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  1. Home
  2. Testing, Analysis and Measurement
  3. 一般財団法人日本品質保証機構 計量計測部門、総合製品安全部門
  4. Notice of Expansion of CB Certification Issuance Scope for Medical Device Testing (IEC 60601-2-37)
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  • Mar 30, 2021
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Mar 30, 2021

Notice of Expansion of CB Certification Issuance Scope for Medical Device Testing (IEC 60601-2-37)

一般財団法人日本品質保証機構 一般財団法人日本品質保証機構 計量計測部門、総合製品安全部門
The organization has registered the international standard: IEC 60601-2-37 (Particular requirements for the basic safety and essential performance of medical ultrasonic diagnostic and monitoring equipment) as the scope for issuing CB certificates, thereby expanding the scope of CB certificate and CB report issuance. ● Category MED (Medical Devices) ● Standard Numbers (1) IEC 60601-2-37:2007 (2) IEC 60601-2-37:2007/AMD1:2015 Our organization offers a wide range of services related to testing and certification for medical devices, including electrical safety testing and electromagnetic compatibility testing based on the IEC 60601-1 series, certification based on the Pharmaceuticals and Medical Devices Act (PMD Act), support for obtaining overseas certifications in Europe, North America, China, and management system certification based on ISO 13485. We propose a total solution for testing and certification related to medical devices. Please consider our medical device-related services.
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Notice of Expansion of CB Certificate Issuance Scope (IEC 60601-2-37)
International standard: IEC 60601-2-37 (Particular requirements for the basic safety and essential performance of medical ultrasonic diagnostic and monitoring equipment) has been registered as the scope for the issuance of CB certificates, and the scope of issuance for CB certificates and CB reports has been expanded.
Medical Device Testing
Tests are conducted based on domestic and international standards. As an NCB (National Certification Body) under the IECEE-CB system, we will issue CB certificates, reports with the ILAC logo based on ILAC-MRA, and test result certificates. Additionally, we also accept technical inquiries regarding standards for medical electrical equipment.

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EMC.PNG

EMC testing and certification services for automotive equipment and related devices.

"JQA Automotive EMC Laboratory Network" provides seamless testing solutions to enhance customer convenience.

We provide in-vehicle EMC testing services that respond to technological innovations such as electric vehicles (EVs) and autonomous driving, as well as the unique testing requirements of the automotive industry, at three locations: Tokyo, Nagoya, and Osaka. We are gradually equipping testing facilities that can accommodate international standards, including CISPR and ISO standards, as well as the standards of various automobile manufacturers. In addition to in-vehicle equipment EMC testing, we also support the acquisition of E-mark certification based on ECE Regulation 10 (R10), testing based on wireless communication regulations in various countries, and obtaining certifications in those countries, addressing a wide range of needs related to in-vehicle equipment. 【Main Testing Facilities】 - The Tokyo area has two anechoic chambers for in-vehicle equipment EMC testing, power supply equipment capable of supplying up to 1,000 volts, and a reverberation chamber, which have been operational since January 2021. - The Osaka area has two 10m anechoic chambers as a comprehensive EMC testing facility, and one anechoic chamber for in-vehicle equipment EMC testing has been operational since October 2019. - The Nagoya area has three anechoic chambers for in-vehicle equipment EMC testing, power supply equipment capable of supplying up to 1,000 volts, and a reverberation chamber, which have been operational since May 2021. *For more details, please refer to the PDF document or feel free to contact us.

  • EMC Testing

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Electromagnetic environment testing (EMC testing) for electrical equipment, medical devices, automotive equipment, etc.

Conducting tests based on domestic and international standards at four EMC testing facilities nationwide, equipped with 10m dark rooms and various testing equipment.

The EMC testing laboratory conducts internationally reliable tests compliant with ISO/IEC 17025, having obtained accreditation from VLAC, an ILAC-MRA accredited organization, as well as registration as a testing laboratory with IECEE and accreditation from Taiwan TAF. Please feel free to consult us for testing on weekends, holidays, or at night. 【Main Testing Contents】 ■ Testing subjects include electrical products, electronic devices, medical devices, automotive equipment, marine equipment, etc. ■ Testing for domestic certifications, etc. - EMI testing based on the Electrical Appliance and Material Safety Act - EMC testing based on the Pharmaceuticals and Medical Devices Act - Testing and certification based on the Radio Law - EMC testing based on S-JQA mark certification - JQA-EMC mark certification - EMI testing based on VCCI ■ Testing according to various domestic standards, international standards, national standards, and customer-specific internal standards using measurement criteria and methods - EMC testing (electromagnetic compatibility), EMI testing (emission), EMS testing (immunity) - Power harmonic testing - Voltage fluctuation and flicker testing - E-mark certification acquisition service for automotive equipment, specific tests for automotive equipment - GTEM cell testing, EMC testing for marine equipment, ELP mark testing, etc. *For more details, please refer to the PDF materials or feel free to contact us.

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一般財団法人日本品質保証機構
Testing, Analysis and Measurement
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Hyper CLT flooring panel

Confirmed through on-site demonstrations with construction companies | Hyper CLT flooring

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Hyper CLT sheets are not civil engineering materials created solely through theoretical examination. We have collaborated with actual construction companies and conducted repeated field tests to confirm their workability and usability on construction sites. We have laid them out in temporary roads, access routes, and heavy machinery work yards, verifying vehicle and machinery movement, installation and removal, and relocation within the site. By gathering feedback and usage conditions from the field, we are accumulating practical methods for utilizing wood CLT. Additionally, we are also verifying the unique characteristics of wood, such as lightness, glare reduction, noise suppression, and CO2 fixation, on-site. Hyper CLT sheets are registered with the Ministry of Land, Infrastructure, Transport and Tourism under NETIS technology "TH-250021-A." As a CLT sheet developed through practical demonstrations with construction companies, it is being utilized in various civil engineering projects.

Sep 05, 2026

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Please take a look at the technical document for the leak test, the "Technical Manual"!

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Fukuda Co., Ltd., which develops, manufactures, and sells leak testing equipment to inspect airtightness and sealing performance, provides a technical document that clearly explains the methods and theories of airtight testing, titled "Technical Manual." We are offering it as a PDF file. Please take this opportunity to download and view it!

Sep 04, 2026

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■■ Leak test for pouch containers such as packed rice! | MSQ-2003 series ■■ Packaging container air leak test device, pinhole inspection device, and full inspection device.

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The pinhole inspection for packaging engineering is fully automated, eliminating packaging defects based on certain quality standards. The judgment results and operational status can be managed via a monitor screen. - Quantitative management of quality standards for the pinhole inspection process - Ensuring the quality of the product's shelf life - Establishing evaluation criteria for the manufacturing process, achieving quantitative quality assurance - Slim and space-saving design that can be connected to existing production lines - Quick changeover for product variety switching can be handled in a short time by exchanging chambers - Fully domestically produced, allowing for rapid maintenance and troubleshooting - Example target works: pillow packaging, packaged rice (packaged cooked rice), etc. *Please consult us regarding the use of this product for pharmaceuticals.

Sep 04, 2026

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Release of IsoLite Industrial's 3mm 1600SF Blanket.

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IsoLite Industrial 1600SF Blanket with 3mm thickness has arrived. ■ This product is not subject to the Specific Chemical Substances Hazard Prevention Regulations (Tokka Regulations) by the Ministry of Health, Labour and Welfare. For more details, please contact us.

Sep 04, 2026

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Fukuda's leak test, leak inspection, leak detection, leak test, integrity test.

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Fukuda Co., Ltd. has been pursuing leak detection for 60 years and is committed to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing properties. We will propose the appropriate testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

Sep 04, 2026

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