Ambulatory Blood Pressure Monitoring (ABPM) uses communication technologies such as Bluetooth or (Short Range Devices) SRD that operate within a specific frequency spectrum. This technology must meet the main requirements through a standard testing process to ensure its quality, security, and compliance with applicable regulations.
This standard ambulatory blood pressure monitoring testing process is stated in the Ministerial Decree of the Ministry of Communication and Digital No. 260 which regulates various technical aspects, ranging from radio frequency, and transmit power, to testing methods.
Bluetooth or SRD technology, which is widely used ambulatory blood pressure monitoring devices must comply with this standard to be used legally in Indonesia.
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New Ambulatory Blood Pressure Monitoring Technology
Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024 sets technical standards that must be met by ambulatory blood pressure monitoring devices to be used legally in Indonesia.
This regulation covers radio frequency requirements, maximum transmit power, and testing for wild emissions (spurious emissions).
The following are the standard specifications for Bluetooth:
| Radio Frequency Bands | Maximum Transmit Power | Spurious Emission Transmitter | Test Method |
| 2400-2483,5 MHz | ≤ 20dBm EIRP | FCC 15.247 and/or 15.209 | FCC 15.247 and ANSI C63.10 |
| EN 300 440 | EN 300 440 | ||
| EN 300 328 | EN 300 328 |
The following are the standard specifications for Medical and Biological telemetry:
| Radio Frequency Band | Field strength / RF output power | Transmitter Spurious Emission | Testing Method | Other Condition |
| 9 – 315 kHz | ≤ 23 dBmA/m at 10 meters distance | EN 302 195 | EN 302 195 | Duty cycle ≤ 10% |
| 40.5 – 41 MHz | ≤ 0.01 mW ERP | EN 300 220-1 | EN 300 220 | – |
| 216 – 217 MHz | ≤ 112 dBV/m at 10 meters distance | EN 300 422 | EN 300 422 | – |
Ambulatory Blood Pressure Monitoring Testing Standards
Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024 refers to international standards-based test methods such as FCC, EN, and ANSI. Here are some of the main testing methods:
- Transmit power testing (RF output power): Ensure the device does not exceed the maximum transmit power limit according to its frequency band.
- Spurious emission testing: Tests stray frequency emissions outside the working band to prevent interference with other devices.
Electromagnetic Compatibility (EMC) Testing: Assesses the device’s compatibility with the surrounding electromagnetic environment to avoid interference.
Additional technical requirements
Apart from testing transmittance and emissions, the Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024 also regulates several other technical requirements, including:
- Electrical safety: The device must comply with the electrical safety standards set out in SNI IEC 60950-1:2016; SNI IEC 62368-1:2014; SNI 04-6253; IEC 62368-1; IEC 60950-1; IEC 60065; or relevant SNI or IEC standards, for SRD other than audio, video and information and communication technology (ICT).
- Non-Ionizing Radiation: Controls device radiation levels to keep them safe for users and the environment.
Ambulatory Blood Pressure Monitoring Certification Process in Indonesia
For ambulatory blood pressure monitoring devices to be used legally in Indonesia, certification from DJID is required. Here are the steps to get it:
Pre-testing the device
Before official testing, the device must be pre-tested first using measuring equipment such as a spectrum analyzer.
This helps ensure devices meet technical standards before being tested in authorized laboratories.
Testing at an official laboratory
After passing the pre-testing stage, the device will be sent to a designated official laboratory to undergo testing by the standards stipulated in the Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024.
Issuance of certificates
After the device passes testing, DJID will issue an official certificate. This certificate is required to market the device legally in Indonesia.
Tips to ensure standards compliance
- Learn the latest regulations: Make sure you understand every detail of the Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024, including technical requirements and test methods.
- Perform pre-testing: Before official testing, perform pre-testing to ensure the device meets standards. If you don’t have a measuring instrument, use the DJID certification service which provides pre-testing services.
- Consult an expert: If this is your first time seeking certification, consider using experienced DJID certification services.
