IEC 60601-2-2-2017 amd1-2023 ISH1-2025

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IEC 60601-2-2:2017/AMD1:2023/ISH1:2025 © IEC 2025

ICS 11.040.30

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________

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.

___________

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.

IEC 60601-2-2:2017-03/AMD1:2023-02/ISH1:2025-11(en-fr)

IEC 60601-2-2:2017/AMD1:2023/ISH1:2025 © IEC 2025

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.

IEC 60601-2-2:2017/AMD1:2023/ISH1:2025 © IEC 2025

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.

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摘要：

IEC 60601-2-2-2017 amd1-2023 ISH1-2025 是国际电工委员会（IEC）发布的针对医用电气设备第2-2部分的专门标准，覆盖高频手术设备及高频附件的基本安全和基本性能要求。该版本整合了2017年主标准、2023年第一次修订（amd1）以及2025年发布的第一次解释条款（ISH1），旨在明确高频手术设备在电磁兼容、患者防护、防灼伤及输出控制等方面的最新技术要求。对于医疗器械制造商、检测认证机构及医院设备管理人员而言，此标准是确保高频电刀、射频消融设备等产品合规上市与安

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