IEC 60601-2-2:2017/AMD1:2023/ISH1:2025
(Amendment)Interpretation Sheet 1 - Amendment 1 - 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
Interpretation Sheet 1 - Amendment 1 - 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
Feuille d'interprétation 1 - Amendement 1 - Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence
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Standards Content (Sample)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
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IEC 60601-2-2
Edition 6.0 2017-03
Amendment 1 2023-02
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
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by subcommittee 62D: Particular medical
equipment, software, and systems, of IEC technical committee 62: Medical equipment,
software, and systems.
The text of this interpretation sheet is based on the following documents:
DISH Report on voting
62D/2255/DISH 62D/2274/RVDISH
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
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Interpretation of 201.3.223, 201.3.224, 201.4.1.101, 201.7.9.2.2.101 i), 201.7.9.2.14 k),
202.7.1.2 and the rationales to 201.4.1.101, 201.7.9.2.2.101 i), 201.7.9.2.14 k), Clause 202 of
IEC 60601-2-2:2017 and IEC 60601-2-2:2017/AMD1:2023.
This interpretation sheet is intended to clarify the requirements for EMC testing and
compatibility.
Definition 201.3.223 HF SURGICAL ACCESSORY
The requirements in this definition of IEC 60601-2-2:2017 are clarified by the following.
The IEC 60601-2-2:2017 defined term HF SURGICAL EQUIPMENT does not modify the IEC 60601-
1 definition of medical electrical equipment.
ICS 11.040.30
IEC 60601-2-2:2017-03/AMD1:2023-02/ISH1:2025-11(en-fr)
Definition 201.3.224 HF SURGICAL EQUIPMENT
The requirements in this definition of IEC 60601-2-2:2017 are clarified by the following.
HF SURGICAL ACCESSORIES are not HF SURGICAL EQUIPMENT. This standard defines HF SURGICAL
EQUIPMENT and HF SURGICAL ACCESSORY uniquely.
Subclause 201.4.1.101 * Additional conditions for application
The requirements in this subclause of IEC 60601-2-2:2017 are clarified by the following.
It does not exempt HF SURGICAL EQUIPMENT from the requirements of IEC 60601-1-2.
It does not exempt HF SURGICAL ACCESSORIES from the requirements of IEC 60601-1-2.
Subclause 201.7.9.2.2.101 Additional information in instructions for use
The requirements in this subclause of IEC 60601-2-2:2017 and
IEC 60601-2-2:2017/AMD1:2023 are clarified by the following.
i) This subclause only requires the manufacturer to provide the length.
Subclause 201.7.9.2.14 *ACCESSORIES, supplementary equipment, used material
The requirements in this subclause of IEC 60601-2-2:2017 and
IEC 60601-2-2:2017/AMD1:2023 are clarified by the following.
k) This subclause only requires the manufacturer to provide the length.
Subclause 202.7.1.2 Operating modes
The requirements in this subclause of IEC 60601-2-2:2017 are clarified by the following.
Subclause 202.7.1.2 does not exempt HF SURGICAL ACCESSORIES from the requirements of
IEC 60601-1-2, particularly the configuration requirements of subclause 4.3.1.
While HF SURGICAL EQUIPMENT actually meets the definition of CISPR 11 Group 2 equipment,
subclause 202.7.1.2 specifies (as does CISPR 11) that when switched on and in idle state, HF
SURGICAL EQUIPMENT should meet the limits of CISPR 11 Group 1. For this reason, the
accompanying documents should state the limits with which the HF SURGICAL EQUIPMENT
complies, but should also state that it is CISPR 11 Group 2 equipment.
Annex AA
(informative)
Particular guidance and rationale
AA.2 Rationale for particular clauses and subclauses
Subclause 201.4.1.101 Additional conditions for application
The rationale to this subclause of IEC 60601-2-2:2017 is clarified by the following.
It does not exempt HF SURGICAL EQUIPMENT from the requirements of IEC 60601-1-2.
It does not exempt HF SURGICAL ACCESSORIES from the requirements of IEC 60601-1-2.
Subclause 201.7.9.2.2.101 i) Additional information in instructions for use
The rationale to this subclause of IEC 60601-2-2:2017 is clarified by the following.
i) The last paragraph points out that the whole configuration is relevant for EMC results.
Configuration is to be understood according to the description in IEC 60601-1-2:2014,
4.3.1. Not only the length, but also the type of HF SURGICAL ACCESSORIES is relevant.
Type includes, but is not limited to, the materials and construction, electrical
components, electrical circuits, and impedance.
Subclause 201.7.9.2.14 *ACCESSORIES, supplementary equipment, used material
The rationale to this subclause of IEC 60601-2-2:2017 and IEC 60601-2-2:2017/AMD1:2023 is
clarified by the following.
k) This informative content does not communicate that EMC is the only consideration with
respect to compatibility between HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES.
It does not imply that the maximum length is the worst-case length condition with regard
to EM EMISSIONS or IMMUNITY.
It does not imply that the HF SURGICAL ACCESSORY length is the only condition for
determination of electromagnetic compatibility between the HF SURGICAL EQUIPMENT and
the HF SURGICAL ACCESSORY.
Clause 202 – ELECTROMAGNETIC DISTURBANCES – Requirements and tests
The rationale to this clause of IEC 60601-2-2:2017 and IEC 60601-2-2:2017/AMD1:2023 is
clarified by the following.
– Paragraph 6 points out that the maximum permissible length of HF SURGICAL ACCESSORY is
derived from the least favorable configuration according to the description in
IEC 60601-1-2:2014, 4.3.1. Other parameters could also affect the EM EMISSIONS and
IMMUNITY of the ME SYSTEM.
– Paragraph 6 is not intended to imply that the maximum permissible length is considered the
least favorable configuration according to IEC 60601-1-2:2014, 4.3.1.
– Paragraph 7 is not intended to imply that no EMC assessment is necessary.
– Paragraph 9 points out that the OPERATOR has the responsibility to ensure that the length of
HF SURGICAL ACCESSORY is not violating the maximum permissible length specified by the
manufacturer of the HF SURGICAL EQUIPMENT. 201.7.9.2.2.101 i) and 201.7.9.2.14 k) provide
the requirements for MANUFACTURERS to include information so that the OPERATOR can
manage the combination of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES.
– Paragraph 9 is intended to clarify that the OPERATOR’S responsibility is to ensure a
compatible combination of HF SURGICAL ACCESSORIES and HF SURGICAL EQUIPMENT is used
that is in line with EMC compliance requirements. This is intended to be basic information
provided by the MANUFACTURERS for making such combinations. The provision of
information, along with EMC compliance, is the responsibility of each MANUFACTURER of HF
SURGICAL ACCESSORIES and HF SURGICAL EQUIPMENT.
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
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IEC 60601-2-2
Édition 6.0 2017-03
Amendement 1 2023-02
Appareils électromédicaux -
Partie 2-2: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'électrochirurgie
à courant haute fréquence et des accessoires d'électrochirurgie
à courant haute fréquence
FEUILLE D'INTERPR É T AT I O N 1
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