Pacemaker uses communication technologies such as Short Range Devise (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 pacemaker testing process is stated in the Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024 for SRD which regulates various technical aspects, ranging from radio frequency, and transmit power, to testing methods.
SRD technology, which is widely used in pacemaker devices must comply with this standard to be used legally in Indonesia.
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New Regulations on Pacemaker Technology
This regulation covers radio frequency requirements, maximum transmit power, and testing for wild emissions (spurious emissions).
Ministerial Decree 260 of 2024
The following are the standard specifications for SRD:
| Radio Frequency Band | Field strength / RF output power | Transmitter Spurious Emission | Testing Method | Other Condition | SRD Application |
| 9 – 135 kHz | ≤ 30 dBµA/m at 10 meters ditance | EN 302 195 | EN 302 195 | Duty cycle ≤ 10% | Medical and Biological telemetry |
| 402 – 405 MHz | ≤ 25μW ERP | EN 301 839 | EN 301 839 | – | Active medical implant device |
Pacemaker Testing Standard
Ministerial Decree 260 of 2024
Pacemaker is carried out to ensure the device meets technical standards Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024. Here are some of the main points in the test:
Radiofrequency testing
- Purpose: Ensure Bluetooth devices function without interfering with other devices using the same radio frequency.
- Method: Using FCC 15.247 or EN 300 328 standards to measure transmit power (RF output power).
Transmit power testing (RF output power)
- Objective: Assess whether the device transmits power below the 20 dBm ERP maximum limit or the maximum limit of 94 dBµV/m at a distance of 10 meters.
- Method: Using measuring instruments such as a spectrum analyzer to measure the device’s transmit power.
Wild emissions testing (spurious emissions)
- Purpose: Ensure the device does not produce emissions outside its working frequency band that could interfere with other devices.
- Standard: Refer to FCC 15.209 or EN 302 291.
Electromagnetic compatibility (EMC) testing
- Purpose: Assess device compatibility with the surrounding electromagnetic environment to prevent interference.
- Method: Referring to international standards such as EN 301 489.
Pacemaker Certification Process in Indonesia
For pacemaker 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, the gadget will be sent to an assigned official research facility to experience testing according to the guidelines stipulated in the Ministerial Decree of the Ministry of Communication and Digital No. 260 of 2024.
Issuance of certificates
After the device passes testing, an official certificate will be issued by DJID. This certificate is a requirement 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.
- Counsel a master: If this is your to begin with time looking for certification, consider utilizing the administrations of experienced DJID certification administrations.
