On April 24, 2026, the Japanese Standards Association （JSA） officially released the new medical pressure sensor standard JIS T 0901:2026. This standard significantly tightens electromagnetic compatibility （EMC） immunity requirements, particularly by raising the radio-frequency immunity threshold in MRI environments to 300 V/m, and mandating the submission of complete third-party EMC test raw data packages. The standard will become mandatory from October 2026. Medical device exporters, ODM manufacturers, sensor manufacturers, and supply chain service providers should pay close attention to its substantial impact on compliant delivery, testing and validation, and market access.

Event Overview

The Japanese Standards Association （JSA） released the JIS T 0901:2026 standard on April 24, 2026, replacing the previous JIS T 0901:2018 edition. The new standard fully adopts the EMC immunity requirements of IEC 60601-1-2 Edition 4, and raises the immunity threshold in typical MRI radio-frequency field environments from approximately 100 V/m in the previous standard to 300 V/m; at the same time, it for the first time mandates that manufacturers provide Japanese customers or regulators with complete third-party EMC test raw data packages （including test setups, calibration records, original waveform files, etc.）. The standard will be mandatorily implemented from October 1, 2026. As of the release date, only 3 Chinese medical pressure sensor manufacturers had completed pre-testing.

Which market segments will be affected

Medical sensor manufacturers

Because the standard directly regulates both product performance and the testing evidence chain, manufacturers need to reassess the anti-interference capability of existing designs, especially high-frequency RF shielding structures, filtering characteristics of signal conditioning circuits, and PCB layout. The main impacts are reflected in: mass-produced models will need supplementary full-item EMC retesting, some models may require hardware iteration; extended testing cycles will put delivery schedules under pressure; and the archiving and management capability for raw data packages will become a new compliance threshold.

Medical device ODM/OEM manufacturers

As terminal equipment integrators serving the Japanese market, ODM companies must simultaneously bear the upstream sensor compliance risk. The main impacts are reflected in: they can no longer rely solely on unilateral supplier declarations of conformity, and must verify the completeness of EMC raw data packages batch by batch; if the sensors used do not pass the new certification in time, the registration/filing progress of the complete device will be hindered; and orders delivered to Japan after October 2026 will face the risk of rejection or return.

Medical equipment export trading companies

Trading service providers engaged in export agency, customs clearance, and compliance consulting for Japan need to update their technical document review checklists. The main impacts are reflected in: importer technical document reviews will add a verification step for EMC raw data packages; some signed but undelivered orders may trigger negotiations on supplemental contract clauses; and from the second half of 2026 onward, JIS T 0901 compliance status will become one of the key focus areas in on-site inspections by Japan's PMDA.

EMC testing and certification service organizations

Third-party laboratories qualified for IEC 60601-1-2 Edition 4 will face a concentrated release of testing demand. The main impacts are reflected in: 300 V/m RF immunity testing imposes higher requirements on site uniformity and field strength calibration accuracy, and some laboratories will need to upgrade TEM/GTEM chambers or open-area test configurations; non-technical requirements such as raw data package archiving formats and metadata labeling must also be incorporated into service processes.

What key points should relevant companies or practitioners pay attention to, and how should they respond at present

Confirm whether in-production models cover the key test items of the new standard

Immediately sort out the list of medical pressure sensor models sold to the Japanese market, compare them against the RF electromagnetic field immunity test conditions explicitly listed in Appendix B of JIS T 0901:2026 （frequency range, modulation method, field strength level）, identify any uncovered test points, and avoid relying solely on historical reports to “presume compliance”.

Initiate an assessment of third-party EMC organizations' capability to deliver raw data packages

Contact the currently cooperating EMC testing organizations and confirm in writing whether they support generating and delivering complete raw data packages in accordance with JIS T 0901:2026 requirements （including instrument model/serial number, calibration certificate number, test timestamp, unprocessed raw sampling data, etc.）, and retain written feedback records as a basis for subsequent compliance traceability.

Distinguish the legal effect of “pre-testing completed” and “declaration of conformity to the standard”

Please note that the “3 Chinese manufacturers completed pre-testing” mentioned in the information is an independent corporate action and does not mean that JIS certification or official recognition by Japan has been obtained; at present, there is still no public information indicating that JSA or PMDA has established an official certification pathway for this standard, and all compliance claims must ultimately be based on actual test reports after October 2026.

Reach a consensus with Japanese customers in advance on the pace of technical document updates

For orders signed before October 2026, it is recommended to proactively send written explanations to Japanese buyers, specifying the proposed transition plan （for example: providing supplementary test reports in batches, enabling new batches that have passed pre-testing, etc.）, so as to avoid commercial disputes caused by incomplete technical documentation at the time of delivery.

Editorial Viewpoint / Industry Observation

From an industry perspective, the release of JIS T 0901:2026 is more like a clear technical market-entry signal rather than a regulatory outcome that has already been fully implemented. In analysis, its core change——the 300 V/m RF immunity threshold——is not merely a numerical increase, but the incorporation of actual interference intensity in strong electromagnetic MRI environments into mandatory assessment, reflecting Japan's redefinition of the clinical safety boundary for medical sensors. From an observational perspective, the mandatory raw data package requirement essentially shifts compliance responsibility from being “result-oriented” to being “process-traceable”, which poses a new challenge to the quality data management systems of domestic enterprises. What deserves even more attention at present is that although this standard is a Japanese national standard, because it is highly aligned with the latest edition of IEC, it may become an important reference for subsequent revisions of similar standards in other Asia-Pacific regions.

Conclusion

The release of JIS T 0901:2026 marks that the reliability requirements for medical pressure sensors in strong electromagnetic environments have entered a new stage. It is not a routine standard update, but a systematic test of product design verification logic, testing evidence integrity, and the depth of supply chain coordination. At present, it is more appropriately understood as a compliance critical point with a clear timeline （October 2026）, quantifiable indicators （300 V/m）, and an already started countdown. Enterprises should treat it as a priority item for building technical compliance capabilities, rather than merely as a testing task.

Information source note

Main source: announcement on the official website of the Japanese Standards Association （JSA） （JIS T 0901:2026 release document, April 24, 2026）; items to continue monitoring: whether Japan's PMDA will issue supporting guidance for this standard, whether the JIS certification system will be adjusted accordingly, and whether the raw data package format of third-party laboratories will form an industry convention.