On 2026年5月8日，日本经济产业省（METI）announced that the new medical device standard JIS T 0601-2-62:2026 would be mandatorily implemented effective immediately. This standard adds two mandatory test requirements for medical pressure sensors used in blood pressure monitoring devices and ventilators: step response time ≤20ms and radio-frequency electromagnetic field radiated immunity ≥10 V/m. Enterprises involved in the manufacturing, trade, and certification services of medical pressure sensors exported to Japan should pay close attention, as this directly affects the validity of PSE certification and market access qualifications.

Event Overview

Japan's Ministry of Economy, Trade and Industry（METI）officially announced on 2026年5月8日 that the JIS T 0601-2-62:2026 standard would be mandatorily implemented effective immediately. This standard applies to products corresponding to the international standard IEC 60601-2-62, which is identically adopted in the GB/T 16886 series, focusing on medical pressure sensors used in equipment such as blood pressure monitors and ventilators. The standard adds two mandatory technical requirements: first, the step response time must not exceed 20 milliseconds; second, radio-frequency electromagnetic field radiated immunity must reach or exceed 10 V/m. Relevant products previously certified under Japan's PSE certification must complete supplementary testing and submit proof of conformity before 2026年11月, otherwise they will lose qualification for access to the Japanese market.

Which Sub-sectors Will Be Affected

Direct Trading Enterprises

Companies exporting complete medical pressure sensor units or modules to the Japanese market will be directly constrained by certification validity. The impact is reflected in the following: if existing PSE certificates do not cover the new test items, they can no longer be used for customs clearance and sales filing; products that fail to complete supplementary testing after 2026年11月 may be rejected or removed from shelves by Japanese importers.

Processing and Manufacturing Enterprises

Enterprises engaged in the design, production, and assembly of medical pressure sensors need to reassess whether existing product hardware architectures and firmware logic can meet the 20ms step response requirement, and verify whether PCB layout, signal conditioning circuits, and shielding structures support 10 V/m radio-frequency immunity. The impact is mainly reflected in extended production line validation cycles, increased prototype retesting costs, and potential design iterations for some models.

Supply Chain Service Enterprises

Third-party institutions providing services such as PSE certification agency, EMC laboratory testing, and type test report preparation will face changes in business volume brought by the newly added test items. The impact is reflected in the following: orders will be concentrated in the second to third quarters of 2026; it is necessary to confirm whether partner laboratories have the qualifications and calibration capabilities for 10 V/m radiated immunity testing under the IEC 61000-4-3 standard.

What Key Points Should Relevant Enterprises or Practitioners Focus On, and How Should They Respond at Present

Confirm the Coverage Scope and Validity Period of Existing PSE Certificates

Immediately check the type approval documents of certified products to confirm whether the referenced standard version is JIS T 0601-2-62:2026, and whether the test reports include measured data for step response and radio-frequency immunity; if certification was issued under the old version of the standard, the supplementary testing process must be initiated.

Identify High-risk Product Models and Prioritize Pre-testing Arrangements

Focus on pressure sensor models exported to Japan and used in scenarios with high real-time requirements such as ventilators and dynamic blood pressure monitoring, and give priority to commissioning qualified laboratories to conduct baseline step response testing（such as square-wave excitation + oscilloscope sampling）and 10 V/m radiated immunity pre-scanning, so as to avoid delays caused by large-scale rectification.

Simultaneously Update Technical Documentation and Quality Management System Records

Revise the sections on dynamic performance and EMC in product technical specifications and risk management documents（ISO 14971）; clearly define work instructions for the newly added test items, equipment calibration plans, and personnel training records within the quality system to meet PSE factory audit requirements.

Editorial Viewpoint / Industry Observation

Observably, this standards upgrade is not an isolated technical adjustment, but a continued signal of Japan's increasingly stringent requirements for the fundamental performance and clinical reliability of medical sensors. Analysis shows, the 20ms step response time essentially targets ICU-grade dynamic blood pressure monitoring needs, while 10 V/m immunity is close to the stringent level required for life-support equipment in IEC 60601-1-2:2014 Edition 4. It is more appropriate to understand this as a regulatory signal —— although it has not yet resulted in large-scale recalls or sales bans, it has already constituted a definite threshold for new market access. The industry needs continued attention because METI or JISC may subsequently issue supplementary notices on transitional implementation details and interpretations of test methods, especially regarding the delineation of responsibility boundaries when sensors are integrated into complete equipment.

Conclusion

The mandatory implementation of JIS T 0601-2-62:2026 marks that Japan has put forward new quantifiable and verifiable requirements for the fundamental performance and electromagnetic compatibility of medical pressure sensors. Its industry significance lies in converting the implicit requirements for dynamic response and environmental robustness in clinical application scenarios into explicit compliance obligations in the certification process. At present, it is more appropriate to understand this as a technical market access rule that has already taken effect, rather than a policy proposal pending observation; relevant enterprises should regard it as a definite action in supply chain compliance management, rather than an uncertain risk.

Information Source Notes

Main sources: official announcement by Japan's Ministry of Economy, Trade and Industry（METI）on 2026年5月8日; the text of JIS T 0601-2-62:2026 issued by the Japanese Industrial Standards Committee（JISC）. Parts requiring continued observation: whether METI will subsequently issue implementation details regarding supplementary testing procedures, grace conditions during the transition period, or exemption scenarios for complete equipment integration.