIPMENT and ME SYSTEMS
202.7 E
202.7.1.2 Operating modes
Insert, after the first paragraph, the following text:
aa) If there is a DIATHERMY function, it shall not be tested for radiated or conducted RF
EMISSIONS when the HF output
...
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