工業科學醫療用電波輻射性電機管理辦法

The regulations hereunder are promulgated pursuant to Paragraph 4, Article 48 of the Telecommunications Act.

The administration of industrial, scientific, medical radio bands equipment (the “ISM equipment”) shall follow regulations hereunder. The matters not provided herein shall be prescribed in accordance with other laws and regulations..

Industrial, scientific, and medical (ISM) equipment refers to equipment or appliances designed to generate or transform locally RF energy for industrial, scientific, medical, or other similar purposes, excluding applications in the field of telecommunications. Typical ISM applications are such as industrial heating equipment, ultrasonic equipment, diathermy or magnetic resonance equipment, and other electrical appliances but shall exclude those for home use.

1Definitions and scope shall be as follows:

24.1 Radio frequency (RF) energy:

3Electromagnetic energy at any frequency in the radio spectrum from 8.3 kHz to 3 THz.

44.2 Diathermy or magnetic resonance medical equipment:

5A category of ISM equipment in which RF energy is created by utilizing a radio-frequency oscillating machine or other forms of radio-frequency generator for therapeutic purposes. Or use of RF energy to create images and data representing spatially resolved density of transient atomic resources within an object but not including surgical diathermy apparatus designed for intermittent operation with low power.

64.3 Industrial heating equipment:

7A category of ISM equipment used for or in connection with industrial heating operations utilized in a manufacturing or production process.

84.4 Other electrical equipment:

9Equipment other than 4.2 and 4.3, which utilizes RF energy for the production of physical, biological, or chemical effects such as heating, ionization of gases, mechanical vibrations, hair removal and acceleration of charged particles excluding applications in the field of telecommunication or wireless receiving devices.

The competent authority of regulations hereunder shall be the National Communications Commission (NCC).

ISM equipment shall adhere to regulations set by the Ministry of Economic Affairs (“MOEA”) EMC regulations. Installation shall be permitted only after obtaining approval. However, it does not apply to those falling beyond the scope of approval items.

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1Except for the research purposes of a research organization, ISM equipment shall not be modified or changed for purpose of use.

2Prior to any modification prescribed in the preceding paragraph, a shielding facility shall be securely installed.

1The operating frequencies, operating band ranges, and radiation field strength used in ISM equipment shall accord with CNS standards.

2The radiation field strength of ISM equipment using the following operating frequencies and band ranges is unlimited.

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4Operating center frequency Tolerance

5-------------------------------------------------------------------------------

611.1 13,560 kHz................................. ±7.0 kHz

711.2 27,120 kHz................................. ±163.0 kHz

811.3 40.680MHz................................ ±20.0 kHz

911.4 2,450 MHz................................. ±50.0 MHz

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The operation of ISM equipment shall not endanger the functioning of frequency bands for radio navigation or other safety services as below：490-510 kHz, 2170-2194 kHz, 8354- 8374 kHz, 121.4-121.6 MHz, 156.7-156.9 MHz, and 242.8-243.2 MHz.

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The radiation field strength of ISM equipment shall not be strong enough to harm the human body.

1The management of ISM equipment shall adhere to the following:

215.1 In order to operate and manage wireless industrial heating equipment which generate radio waves by utilizing resonance, full-time personnel qualified in electronic or electrical engineering, graduating from senior high school or above shall be hired.

315.2 The radio frequency devices for scientific research purposes shall be managed by qualified personnel with a title of college lecturer or higher. While the equipment is in use, said personnel shall be responsible for on site instruction.

415.3 Medical ultrasonic equipment, diathermy or magnetic resonance medical equipment shall be operated and managed by dedicated doctor or specialist knowledgeable in radio waves .

The ISM equipment manufacturer shall provide a detailed description of technical specifications and test records for inspection and reference basis once interference has occurred.

1The installation of ISM equipment shall meet the following requirements:

217.1 The frequency stability shall be sufficient in compliance with the Telecommunications Act and relevant regulations.

317.2 Utilizing appropriate radio waves shielding facility.

417.3 It shall be grounded in the main power line connecting point.

The operation of ISM equipment endangering the functioning of a radio navigation or safety service shall be stopped immediately upon notification by the competent authority. Operation may be resumed, under the supervision of the competent authority, only after the harmful interference has been eliminated and approval from the competent authority has been obtained. However, it does not apply to operation resumed subject to the consent of the competent authority on a temporary basis for the purpose of examining the cause of the harmful interference.

1Upon receiving notification from the competent authority, the operation of ISM equipment endangering or continuously interrupting legal communications other than radio navigations or safety services shall be instructed with the following:

219.1 operation shall be ceased immediately: Operator shall immediately cease operating the equipment upon notification of the competent authority and take appropriate measures per previous article.

319.2 continuous operation is allowed: Operator shall complete corrective action within 10 days after receiving notification. If corrective action is not completed within the prescribed period, the operator may apply to the competent authority for an extension, which may be granted depending on the examination of the case by the competent authority.

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Punitive measures for violations of regulation hereunder shall be prescribed as per Telecommunications Act.

The Regulations shall become effective as of the date of promulgation.