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Manufacturers need to demonstrate compliance with regulations regarding safety and performance requirements to ensure product safety and market entry.

The conformity of medical devices to EMC has recently become a significant issue, as it can pose a threat to life. If a product does not conform to the intended environment, it becomes difficult to ensure safety compliance and to achieve its intended effects. EMC testing evaluates the potential for interference between nearby products and the risk of injury or damage to people and the surrounding environment. Additionally, these tests assess the compatibility of devices under the intended electromagnetic environment. In many countries, EMC, radio, and radio frequency (RF) exposure and safety requirements are established. For medical products, several standards are set regarding testing, risk management, basic safety, and essential performance. For example, medical devices sold in the United States must comply with IEC 60601-1-2, 4th edition. The IEC 60601-1-2, 4th edition defines the fundamental safety and essential performance of medical devices concerning radiation and immunity to electromagnetic interference. As of the latest information, the U.S. Food and Drug Administration (FDA) has recognized the 4.1 edition as a Recognized Consensus Standard in December 2023.

Compliance with IEC 60601, IEC 61010, and various individual standards.

■ Technical consultation ■ Structural evaluation services ■ Contracted business testing ■ Testing laboratory accreditation ■ EMC testing and wireless standard testing ■ Radio wave regulations in various countries

Providing solutions for the global market.

■ Product safety standards evaluation, testing, and certification services ■ EMC testing services ■ Software evaluation services ■ Cybersecurity testing services for medical devices ■ Biological evaluation and biocompatibility testing services ■ ISO 13485 quality management system audit and registration services

In addition to the ISO 10993 series, it is possible to comply with FDA guidance, Ministry of Health, Labour and Welfare guidelines, and the United States Pharmacopeia (USP).

■ Biological evaluation plan and report (including toxicity evaluation) ■ Biocompatibility testing (ISO 10993/USP87, USP88) ■ Chemical analysis testing (ISO 10993-18) ■ Biocompatibility evaluation of respiratory gas pathways (ISO 18562) ■ Validation of cleaning and disinfection processes (ISO 17664-1 and -2, ISO 15883-5, ANSI/AAMI ST98 (US), etc.) ■ Validation of sterilization processes (steam sterilization) (ISO 17665-1) ■ Aseptic barrier systems and packaging systems (ISO 11607-1) ■ Peel testing (EN 868-5), burst testing (ASTM F 2054/F2054M-13), bubble testing (ASTM F 2096-11) ■ Air permeability testing and microbiological airtightness testing ■ Transportation testing and quality control of packaging materials ■ Packaging validation (ISO 11607-2)